Bionano Genomics, Inc. (BNGO) Earnings Call Transcript & Summary

Okay. Welcome back, everybody, to our second panel. We just heard from some really, really interesting companies on the cell therapy side of COVID. We want to turn our attention now. So it's on so many people's minds these days, especially with everything reopening, enough testing. We need it. We really don't seem to have enough of it, but that is really changing, much of which you're going to hear from some of the companies on this panel today. So there's been a tremendous amount of availability and accessibility that these companies have contributed to. We're also learning a tremendous amount about susceptibility at the genomic level, we're going to hear a little bit about that. But there still seems to be a lot of confusion when you just talk to random people about where testing is in the space, then we're going to try to clear that air with this panel. So with that, I want to introduce our panelists, our presenting companies, who will reach out, give you a short presentation before we talk about everything that's going on in testing. That includes Dr. James Hayward, welcoming him back from Applied DNA Sciences. They're doing some tremendous work in vaccines, but they also have very interesting testing platform. Biocept, Michael Nall, Chief Executive Officer. His company is doing tremendous things in Southern California on the PCR-based testing side. Bionano Genomics, back to my point about susceptibility and understanding structural variations. So we'll hear from Erik Holmlin or Dr. Holmlin from Bionano Genomics. Co-Diagnostics, which has captured tremendous amount of headlines with their PCR-based kit using CoPrimer technology. So we welcome Dwight Egan, the CEO of the company, to give us a talk there. And Cameron Reynolds from VolitionRx, Chief Executive Officer, looking at the epigenetics side and the nucleosome side, something you don't hear tremendously a lot about, but certainly has a very significant role, and it's a different look at testing and understanding coronavirus. So with that, let me go back to Applied DNA Sciences, Dr. Jim Hayward, who will kick us off on the testing panel for an update on what Applied is doing on the testing front. So Jim?

Sure. Thank you very much, Jason. Well, first of all, I'd like to thank you and your Maxim colleagues. I am a molecular biologist and the President and CEO of Applied, company traded on NASDAQ, as you can see behind me. With the call letters APDN. Our company uses a unique, very familiar platform for this audience and that is PCR at very large-scale for the manufacturer of DNA. We utilized the linear DNA produced by PCR in health care for both the manufactured nucleic acid therapies and for diagnostics and serve more than 20 CRO and CMO customers, who use our platform and take use of our extensive IP portfolio to improve their construct. With relation to COVID-19, we have used our linear DNA platform to target spike in both the unique vaccine strategy and in nucleic acid diagnostic. And I believe we are one of the only companies engaged in both the detection of virus and in protecting patients. So like our approach to vaccines, we utilize the S gene for a real-time reverse transcript based PCR, which is multiplexed and performed in a single well for efficiency. We announced on the 14th of May that the FDA had granted our Emergency Use Authorization for complex molecular testing for SARS-CoV on a broad base of sample types that included upper respiratory samples, including nasal swabs, self-collected at a health care location or collected by a health care worker. And nasopharyngeal swabs and oral pharyngeal swabs and nasopharyngeal wash or aspirates or nasal aspirates, collected by a health care worker from individuals who are suspected of COVID-19. We are just completing validation of saliva, and we'll be filing our amendment with FDA shortly. We've begun the testing of home sampling systems for saliva as well. And we are developing our kit for desktop PCR on a small-scale device for point-of-care testing. Our specific goal is to make testing easier on both patients and health care workers and to make testing more available and faster. That's really what we need to fight this pandemic now. Now the principles of design for us were to ensure very high sensitivity, which we achieved, very low limit of detection, low opportunity for false negatives, and to achieve high throughputs, to enable the same-day reporting to the physician who ordered the test and to test large portions of the patient population, but also the population of health care workers and the workforce of communities and larger companies as we contemplate the reopening of this economy. And very importantly, to ensure that our test was robust enough to detect the growing number of variants. And we were successful in all these fronts and provided that [ evidence ] to FDA. To the next slide, please. We've successfully manufactured QC released, filled and finished our first lot and anticipate the commencement of shipping shortly. Our approach to monetization is profiled here. We're especially motivated to contribute to regional populations in Stony Brook, Long Island and New York State, but of course, we'll pursue business globally as well. Our first customer is Stony Brook University Hospital and its network of facilities on services and our hope is to improve the testing of patients and staff, to facilitate the compliance of nursing homes and adult care facilities with Governor Cuomo's requirement to be tested twice a week. And it would be hard to imagine or gain compliance with this requirement, if the only way to test was through nasopharyngeal swabs. But with our methods, we believe we'll be able to recruit compliance quickly. And as we approach the next phase of this pandemic and the opening of the economy, including companies and universities, we're well positioned to work with health care partners to facilitate easy sampling and high-volume quick turnaround testing. We anticipate opening our own certified CLIA lab. We've been talking with companies who want to test their staff at high frequencies and to respond to regional hotspots as soon as they arise. We've begun talking to partners for mobile testing labs. Our team of IT experts is helping with the robotic integration to further increase throughput and to leverage our extensive integrating and quantitative experience to maximize data value. And as we integrate our systems with hospital data, management systems. And with that, I thank you. Well, couldn't hear you, Jason.

Jason, you're muted.

You're muted.

Still never getting used to this, muting and unmuting. So I'll turn it over to Michael Nall at Biocept, company that's helping service Southern California on the testing side. A lot of questions for -- with that plug you to the panel. Let me turn it over to Michael to give you an update on what Biocept is doing. Okay. Michael, yes, that's okay.

Hi guys, we're just having a little bit of technical difficulty, but I think that the guys are helping me right now. So I'm getting ready to put in my, call-in via my phone. So actually, if you can hear me, I'll just go. And then we'll sort that out over time. So thank you, guys. So at Biocept, we're one of the leaders in liquid biopsy. And of course, I'll be making forward-looking statements. I encourage you to review the filings we have at the SEC to assess the risk investing in our company. So about Biocept. Well, you all might know us already. We're one of the leaders in liquid biopsy. And liquid biopsy is a way that we help patients who have been diagnosed with cancer. So we do our testing here in San Diego. And we get specimens from all over the world. We get specimens primarily, though, from the U.S., about 80% of our volume, is from the U.S., about 20% outside the U.S. Now liquid biopsy and oncology is forecasted to be a very large potential opportunity into the billions. And if you think about it, everyone who's diagnosed with cancer today needs to have a surgical tissue biopsy. In the future, we'll be able to move that more and more to blood and other bodily fluids, such as cerebral spinal fluid for the people with brain metastases. Now we focus our test menu that we provide results on actual information. These are biomarkers that qualify patients for therapies. You all probably see the advertisements all of the time on TV for KEYTRUDA, for people with lung cancer, and we would do testing for PD-L1 to, qualified folks for KEYTRUDA. Now we have very high concordance with these tissue biopsies, and that gives physicians confidence in ordering our test. In fact, we just have presented data and published data a couple of months ago in a peer-reviewed journal that showed 93% conformance with a tissue biopsy. So physicians routinely are using our test as a substitute when they can for tissue biopsy. We've been able to create a lot of strategic partnerships, and we're going to talk today about our COVID-19 offering, and we're partnered with our good partners at Thermo Fisher Scientific there, with their tech path assay. And then we do have a lot of global sales. We partnered with AstraZeneca for testing in Latin America. And we're also selling our assays that we normally provide in our own laboratory in San Diego in kits or boxes that other laboratories can use primarily outside the U.S. in their own labs, and that's a growing part of our business. So next slide, please. So we've launched our testing about a month ago now, and we're getting ready to start to widely market. We do the Thermo Fisher TaqPath assay here, and we -- one thing we didn't anticipate was the need to be able to have the collection kits. So there's a big shortage. And one of the things we may be talking about isn't necessarily a shortage in capacity of testing like a lot of folks may think when you listen to the news reports. It's actually the collection kits and primarily the media that you need to transport that in. So they're being rationed today. So to get around that, we've decided to manufacture our own specimen collection kits, and we should have those out in June sometime. So that allows to widely market the test. Huge opportunity even here in California. As you may have heard Governor Newsom wants to see widespread testing for all the citizens in California. And if that does become the case, we'll be very busy with testing from here. In the meantime, though, we can do today about 400 tests per day, and we can ramp that to about 3,000 with no more instrument purchase. I would need to hire a couple more people probably for accessioning on the front end and reporting on the back side to get to that kind of volume. But we can do about 400 today without any other investment. It's a very automatable test. One thing so -- I always ask about is, about the reimbursement. And so we are very thankful that Medicare improved the reimbursement on the test from the original $51, up to about $100. Now that's still a lower margin and lower price point. To give you a comparison, for our cancer diagnostic testing, we average about $1,400 per patient. And so with the COVID testing, you're about $100 with Medicare. So -- but we're doing this as a way to help folks, as a way as a way also to shore up some of the revenue due to the impact of the COVID-19 pandemic to our existing volume, as you've seen throughout health care. So now for the folks on the call that are listening, I think one of the challenges is, patients -- and just all of us that are healthy, don't really understand who needs to be tested, how do you get tested as well. And folks should understand that in the CARES Act, it's mandated that your insurance or Medicare government payer has to pay for the testing. So that's a big message folks should get out there. That they shouldn't have out-of-pocket with the testing. And on top of that, in the case of Medicare, you no longer need a physician order. So now some private payers do require physician order, but you don't need to be symptomatic. And I think that's the take-home message for all the investors that folks need to understand that, anyone can have the test that wants it today and in fact, we want more and more folks to be tested. I'm involved in some of the task force as we're trying to decide how to encourage more widespread testing for people. And one of the critical factors is getting folks educated about the need for testing, both for -- as the people come back to work over the coming months as well as everyone to identify who could be asymptomatic carriers, likely, to impact others. So we need everyone to be tested. So excited to have this conversation. And as the other guys do their introductions, I'm going to get back and work on my IT issues to get that worked out. Thank you, Jason.

Michael, it sounds like you're coming through clear. It looks all good for now, but they'll -- keep working on it. Now I want to move over to Bionano Genomics. And it is so much talk and excitement around testing, understanding who's susceptible. And then there's documented literature that there are changes in your genomic level that make 1 person susceptible and maybe not another, even in your own household. And Dr. Erik Holmlin, the CEO of Bionano, is going to help us understand how his Saphyr unit can really play a role here. So let me let Erik give you an update on where Bionano is in coronavirus?

Terrific, Jason, and hi, everybody, and hello to the fellow panelists here. Michael is maybe 5 or 6 miles away here in San Diego. So we are -- the Southern California team on the panel, I guess. I really do want to talk to you about a lot of exciting progress that's happening using our platform in genome analysis, focused on addressing the specific question of what types of expectations for the COVID disease should an individual have based on their genomic composition. And before I get into that topic, I want to introduce some very basic genome biology. It's really important that people following Bionano, which is publicly-traded, covered by Jason, who does a great job, understand that the genomic variations that drive diseases are not all the same. And structural variations are a class of genomic variations that are particularly difficult to detect using sequencers and other genome analysis tools. So structural variations make up large rearrangements of chromosomal structure. They're pictured on this slide here, deletions, insertions, repeat expansions, inversions, translocations, involving events within a single chromosome and between chromosomes and structural variations are highly relevant in cancer especially, hematologic malignancies, where 90% of them are modulated and driven and caused by some form of structural variation, about 50% of solid tumors and then a host of inherited constitutional diseases. And it is believed very broadly throughout the genome analysis community, that structural variation in a human genome will make up a large factor in the way in which a patient responds to COVID-19 exposure. So on the next slide, I'm summarizing some examples of where structural variations have been a factor in either protecting or increasing susceptibility to infectious diseases that we know of. Malaria, HIV, Hepatitis C and others have modulated host responses, and this is well known. In some cases, it's protective. So it renders the infection relatively mild. In some cases, they can be a prognosticator of severe outcome. Obviously, COVID-19 is a brand-new situation. And so our understanding of how the symptoms of 1 patient versus another of a similar risk profile, how there's significant variation in what drives that. The understanding there is very, very poor. The platform that we offer, Saphyr is the only system capable of a very comprehensive and cost-effective approach to reviewing all structural variations. And so what I mean here is that, any type of structural variation as long as it's 500 base pairs and bigger can be detected very robustly on the Saphyr platform, and that cannot be said of any other genome analysis platform. So on the next slide, I'm summarizing for you a number of studies that are getting underway where, researchers around the globe, now in North America, Europe and Asia are using Saphyr to study patient populations of COVID-infected people. And those populations range from a variety -- are comprised of a variety of subpopulations. We have great access to a number of samples, starting with our partners in Wuhan, Hubei province, which we all know is thought to be ground 0 for the current crisis and through relationships that we have there with a Saphyr user, we have an initial cohort of 100 samples that are being analyzed. And these range from pediatric patients, elderly patients, mild symptoms, severe symptoms, recovered, deceased and so this is a project that is getting underway with the support of the Chinese government. There's a very similar program ongoing in Germany led by the University of Hannover. And their expectation is to analyze roughly 1,000 patients as part of this RESIST cluster, and they're using all of the tools that are available because they're very desperate to be able to segment patients according to some sort of risk profile. The assumption is that in the long run, we're going to need to meter out and ration, things like a vaccine when available, treatments when available, and even now access to various forms of care within the hospital, ICU beds, ventilators and so forth and that some type of risk profiling of patients at the outset will play a key role in that form of management. The last group listed here is Augusta University in Augusta, Georgia. And actually, we got an update from them yesterday, and they've been working through an initial cohort of 30 hospitalized patients. And I can tell you that, they are already revealing patterns that would seem to suggest that there are some unique protective structural variations in the human genome where if you have them, you're likely to have a milder disease. Now this is very preliminary and many more patients need to be studied. But Augusta has formed a COVID-19 Host Genome Structural Variation Consortium, and they expect the CDC to get involved at a number of other institutions on a global basis in an effort to analyze their own 1,000 patients using the Saphyr system. The reason again Saphyr is so important for this analysis is it's really the only platform that gives you this window into the structural variation of the genome and how that's driving COVID disease in patients. And so for Bionano, we see this as a significant economic opportunity in the midst of overall disruption of the rest of our business, like other panelists have mentioned, things like oncology, research are on hold. A lot of discovery programs are on hold or delayed significantly. But the interest in uncovering the underlying basis of COVID response in patients is very high. And we see that as being a form of economic opportunity and also something very significant, important for us as human beings on a go-forward basis. So thank you for the opportunity to talk about it, Jason.

Great. Thank you, Erik. Moving on to Dwight Egan, CEO of Co-Diagnostics, name that's really captured a lot of headlines. I've met Dwight and his group, long before COVID. And one of the reasons we launched coverage, I think even a middle schooler can understand it. Certainly everybody on this panel, including myself, being a former scientist that their technology gets rid of primer dimers, so you can imagine PCR, what that means. So I'll let Dwight give an update on where his group is today. Dwight?

Thank you, and good morning, and good afternoon, everyone. And a special hello to all of my colleagues on the panel and to you, Jason. I'm going to be making some forward-looking statements as part of this presentation. So I encourage you to look at our filings with the SEC with respect to these types of statements. As Jason indicated, our tests are built on a unique platform, which is our own patented platform, which we refer to as cooperative primers or Co-Primers. Co-Primers are a unique molecular construct that give our test particular attributes. It comprises a single molecule that has a primer and a probe that are connected together with a linker, and they react in a particular way inside of a PCR reaction. And the sort of hallmark of Co-Primers is the elimination of primer dimers. And a result of that is that, we're able to do tests that are multiplex tests with great ease, with no cross reactivity. And they have some other important attributes as well, but that becomes the most important aspect as we approach what we're doing with COVID-19. The elimination of primer dimers and the multiplex and without cross reactivity, enables us to have tests that are highly specific and accurate. As we have indicated to the public, we are in the development of some additional tests that will provide durability and continuity for our customers going forward. We've commenced a feasibility study for a viral antibody test that will do both of them in 1 reaction. We've also commenced and have already well along the way in a differentiation tests for COVID-19 is in the context of other upper respiratory infections so that we can differentiate between the patients say in a grade school in November that where somebody sneezes, and you need to know whether they've got COVID-19 or any of a number of other upper respiratory diseases. We've already begun and designed a test that detects the mutation, which is known as the D614G mutation, which has higher transmissibility and also it's is creating higher viral loads in patients. So what we want to do for our customers is provide a platform that once they get engaged with us, that they have durability in the coming months and years that we'll be dealing with the COVID-19 as a specific public health problem throughout the world. We go to the next slide now. So our COVID-19 test is, as I mentioned, engineered using this pounded CoPrimer technology. It -- we sort of have a 3-pronged approach to evaluating how our value proposition to the world and that is, first of all, in performance. This is a highly accurate test in terms of sensitivity and specificity, which everybody knows are the 2 main benchmarks for accuracy. This test has been validated in numerous studies throughout the world. We have our own manufacturing plant through a joint venture in India. So this test has been -- has gone through substantial validation at the National Institute of Urology in India. It's also been studied extensively at the InDRE in Mexico, which you have to have in order to get into that market. It's been studied in Australia, in places in the United States and abroad in numerous studies showing the excellent performance and characteristics of the test. The second prong is price. We have built a company that tests for things like tuberculosis and hepatitis B and C and malaria and these types of diseases that particularly plague the developing world. And so pricing is an important aspect of our product offering. And we do a compassionate pricing around the world. We've adopted that same policy with respect to our COVID-19 pricing. So one of the reasons I think we have great success throughout the world is that our pricing is relevant to the nations and cultures in which we sell it, including into the United States. The next issue is with respect to our value proposition is our throughput issue. And we've been able to set up laboratories in different places throughout the world that are using very high throughput systems to generate a large number of tests on a daily basis. And being that our technology is an open architecture, we're able to be used on systems throughout the world that are a variety of different PCR machines and such, and this is an important aspect. But throughput becomes the third prong of our value proposition. And we can go to the next slide. As I mentioned, we've had success throughout the world. We are currently distributing to nearly 50 countries throughout the world and at least 15 or more of the states in the United States. And this global network now of distributors gives us a platform to take not only our current COVID-19 offering, but our forthcoming offerings that we anticipate with respect to differentiation. And with respect to the new mutations that may come up. And with respect to our hopeful success in the context of a viral antibody test that is done in 1 test. That concludes my initial presentation. I'll turn it back to you, Jason.

Thank you. Thank you, Dwight. We'll move on to VolitionRx, Cameron Reynolds, CEO, talk about a very different approach. We heard a lot about PCR and DNA, and we also hear a lot about antibodies, but we don't hear a lot about nucleosomes, their technology NuQ and how it's applicable potentially to coronavirus. So I'll let Cameron give you an update on where Volition is today.

Thank you. I hope you can hear everyone, and welcome, everyone, listening and to the panelists. I'll walk you quickly through what Volition does in general, and what we're going to try and assist with the COVID crisis. As we've discussed before, we make some forward-looking statements, so please read that and in our filings. So who are we? Volition, we're also listed on the New York Stock Exchange, with symbol VNRX. We've been public for about 5 years now. We're a multinational epigenetics company, headquartered in Texas and offices around the world, with our big corporate headquarters where the research is done, and that headquarters in Belgium, and our corporate headquarters in Texas. And we've developed a suite of novel epigenetic tools to be used initially in cancer, but also for other diseases, and I'll go through today, how that's will be working COVID. And we're the first group to look at new specimens in circulation if anything like this way. So we've been around 9.5 years now. So we have an extremely large and granted patent portfolio, which centers around all the structures on the nucleosome in circulation, methods, detection as well as the biomarkers in different jurisdictions. So we think epigenetic is incredibly important in cancer, in humans and animals, which you can see, we have a lot of good videos on our website. We'll go through the technology and the people and our area. But this presentation is on hold. So I'll go to the next slide. So you might be thinking COVID is a virus, how -- it is got to do with epigenetics? Fair question. So I'll just run you quickly through the theory of what data we have and the plan moving forward. The body does several things, defend itself against the virus, one of which involves white blood cells, which helps check the body against this infection around us. The white cells in both the virus and also other bacteria, and the body also produces antibodies. So -- but in addition, and this is something, we've just been working on in the last couple of years, beginning, this is the same mechanism in influenza and in flu and pneumonia. The body -- the white cells, throw out a lot of collagen, which is where the epigenetics come in. It's called NETs, Neutrophil Extracellular Traps. So the acronym [indiscernible]. And if you look under the [ EPA ] micro service, what you're doing really are NETs approaching, which physically infect the virus, which you're probably aware, it's often respiratory infection and white cells migrate to the lungs, and they won't protect the lungs, unlike anything, it's good is if it happens correctly. If you have the right amount of NETs, it's response, which is very valid. But in situations, SARS, a severe acute respiratory syndrome and pneumonia, they are associated with a very high level of hyper immune response, involving a massive injection, medicines into the white blood cells, which highly damage the lungs and this is actually what kills a very large number of people in COVID. So again, how is this -- we think epigenetics is incredibly important in cancer and the other diseases. And the NETs themselves along with nucleosomes, which are new concerns. So the difference in the case they are detecting. We typically detect a mono nucleosomes, like sickle cell people. But the mono nucleosomes are what we typically look forward in the cancer, and there are thousands structures on there, which are very varied. And we have a very simple platform, ELISA base at very low cost, very easy to use, small blot of blood. We've been developing for a long time now to be used in other things. But obviously, COVID is a big crisis, and there is a very big need for a prognostic for those of you who aren't seem to be at the moment a diagnostic tells you, if you have it. A prognostic tells you, are you going to be entitled from the virus. As you might know, COVID is characterized by a lot of people who had very low symptoms or no symptoms. And a percentage of people who are getting is a real problem. So the percentage who are getting through the problem, while the main reasons for that is then the lungs still with NETs, which we detect through a very simple, very easy to use, very low-cost nucleosome assays. So what we're going to focus now is trying to develop a prognostic, and there's very little prognostic value in the markets out there. The people were trialing with the trial a few things. Some inflammatory markers like CRP, [indiscernible] and LDH, but certainly, something better quicker and easier resource, is a good process. So we're in the process of clinically testing assays, which are very, very similar. We've got exactly the same as for the cancer, but not detected in sleeping nucleosomes but long changing nucleosomes from the NETs. So next slide, please. So our goal is to develop a clinical useful product as against, as a prognostic. We filed a patent. This is all very novel looking -- using the epigenetic markers to -- as a prognostic in the virus. So we have filed intellectual property, and it broadens our very strong intellectual property. So the first level of the trial we've done and is now completed. We're doing a key steps, roughly a month at a time. It can happen very quickly as a platform has been fully developed for the other diseases we're looking at, also in animals and humans. So potentially other diseases. So it's a platform, which is going to be done on microtiter plates or magnetic B, both of which have developed. So the first data we released just a few weeks ago. That is the first step is to show we had very good discrimination between healthy controllers and people with COVID. As you can see from the data there, it was almost 99% protection rate, which is actually caught us by surprise. We weren't really expecting to see that level of discrimination which might be one single assay, which costs very little to manufacturing, it can run anywhere, any institution in the world. Very exciting, but we were not looking for diagnostics solutions -- for prognostic. There are other people here who have diagnostics, and there's other ways of doing the PCR. So that was the first step, it was a very encouraging result. What we're doing now is working with 2 hospitals in Europe who are collecting high, medium and low symptoms COVID, which lead a differentiation and serial samples from the same people. So if I, unfortunately, was in hospital with symptoms of COVID, I take my blood on the first day, second day and days after we see it -- a good churn between the healthy, the medium symptoms and the high symptoms. With the aim of saying, if you could have a blood markers to see, days before, you got into serious problem. If you could see in today's report from a very simple blood marker, which can be run in any lab. So we'll have that data very soon, as we're running the trials now. We expect them to have at this quarter. Again, to be clear, we do not have a product today. This is all a very good processes we could argue, but we should have a very good indication very soon. If it is a good prognostic marker, if we can tell the people ahead of time who is going to be in bubble, and the intensive care or a ventilator and who is not, between their moments of isolate, it can be very different black strips possible. I think it's going to be a very big product, and it could be something we can launch very quickly worldwide, given all the work we've done on the platform previously. We're investing each NET making a very robust, very reusable, reliable lager based platform and this fits in with what we've been trying to do, make an epigenetics toolbox between the impaired set in animals, we have very cloudy [ dictator ] as well. Animals, that decided we have [indiscernible] and decided to release was [indiscernible] something we have incurred, I think it will be very helping season, if we can show a differentiation between severe symptoms and no symptoms. So that's where we are. And we should have local data very soon with the hospitals. And that's the test we're having for the COVID market.

When it comes to testing, there is so much to unpack and understand. I don't think there's a person in this country who's concerned on some levels, on spectrum. But before we go into the actual core testing per se, I want to start with Erik Holmlin's Group. And it touches on what he's doing is -- it touches on something I think everybody talks about, even in your own house is, if you're exposed, what's the rest that I now give it to somebody in my house, they're houses where 1 person as well, even I know people, but nobody else got sick, and there's another house where somebody did. And everybody got sick, and then there's the -- you don't even have to break it down internationally. You could break it down right here. There's a disproportionate amount of people that seem to be of African-American descent that may be more susceptible. How do we understand more clearly what you're doing, Erik? And how is it applicable to the broader population, not just from publishing papers on, understanding susceptibility broadly, but here. Like how does my neighbor understand if they're susceptible?

Yes. So I mean, I think to me, that is probably the most fundamental question because exposure is increasing constantly. And there are many who view that we've already all been mostly exposed in most cities, for example, going to the grocery store or whatever we've been doing during our stay at home time. And so the question should really be, what happened after exposure. And I think, practically speaking, and to be fair to the nongenome analysis fans out there, viral load is probably the #1 most significant -- the sort of degree of exposure and inoculation is probably the most significant initial parameter. But once we go beyond that, how our cells are composed in our upper respiratory system in a way that the virus can invade those cells is going to determine what happens. And that cellular composition is driven by genetic and even if Cameron wasn't here, I would say, epigenetic makeup. And we need to begin to catalog these things and create -- I mean, these are going to be big studies because the genomes and epigenomes are going to be highly variable across them. As we study these samples, they're going to highlight all sorts of variation that is just background variation. But many of the answers to the questions you're talking about lie in the genomes and the key to getting them is to doing the studies that are getting underway. This is something that has to be undertaken on an international scale, a massive scale. And it's just as important as the diagnostic testing that's going on. But I think we were behind on this stage. However, I think the interest is very high and research into susceptibility in the genetic drivers is increasing.

So that leads into -- before I still, again, before we get into the testing, testing, everybody -- these -- everybody here is making tremendous contributions. And this is an open-ended question for anybody. Help people understand where the large testing players stand here because they were touted, the lab cores and such, Abbott's, [ Cepheid's ] has being answered to this, and we're finding out that, that's not really the case. And help people understand a little bit, maybe we'll start with Michael Nall where an Abbott or a Cepheid and their box "for testing" fits into here. And maybe, Dwight, you could follow-up on that with the throughput angle that's related to what they're doing.

Well, Jason, I think that's a critical question. And I think we have an opportunity today to also, as you're doing throughout these symposiums is to educate the folks that have logged in. And there's a real misunderstanding about the types of tests, I think, in the general population out there today. And there's -- today, what's marketed or either going to be an RNA test generally, like we're performing or DNA or there's the antibody test, which will look to see whether you've been exposed. So that's a critical thing for folks to understand. And some tests are going to identify whether you had exposure to the test and you've developed antibodies. But that doesn't tell you, if you have active virus in you. And when we think about other viruses, it's important to monitor and look for the amount that's left before you are considered noninfected. And so that's one of the big challenges we're facing as employer. As a country is understanding when to use the appropriate test. And I think, the answer to your question is, they're kind of complementary, right? We need to be looking at this from all different areas. And both physicians as well as the overall population needs a lot more education about the right test at the right time. I'm involved in a couple of the task forces, that I said, and here in, San Diego, we have something called Biocom, which I think Erik is probably also a member of, and we are as well. And we're trying to assess recommendation for all the Biocom members, which is biotech companies, as you might expect, as the proper way to test their employees and even a Biocept. We're debating that. So here, we do the testing, and we're getting ready to require the testing for all of our employees, but we have great debates on the frequency because is it practical to run my platform on a daily basis for all these patients for every 2 days, as I believe Jim talked about in New York, or is it going to be every 2 weeks? Is it going to be every month? These are all the things that really need to be sorted out, and we need to have a conversation nationally about the proper way to integrate folks back into society. And a couple of the other things of that, the importance of these tests to identify and better triage who's really at risk in the host of the virus and who's not as greater risk. And that's really important for the patients that have been affected. Happy to let somebody else have a say as well.

Maybe, Dwight, you could talk a bit about that -- Erik spoken about a week ago about throughput, throughput, it's all got to be throughput. And when people are being steered towards things like Abbott and Cepheid, that doesn't really answer the throughput question. Maybe you can comment a little bit about that.

Thank you. Let's talk a little bit about the whole layer of the land. We have a wide diversity in our population as to how susceptibility occurs. Just where our facility is located in Salt Lake City, Utah, where we have about 3 million people in the metroplex. I can think of 3 different groups of people that have been tested widely in Utah County and Salt Lake County and on the West side of Salt Lake City. One shows prevalence of about 2% of a positive test result. The average for the state is about 4.2%. And in 1 particular area, comprising several communities, it's as high as almost 20%. You have the same kind of situation in New York where you have between 20% with 1 group and up to almost 40% amongst another group or a recent study in Stanford in Santa Clara, showed that only 1.8% of the population showed with an antibody test has having been infected. And so there are a lot of different variations of what happens here, who gets tested? Recently in Salt Lake City, another company began testing solely for the antibodies. You drive up in your car and you pay $70 to get an antibody test. So far, the results are 11% as they were reported last night of the patients who have come through that facility. Now 11% means that we haven't got very much prevalence yet in Salt Lake City. And without prevalence, a test for antibodies, doesn't do us a lot of good because arguably, 80% or 90% of the tests are going to be negative, if we don't have enough prevalence. So the only way we get a hold of this, I think is -- and I think most experts agree, is through massive testing and tracing. The Harvard study that recently came out suggesting that by the 1st of June, we need to be doing 5 million tests a day. And by the end of July, as many as 20 million a day, I think are important studies to pay attention to because if we're going to get 76 million kids back-to-school, including our colleges and if we're going to get 157 million Americans back to work, we're going to have to test regularly and massively and trace after that, what I call TNT, in order to get a solution here and get people comfortable that they're safe. It would be another thing, if this virus didn't kill you or make it so, that if you visited grandma, you might kill her. But this is a pervasive beast, and we have to do massive testing and tracing. Now with respect to the throughput issue, this is key. And the kinds of -- it's not just in terms of the laboratory being able to test a lot of people at once. It's the ability to get a methodology of taking a sample that can be readily done in an office, in a school, so for instance, it's been mentioned today on the panel, and we're very active in this same initiative, live testing because that is a self-administered test that can be done by virtually anybody. It could be done in the home, in the school, at the office. And as we deploy these types of technologies for collection and do mass testing on -- millions of tests being done on a daily basis, then I think we'll start to get a hold of it.

It's also where Cepheid and Abbott. I remember we've written extensively on all aspects of COVID over the last couple of months, and 1 of them has been testing, of course, and I remember watching on TV, the first news story is the Apotex. And I'm looking at the box that they have and it puts like 1 test. And then people are lined up around the corner is not practical, is that a place more for in the hospital when you need to know, if a surgical patient right now has coronavirus, so they could proceed. Is that a place for Abbott, and then we need to get back to the more broad testing scalable PCR?

You're very right there, Jason. The -- and nobody on this panel would want to speak disparagingly of anybody else's test. It's -- no company is going to be able to handle this on their own. It's going to take all kinds of different solutions. And the kind of solutions that are provided by some companies are what we would refer to as one-off tests. In other words, it takes a closed system, a specific box to do the analytics and a specific cartridge or a set of consumables that go along with that box. And typically, a one-off solution is not going to cut it when we're talking about what I'm talking about, which is massive testing and tracing. But it is going to be very relevant inside a hospital, for example, where a surgical team is going into surgery in the next 2 hours, and they need to know right now whether that patient is actively infected. And the way to do that and to do it efficiently is with one of these off -- one-off tests that are done by a number of different companies. And then they can know when they go into the operation, whether they've got to don PP&E equipment or other more protective measures so that everybody doesn't get infected by just doing the operation. So I think they all have a place. Our place is in massive throughput in an open architecture environment that can be used all over the world by virtually any reasonable CLIA lab on the planet.

Right, which makes sense for scalability that falls into Michael's bucket, but also to you, James. In terms of large mass-scale testing, is it just not possible or not practical to do it with LabCorp nationally? Is it better -- best suited like what you're doing at Stony Brook, where you can service the regional area of New York? And Michael Nall, you can service maybe Southern California or something to that effect. Jim, is that -- are we thinking about that correctly?

Well, I would agree with Dwight's comments and I think take a diversity of approaches. And our approach is to try to move as quickly as we can, and I think we can do that regionally the best. With regard to some of your other questions a moment back also, I think we're missing an opportunity for machine learning and bioinformatics, to be honest. It's kind of funny when you look at -- most of the EUAs are for qPCR assays. And yet the quantitative aspect is completely ignored, and the qualitative result is reduced to red/green response. Yet that -- those data are there. And there's been a great reluctance to provide viral load or quantitative CT values back to the attending physicians because of the tendency of this disease to compartmentalize in the early phase to be in the upper respiratory system, and those counts from the nasopharyngeal swab can go down when the disease then compartmentalizes in the lower respiratory system or if it goes to the intestines or the heart or the kidney or what have you. But if we can find a more common sampling method, like maybe it's as simple as saliva that reflects -- or morning saliva so that you get both the upper and the lower airways, that reflects a better representation of what the overall viral dose is in the patient. Then some information could be gathered on viral load and used clinically the way it isn't today. I think a retrospective examination of pools of data might be very helpful in that regard.

That would be interesting as it segues into what Cameron's group is doing because if you're talking about viral load and quantification, even at different points in the disease severity, that's right in the kind of wheelhouse of epigenetics and nucleosomes. So Cameron, maybe you can talk a little bit about how you see Nu.Q and capturing nucleosomes as a measure of viral load or something that can confirm viral load and the patient progressing or not progressing.

Yes, absolutely. So the level of -- background level of nucleosomes in healthy people is extremely low, and we've seen it in trial after trial after trial. There are levels of different things as we've seen from cancer, but that's, I said, more nucleosomes. So the levels of detection rates in the people with severe SARS and -- which is the immune response to COVID, had been extremely high. So I think there's -- we'll file the data the next 2 weeks, next month. But what we do know now is mostly people have a very, very low and tight range in particular assays. And we've got a few assays that have had very good discrimination. One in place was 100% and one in the mid-80s, so we're putting together some tables now. But I think it's -- what we do know for certain is healthy people have -- and very low symptoms have low levels, and people have a high level when they have a high load. So what we need to see now is the curve in between. But it makes perfect sense when you have a large amount of NETs, which is what comes in, you have a large amount of signal in [indiscernible] so it all makes perfect sense. And the data we've seen now, that the COVID's were extremely high, way higher than, I'd say, anything else, which makes sense there's a huge amount. So we're not getting -- detecting the virus itself. We're getting the immune response to the virus, which is extremely epigenetic, obviously, in the promising and the next. So we'll see, but it makes perfect sense. It would be extremely helpful to have a prognosis as you probably know. And just as a background is COVID -- beyond COVID. So I think I mentioned it briefly, but this is exactly what happens in the modern flu and SARS, acute respiratory -- or severe acute respiratory syndrome.

Understanding viral load and quantifying and maybe there's an immune component to that, right? You're talking about pneumonia and maybe managing your viral load is an issue, and that's going to be different for different people. So Erik, is that something that Saphyr can look at as well? You're not just looking at disease susceptibility, but maybe disease management from an immune perspective? And maybe you can even extend that to who might be responsive to a vaccine.

Yes. I mean we already have some studies underway where we are looking at the MAC region, which modulates the immune response on an individual basis, and the expectation there is that variation is going to drive the host response across the board. In the case of immune response and MAC, it's likely to be a mixture of traditional SNPs but also structural variations. And so that's where a lot of these studies that are combining sequencing and genome mapping with the Saphyr system will start to reveal a complete picture. But again, I think that the testing and diagnostic for the disease is so critically important. And because my mic is unmuted, I will say that as a citizen -- well, as a CEO of Bionano, Mike, we want to test every one of our employees, and we're searching for a lab, so my guys are going to call you right after this panel. But as a citizen, I really am eager to see the country reach the levels that were talked about in that Harvard study. And to me, it seems very doable. My first company developed all the rapid test for MRSA, C. difficile, VRE. BD acquired it. The Cepheid MRSA test is based on the IP that we developed. The technology for doing this is well established and well known. This is a logistical challenge. Admittedly, there are issues with materials such as the collection materials, and kudos to everybody who is expanding the capability to more easily attainable samples. But to me, I'm a little bit blown away that the industry as a whole has not come together effectively and addressed the logistical challenges, put together a structural plan and kind of segmented the levels of testing that are required. And to me, it is fairly clear that regional centers like gyms, like Mike's, are the cornerstone to getting the scale and technology like Dwight's, which is agnostic to the box that's driving it. We have it right here on this panel. And so maybe the remaining step is like the logistics and getting organized, and so I'm hoping that the lab industry groups can come together. But when you want to start talking about -- I mean, that's just the diagnostic test, and that's just the beginning. A vaccine when available is going to be available in a limited supply relative to the need. I'm sure it will be available in a large supply relative to what would be a normal vaccine season. But here, we're talking about, obviously, large-scale populations that need to be vaccinated, and we're not going to be able to address that. And so we're going to need more information to drive the rationing of that technology treatment. And just being able to tell somebody that you've got the disease, go home and you're going to be fine in a couple of weeks is incredibly powerful. And we have an example that we're familiar with in our midst where it's exactly the situation you described, Jason, where there is an individual who got the disease, symptomatic and the spouse never had any symptoms, manifested anything relative to the disease. And this is a story that's being told very commonly. So what is going on there? It's just as valuable to know the underlying drivers of that as it is to know who's positive or who's negative for COVID and so we do that work.

And we can go down that road of geopoliticizing everything and why we ended up here. That's outside the scope of this. We could talk privately off-line while that might be. But I think one thing that might be irrefutable here is that at the end of the day, it's regional governments, regional labs. But what's come to the rescue is the private sector, whether it's LabCorp or Biocept or otherwise. And that's really where testing is doing very well right now, which is a fairly nice example of capitalism kind of at its finest in a time when things really suck. But that being said, there's been speculation or misunderstanding in the space of they're not having enough tests available. PCR is not scalable. And one of the gluts in that pipeline was RNA extraction, Jim. You know very well because you've kind of come up with a solution for that and apply it. Can you talk a little bit about what the challenges were early days of testing, which really wasn't that long ago, but still, you do have a solution for that? You're muted.

Sorry. Thank you. Of course, at the start of the pandemic, the rate-limiting issue was the material required for RNA extraction. It's probably the step in the process where the risk is greatest to the technician who's actually doing the test. And it is time-consuming. In terms of the -- it represents often more time than the assay does itself. So developing methods that allow one to access the viral RNA in -- at high efficiencies without having to go through the extraction is, from our point of view, a priority. And we're making great headway along those lines and are very hopeful that we will be able to include it in an EUA very quickly. I think it could make a big difference to high throughput testing, especially in the reopening scenario where you've got to do frequent retesting of employees perhaps every month, every 2 weeks depending on what they're doing, like the nursing home workers. I think that could be a tremendous help to implementing the kind of throughput that, that requires.

Yes. That's -- the nursing homes are a whole separate issue. I think most people don't understand is that you can't just move a unit of a nursing home to another unit. There's just not enough room. We can't really move them to hospitals so they get stuck in. For lack of a better description, it's almost like an incubator. So testing is going to be a really big deal. Mike, I don't know specifically what RNA extraction you guys are using, but I do know that sample collection is also a major issue. We've heard about the Defense Production Act and the cotton swabs. You guys are familiar, obviously, with oncology sampling because you make your own tests or your kits. And does the same apply for COVID? Can you answer that call, so to speak?

Well, there's 2 answers to that. One is, as Jim alluded to, there's 2 kind of transport medias that the specimen gets shipped in. One is called viral transport media, the other is called universal transport media. And universal transport medium makes the virus noninfective. So it deactivates it, but it still allows plenty of material for analysis. So that's what we're creating here at Biocept, our own version of that to be able to include in our sample collection. That's what's in very short supply. The viral transport media is also in short supply, but a little bit easier to get. And so we've decided to take that into our own hands rather than continue to wait for third-party vendors. For RNA extraction, we're using automated platforms, and that is good. But I think there's always room for improvement. As Jim and Dwight know, I'm fans of all of the guys on the panel. I met them all before. And so I think we're at the beginning of this. And one of the things you asked about earlier and wanted to hit on again, Jason, was capacity. And I don't know if you saw yesterday, but there was an interesting article that came out in genome or maybe the day before. And what folks are trying to understand is right now, we all have excess capacity for COVID testing, but that's a point in time. What we have to come to grips with, I think, as a nation, is that this isn't about over and we're probably going to have a big swell again in the fall. And so everything we're doing now at Biocept, everything -- everyone here is doing is going to be needed this fall. It's going to be needed next year. Until we find a vaccine, a way to prevent this, we're going to need to test people routinely. So this capacity we're all building is very important because it's got to be there. And it doesn't matter if your LabCorp or Quest. Both are under capacity at this point for testing. And it's what I talked about earlier. I think everybody wants to be tested, or most people, but most people don't know the first thing to do to get it. And so there's lots of ways to be able to get the testing, but you need to make sure that your test is going to be done by a reputable provider. And one of the things that you should always look for when your tests are being done is that it's being done in a CAP and CLIA-accredited facility. So many of these tests that we've read about that have a lot of false negatives, especially more problematic than false positives, are being done with off-the-shelf kits that maybe some well-meaning physician uses and doesn't really understand what they're getting into, and it's giving people distrust in the testing. All of us are examples of people that have dedicated our lives to improving patient outcomes. And we're putting our reputations and our companies behind, putting offerings out there that are reproducible, reliable and you can trust in the results. And that's one of the key things people need to keep an eye on. And I think this is going to play out over the coming months. It's not over the coming days. So a lot of times, I know we're all very impatient. There's a terrible pandemic. We have to do something immediately. We're all working so hard to get things done. But this is going to be needed for months and probably, unfortunately, for the next year or more for all of us. And the last thing I'll say is the numbers are daunting. So I was on the task force call. I think, Jason, the material from it -- from Friday. And they talked about just the people in health care, the first responders, people in health care. Here in the U.S., you're talking well over 100 million tests per year. Think about that. And that's what we really need to get to. So we're all trying to build this capacity. There's these fantastic technologies we're learning about today that are coming out that are going to help us in the future scale that. But we've got a problem this fall that we all have to get ready for, and I think we have to take it seriously.

So let me circle back to Dwight because Jim was talking about the RNA extraction piece as critical, right? If you don't get a good RNA and you don't get enough of it, you're in real big trouble as far as your test quality, right? But Dwight, help people understand what -- how CoPrimer technology kind of fits into that. Because they put out this fantastic paper yesterday or the day before, where they found coronavirus in a tissue biopsy. And that is a milieu of -- you guys can all appreciate how many different things are in there and you can tease out coronavirus with CoPrimers. And maybe you can help us understand a little bit more about that, the sensitivity issue.

You're talking about a paper that's been published in -- out of Milan, Italy, where they had a...

Yes.

A patient that had a tumor in their tongue, and they were able to test the patient before they went into surgery. The patient showed positive, utilizing our technology. The patient was asymptomatic. But knowing that it was positive using our test, they were able to take appropriate precautions. And indeed, within a few days, the patient became symptomatic and was tested again, again showing that they were positive. So the ability of a test to have 100% sensitivity and specificity is important. Now theoretically, nothing is 100%. But in the studies that have been done in numerous different venues around the world on our test, significant studies, they've consistently shown this type of result of the 100% sensitivity and specificity, the 2 benchmarks for accuracy. And so that definitely plays a role. I wanted, Jason, to just step back for a second and say, what we're involved with, with a number of different CLIA labs around the United States is definitely high throughput scenarios. We're talking about labs that are capable of doing many thousands of tests a day on an individual basis. And they're being -- what's happening to laboratories that are big CLIA labs in the United States is they're being asked to do the COVID-19 testing for all of the different constituents that they have around the country. Right now, we're in a situation where someone like Michael Nall is just as good as somebody in New York because it only takes a day to get it to him. And if he's got capacity, he can do the test. And we have labs that are taking tests from all over the United States and in many places of the world that have very high throughput capacity. And they're using -- for sample extraction, they're using what Bill Gates had referred to a few weeks ago in the context of turning agricultural devices that were used to take care of things like corn and able to process samples at a much higher rate, using much less fluid in order to get the result that they need. And of course, having a technology like our CoPrimers helps get that done with very low levels of sample and such to get the actual result. The saliva also, by the way, has been shown in a recent study at Yale University to have greater opportunity than nasopharyngeal or oral swabs, and that's very promising because we can transport saliva very easily. And one of our customers has demonstrated the ability to keep that sample in very good shape for 96 hours, which means you can even obviate the need for a FedEx and in some cases, to get the sample where it needs to get. So I think if we brought all of the infrastructure of the United States health care system to bear here, we can get this job done of getting our 76 million students back to work and our 157 million workers, but it's going to require leveraging all of that. For example, we have 186,000 dental offices in the United States, and everybody knows how to take their child to the dentist. And you could get them back into school initially, simply by taking them to the dentists, they don't have to even sit in the chair. They can take a self-administered test in the lobby and you have those kinds of opportunities that if we leverage the physician offices, the dental offices, I think almost every business in America is developing plans for how they bring, say, 30 employees into their confidence room and say, "Here's your kit. Sometime during today, spit into this jar." I'm using that spit colloquially here but, "Then drop off your test kit at reception on your way home so that tomorrow, we can know whether or not you're going to be there." And we're also seeing large companies that have tens of thousands of employees that are putting together protocols for testing their people. And I want to just share with you because I didn't think this will be interesting to everybody watching. People are coming up with very novel approaches, including the pooling of employees. So for instance, in order to get massive testing done at a facility where you have 10,000 people, you don't necessarily have to do 10,000 tests. You could do a pooling of 10 tests at a time. And then if there's any infection in those 10 people, it will show up. And then you can test all 10 of them or you can do it in a group of 3 or whatever. But there's going to be all kinds of different constructs developed as people decide how they're going to keep their business open, how they're going to keep their schools open, what are we going to do when little Sally sneezes in fourth grade...

Right. That's a whole lot -- we're going to get to that in a second of where we go with testing. I wanted to go back to Cameron and Erik for a second because there is this issue of susceptibility. There's this issue of quantifying if maybe quantification is related to being symptomatic. It probably is, degree of virus shedding. So are there opportunities for Volition and/or Bionano to partner up with these labs to start putting the acute testing in there? Erik, you have Saphyrs placed already all over the country and the world. How are they -- where is the opportunity here for you guys to be incorporated into this testing process? Let's start with Cameron. Go ahead -- or either way.

Yes. Thanks. So the benefit of all the work we've done over the last, I think, few years and making a very robust, reproducible ELISA-based system is it can be done on plates. It's on magnetic beads now. So we've brought it to our own solutions, but it can be adapted to all the big order analyzers, all the big companies. I'm sure you know Roche, Abbott, Siemens and being a single assay. Now that we've observed the antibodies under control, which I think we talked about quite a lot in our calls, which is a recombinant control, it's incredibly robust, reliable reproducible. So it can be done in the most simple format, which is the plates, pretty much any auto analyzer. So our aim at Volition has always been to launch the products as quickly as possible, as widely as possible and get it out there because the cost of goods is antibodies under control. So it's very good value to the manufacturer, keep it low cost and really get it out there a lot. So if the trials over the next month, 1.5 months go very, very well or as well as we expect, I think we can launch products quickly in rated labs. And we're not trying to -- we're not going to have a large sales force. We're not going to have a large lab ourselves. We intend to license it, particularly for COVID given the pandemic. And also -- but I think given the price point, and the American market is obviously incredibly important, but we have a footprint in Asia and Europe. I think it's something which could be useful for billions of people worldwide because this is a problem everywhere. And just to emphasize the difference, testing is incredibly important, as all the panelists have said, and knowing who really needs the attention and who can go home and self-isolate. I think some of the issues during this crisis have been too many people being in the hospital infecting kind of each other and clogging up the system, which is understandable. If there's not a prognostic, you don't want to send someone home and then to be in trouble in 24 hours' time or 12 hours' time. It would be a tragedy. So a good prognostic market would certainly help with the load it has on the health care system and on medical staff, and it should be very interesting. But the short answer to the question is it could be used -- provided very quickly.

Right. And Erik, because you are in a position, Bionano as a company, where you're scalable, right, because your chips -- or having more samples for chips and you're on your way almost exponentially up, could you see a scenario where a patient comes into an ER or a large like a Mayo Clinic or something like that with symptoms of coronavirus? Or maybe now they're going to get a structural variation test to see how susceptible they are and maybe where they can progress to?

Yes. So for sure, I think that the Saphyr system is the type of platform that fits in a cytogenetics environment. The workflow is going to take a couple of days to get to the types of results that people need. But if you're collecting the sample at the point of care, like you've described, the results will be available in a time frame that allows you to prescribe all sorts of interventions and patient management scenarios. And what we're doing right now is leveraging the roughly 100-or-so systems that are installed worldwide, but in major markets, Europe, North America and several in China. And we have put a call to action out to all of those Saphyr owners, and it's to be on the ready to start running these samples because the only way to get to these prognostic markers, which are so far undiscovered, right, they -- secrets are definitely there in the samples, but the markers are yet undiscovered. So the only way to reveal them is to start running these patient samples. And so we have that effort to basically unite the entire installed base of Saphyr systems as a network that's ready to analyze patient samples that can be coming from their own global network to drive a large volume of sample analysis. As Jim mentioned, the deep bioinformatic analysis that's going to go along with that. And why not have the end goal be that the systems that are on their way into hospitals for cancer testing and other forms of analysis be there and be used for patient stratification in COVID.

And your data accumulation and bioinformatics is a real interesting point because, Mike, you have a very interesting relationship with the company that does bioinformatics. It's all about bioinformatics on oncology like what Guardant is doing, some of the other bigger, larger players. But is there a bioinformatics opportunity for you because you're going to do a lot of COVID testing soon?

Well, there could be. And there's 2 ways to look at it. One is what comes out and when comes -- what comes in. And so there's opportunities on both sides to better triage both the tracing of the patients as well as identifying upfront what risk factors are present to better predict how the test results can predict patient outcomes, which is critical in this. And knowing who we need to intervene immediately, who can be more safely watchful weighted, et cetera. And so I think there's a ton of opportunity there, and we're just at the beginning of assessing how that all fits together. But it's not dissimilar to HIV and some of the other pandemics or epidemics we faced, where you need to first test to see who has it, but then you need to monitor folks to see how long it's in them and what the viral load is in these cases we've heard about today. These are all important opportunities, and it means multiple tests along the way and testing in a monitoring basis over and over. But just like you said, it's kind of our same story about liquid biopsy as well in cancer. It is the need to monitor more and more.

So I want to ask a very broad question. It's kind of open to everybody. I'll throw it to Jim first. And I was kicking this around over the holiday weekend. It's a very nice weekend in New York, by the way. I know you guys are in some sunnier areas in the year. Testing has been a bit of a double-edged type of sword thing, if you want to use that metaphor. Where we needed it, we didn't have enough of it. Now we got so much of it. Everything is under capacity. You're being underutilized. Now saliva testing is coming, right? And because -- as Dwight had mentioned that, we have too much testing. What happens now? Because humans, especially Americans, hit the panic button very quickly. And if you're going to saliva test Sally, to Dwight's point, at school and she tests positive, do they shut the school down? We have so much testing. We have -- we got what we asked for, but now do we want it? If you look for MRSA, you'll find it everywhere, pick your flavor of disease, it's on everybody. We're passing things constantly to each other. So Jim, what do you think about that?

I would only agree that we have too much testing if the day ever came when we had too much information, and we certainly don't have enough information right now. So in my opinion, the more testing, the better. We really need to understand viral load and the progress of the disease, the viral load and the comorbidities, the viral load and the likelihood of infection and maybe that will be related to some of the other issues we've heard from other panel members here. So that means making the test easy for a patient to comply with. You can't have reluctant patients pinned against the wall with an NP swab. They don't come back the second time. And I think that making it easier, making it more quantitative, extracting the value from quantitative PCR, understanding how that relates to the evolution of the disease in various patients, and maybe that changes with structural variance as well. We'll have to -- I think we need more information, more analysis.

Well, it underscores the -- what Bionano is doing. We don't know. We need to know, right? So getting information is going to be critical. Dwight, I want to ask you specifically. Do you think the days of -- because your group does multiplex testing already for infectious diseases just based on the technology that you have. It works. Are the days of going to your doctor with flu-like symptoms and just getting a flu test over? Are you now going and you're getting a coronavirus test and a flu test and maybe a few other things in there? Is that where we're heading?

My view, Jason, is that it's no longer going to be cold and flu season. It's going to be cold, flu and COVID-19 season, and I think that's just axiomatic. I want to take a little bit of issue with the statement that there's a surplus of tests available. Our company has been involved -- we got -- we were the first U.S. company to have a test that was -- received a CE marking. And since then, we've been manufacturing and shipping tests around the world. We've had to amp up from the ability to do 50,000 test manufacturer today to doing 1 million a day to doing -- to where we now have the capacity. And I stress the word capacity to do in the neighborhood of 3 million tests per week. And I'm -- let me say that 50,000 tests a day to 3 million per week is a big jump, and that's utilizing our Salt Lake City facility, our India facility through a joint venture that we have there. And we've also engaged Promega in Madison, Wisconsin, which is a great firm that manufactures tests for us. So we've had to amp up continually to meet demand throughout the world in what is just, in some places, just beginning. If you've been watching the news, you can see what's going on in Brazil. You can see what's going on in Mexico. And we monitor on a regular basis the number of tests that have been performed in every country in the world and the percentage that, that represents of their population. And until this disease gets 60% to 70% of the people on this planet infected, this disease is going to continue to take casualties. And so we think that the necessity for additional tests is going to be enormous. And we are going to have to leverage the whole infrastructure of our health system and our business infrastructure and such to get it where it needs to be. And it's not just in the U.S. It's all over the world. So we're working hard to meet demand, and we've had to continually amp up in order to meet demand. And I think that that's where we're headed. And if we're headed for anything like what the Harvard University is suggesting, where we have to do a 5 million a day and as many as 20 million a day, we got a long way to go before we've got saturation of availability and tests.

Right. And you'd mentioned -- I think you were referring to infectivity rate like herd immunity. I know people keep talking about it. The media likes to talk about herd immunity, but that's another double-edged thing. If we didn't know anything about coronavirus, we had to isolate people, we had to do this. Now yes, we're 20% infected. We need to be 80% to 90%, but you can't try to have it both ways. So testing is going to have to be here. And also, Cameron, for you, because what they don't know is that, that drop of blood test, check the box with Nu.Q for oncology could be alongside your cold, flu and COVID testing, to Dwight's point, when you go to the doctor, yes?

Absolutely. So yes, in testing, I think probably what's going to happen, I agree with all the panels, what we've said. It's probably a flight to quality as well. I think we don't need more testing. What we need is a more accurate testing. Testing can be counterproductive if it's inaccurate. So getting a higher level of testing, better modalities is probably where it's all going and very much needed, but I totally agree. But don't forget what we detect -- it's not actually detecting the virus. It's detecting the immune response to the virus. So as far as if the data is good over the next month or 2, we're not detecting COVID, we're detecting the response to that response. The NETs, which I think you'll hear a lot more about, is actually what kills you, is exactly the same in pneumonia, in flu, in COVID, in other coronaviruses and a range of other things. So epigenetics are incredibly important in cancer. And in a lot of other diseases, we'll see how it grows with NETs now. But I think if the screening, as we talked about in cancer, is very important and a low-cost, really highly compliant test is incredibly important. Therefore, a blood test and routine blood test. And a routine blood test for NETs, which is the immune response, which is what kills you. If it's prognostic, that's incredibly valuable. And that would be something which -- I think there's 800,000 people hospitalized with flu or pneumonia over the year in the U.S. as well so it's something which could be very widely given. Just to be clear, that's the same test for COVID as it is for pneumonia. So I think the NETs and the SARS component of this that's actually what kills you has got a lot of legs to go. And it would go all the way through even after this pandemic is through, the modern flu.

It's going to be interesting -- because we're coming up on time. It's going to be interesting how this plays out for all of you and also the space because you guys remember Ebola and what the space went through -- the biotech space went through. It kind of spiked and then it kind of came back down. Coronavirus is just not going away. It's pretty clear at this point. And this is now becoming, or at least presents the idea for investors thinking about these companies, this is a long-term opportunity for all of you. It could be Biocept. You had mentioned earlier, Mike, the offsetting revenue. COVID could be a whole new business. Same thing for Jim. Dwight, you're already there, clearly. And even in Bionano from Saphyr adoption, and Nu.Q is moving forward for oncology, but now brings it to the table for -- at the bed side when you're at your doctor's office. So there's tremendous opportunity. I think it's a long-term opportunity for everybody. Didn't see this even a month ago, but here we are today. Before we leave, though, I wanted to take a moment to let each of you just close for a minute or 2 on each of your companies and where you are and just leave investors and viewers of what you're working on. So I'm just going in order of what I see. I see Erik on the -- right in front of me right now. So we'll start with Erik to find out.

Well, sure. So thank you, Jason and the panelists. It's been a great discussion, and I've actually learned quite a bit here. And I think as far as Bionano goes, this has been a challenging period for us, and we sell primarily into the academic research market for clinical research and we're beginning to see adoption in a clinical setting to replace traditional cytogenetics methods. But the current situation has disrupted that quite a bit. COVID as a research topic has come along and really created a significant opportunity for us. And our end users who had been researchers in one disease area or another recognized the same opportunity, if you want to call it that, but it's also a calling. We now feel like it's more important to understand disease susceptibility in patients where COVID is concerned as opposed to maybe some type of cancer variation or something like that. And so interestingly, in Bionano's favor, but I think in support of so many, there's going to be a shift across academic research and clinical applications that's shaped by COVID going forward. And Bionano is excited to be a part of it, and it feels like it can make a very important contribution. So thank you for letting us talk about it.

Thank you, Erik. Mike?

Yes. Thank you very much, Jason, and great to see you guys again. I think there's tons of opportunity for us with the companies here, hopefully, as a CLIA and CAP-accredited laboratory, but also as a supplier. I've seen some of the Q&A that's coming down on the questions from the folks that are -- have attended this great event today. And one of the questions for Biocept was, well, what are the milestones to watch for? What are the next announcements? So I think sometime in the next month in June, we'll have an announcement on our collection kits. And we want to be able to take that in the same way we've taken our other assays we've developed here at Biocept and move that into something that can be sold to others. So we look at this as a way to help folks ongoing. This isn't just for the summer or a point in time. I agree with everybody here. This is a challenge that we've got to face head on. We've got to face it and plan for a long fight, unfortunately. So this means that there's going to be a lot of evolution between what we offer today and what we may be offering 6 months from now and what we may be offering 9 months from now. And that's the nice thing about having your own laboratory facility here as well as technology and IP. It is that we can put it to work right away. And that's what we've done in oncology. That's what we're going to be doing with COVID testing as well. So I look forward to another one of these in a few months when we all give an update on where things are now and hopefully, we'll all just be like Dwight and see the same things happen with us. So thanks, everybody, and great to see you.

Dr. Hayward?

So the ultimate R&E for us is we've spent the last 10 years preparing large-scale PCR for a variety of applications from industrial applications to health care in diagnostics, in vaccines. And we were just perfectly positioned to be able to respond very quickly to the coming pandemic and once it was here, to deploy as much as we could, as quickly as we could. So we're grateful for the tolerance our investors have shown in our progress and for the support they've shown as we pivoted. And clearly, I think we're in a position to do good and to do well.

Dwight?

Thank you. It's been fascinating for me to hear about the developments from all of the panel participants today. And in summarizing Co-Diagnostics position with respect to COVID-19, we're in the business right now of expanding our territories of distribution. We have about 50 distributors around the world that cover over 100 countries, and we have distribution into about 50 of those countries now and look to continue to open up new territories and markets for our test. We're involved in a lyophilization situation right now, where we can send these tests without having to worry about a cold chain that's forthcoming for our company. And we're excited to be able to not have to worry about that prospectively. We're also developing, as I mentioned, new test initiatives that are innovations that have to do with both the viral and antibody in a single test and another test that differentiates from other flus and upper respiratory diseases and also the mutation aspect that's going on. And so we're looking to create a product and a line of distributors and customers that have durability and continuity as this virus takes hold and continues to work its way throughout the worldwide population now and in the future. As a final comment, Jason, I would say that in watching the news over the weekend and seeing what's happening as these states and cities are opening up, we're approaching this in a very cavalier way as a country and in these communities that looks to me like there's not very good social distancing going on. Big groups of people are getting together. We need to be careful as a society that we don't give this little virus too much of a chance because it will take -- it will be successful in infecting us. And so we need to make sure that as well as our testing initiatives and other things that, as a society, we're paying attention to what our expert health care professionals are telling us we need to do to protect ourselves and our loved ones.

Yes. I think one takeaway we can get from that and reopening, we've learned a lot as a society in the last 3 months, call it, 2.5 months, and we'll see where it goes. But I think we're -- certainly because a lot of people like you and meet your companies, we're in much better shape now than we were in January. So with that, Cameron, kind of take us home on where Volition is, and we'll take it from there.

Yes. Thank you. Thank you, Jason, and thanks, Maxim, for organizing this. I guess this is the new normal. We're going to have to get used to conferences and the way it goes. And yes, I think I'd like to reflect the rest of the panel. It's been very interesting. And hopefully, it's been interesting for the participants. So Volition, yes, we've been working in Rx. We've been working for a long time now, I guess, like the other panel members. It's -- we've developed an incredibly stable, reproducible, robust platform now, which can detect epigenetic signals in plasma and other bodily fluids. We've shown fantastic data in a few different cancers. We believe not only is epigenetics very important, but a low-cost, easy-to-use, robust platform, ELISA-based that can be done anywhere in the world that takes costs out of the health care system around more expensive test kits. Every health care in the world system is struggling, even the U.S. now, which money is becoming, obviously, more important as things get more expensive. Having a truly robust routine test is incredibly important. And in the COVID space, this is what we've really been hoping for, for a long time. What we've developed for the cancer space, detecting the [ protein components ] and we think -- and find out in the next month. We use it in a wide range of areas and we'll see how it is in COVID as a prognostic. So we'll have a lot of data from all the other work we're doing. It's exactly the same platform, measures the same structures, just different -- we can measure hundreds of different structures in everything. So a very incredible, big, robust platform. Epigenetics now has certainly become mainstream. When we started, it was very much on the fringe, and we've developed the platform. We really dominate circulating nucleosomes, and I think it's going to be a fantastic year for us. So everyone out there listening, please listen in to our data over the next 1.5 months. If we can show prognostic value, I think it's going to be extremely important in the COVID pandemic and extremely important going forward, be it pneumonia and flu and something else. Hopefully, a lot of people on the panel -- and this month, we'll be using a lot of Nu.Q tests in the future in a range of areas beginning with cancer, hopefully COVID and even there on both sides of the leash with the [indiscernible] as well because we all have the same protein component. It's going to be a very exciting year, and thank you for this opportunity.

Perfect. With that, we're up on time. I want to thank all of our panelists and attendees for another tremendous event. There's great people behind M-Vest that put this together. Very technical. And for making this a really unique and exciting experience. Yet again, M-Vest is an emerging -- it's really a tremendous platform that Maxim has. This is our second in the series of COVID and infectious disease, but that's just one vertical. Anthony, who you heard from earlier, and I, we have a tremendous health care platform here at Maxim's. A lot more biotech and health care to talk about, so we will see you again soon. We've got a lot of ideas. So thank you, everyone. And again, please stay safe out there.

Thank you. Have a good night.

Thank you. Thank you, everyone, for attending. We appreciate it.