bioAffinity Technologies, Inc. (BIAF) Earnings Call Transcript & Summary

Good evening, and welcome, everyone, to tonight's webinar event. Before we begin, just a few reminders to anyone who is new to the webinar. [Operator Instructions] We would like to thank CyPath Lung for sponsoring this webinar and 2026 SAB sponsors. At this time, I will hand it over to Dr. Sussman, who will be moderating tonight's session. Thank you for joining.

Thank you, and good evening, everybody. Thanks for joining us for this program. And I'd especially like to thank the Society for Advanced Bronchoscopy for hosting this webinar. We're very lucky today we have an excellent multidisciplinary panel, including an interventional pulmonologist, a thoracic surgeon and an oncologist who are really at the forefront of diagnosis and treatment of lung cancer. My name is Robert Sussman. I'll be your moderator for today's program. I practiced pulmonary for 37 years at Atlantic Health System in Summit, New Jersey. I recently retired from clinical practice. During my time in practice, I also was the Medical Director of the Atlantic Health System Pulmonary Clinical Research Center. That's where I first became aware and involved with CyPath Lung testing, which is what we're here to talk about today. I was a principal investigator in several of their trials and a co-author on 2 of their papers. Tonight, we'll discuss how this noninvasive test can really be used to help stratify indeterminate lung nodules. You'll hear how this test can be used to give you greater precision in risk stratification and diagnosis. Let me just ask the panel to introduce themselves and their practices. Dr. Guda, we will start with you. You're an interventional pulmonologist. You've had a lot of experience with diagnosis of lung cancer. Why don't you tell us a little bit about yourself and your practice?

Thank you so much, Dr. Sussman, and honestly, the Society for allowing me this opportunity to speak. My -- as my name has already popped up there, it's Dr. Guda. I'm an interventional pulmonologist, trained out of Lahey, and I currently practice in Texas. We have a broad reach of patients in the broader DFW area. We have at least 3 clinics at this point that are essentially dedicated towards lung cancer. We have a very large swath of patient population that are suffering from cancer and all the manifestations of late-stage disease and early-stage disease. And ultimately, our goal is to stage shift the community, which comes from early detection.

Thank you. And Dr. Baptiste is a thoracic surgeon. As we know, in general, thoracic surgeons see patients after they've already been diagnosed. Dr. Baptiste, I think, will tell us a little later on that there are exceptions to that when patients haven't been diagnosed. But why don't you start off by just telling us a little bit about yourself and your practice?

Sure. I've been in practice for going on almost 29 years. I trained in San Antonio at Health Science Center back in the '90s. My practice is really about 50% cardiac and 50% thoracic with a little bit more interest in thoracic as the years go by. But I work primarily in a community hospital in East Texas, Texarkana. So CyPath has been very welcome to me as a practitioner for another tool in the toolbox in regards to what to do with these nodules that are found serendipitously and in high-risk patients. And in the area that I live in, there's a dearth of pulmonologists, there's a dearth of everything. So the more information I can get with the patient with the lung nodule, the better and the happier I am with thinking about a management plan.

Thank you. And last but not least, Dr. Gunuganti, who is an oncologist, again, typically seeing patients after the diagnosis has been made, although there are some exceptions. Why don't you tell us a little bit about yourself and your practice?

Thank you very much for the Society and Dr. Sussman to be part of this panel. I'm a medical oncologist with a special interest in lung cancer and I've been in practice for 21 years with Texas Oncology, which is a very big group in Texas and recently launched an incidental nodule clinic as well as low-dose CT scan project with local [indiscernible] hospital group and also at Texas Oncology, we have scanners in every clinic. We are doing more benign hematology, trying to do low-dose CT scan for high-risk patients.

Thank you. So as we all know, things are rapidly changing in the field of lung cancer diagnosis as well as treatment. And I think everybody on today's program knows that better than anyone. And I'm going to date myself now, but when I started in practice and especially when I trained, we didn't have a problem with lung nodules. They really weren't an issue for us. And the reason was in 1985, when I started my fellowship, we rarely did CT scans. They were -- they existed. They were used for neurological purposes. They were starting to be used for belly. But to convince the radiologists, and at the time, the Head of CT Radiology at Bellevue was Dave Naidich, who many of you may know, one of the world's experts on lung nodules and CT scans, we'd have to beg him to get a CT scan. So we really dealt with lung masses back then and not lung nodules. But as you all know, things have changed. It took another decade or 2 until we had PET scans, longer than that until we had low-dose screening CT scans. But now you guys have all kinds of new technology, robotic bronchoscopy and you can go after smaller and smaller nodules. And if you look back even as far back as 2022, there's a paper that said estimated 1.6 million nodules in this country each year. And that number is going up. It's going up astronomically. And the challenge here is how do we restratify? How do we know which nodules require intervention and which nodules just require watching. We know we have risk stratification tools. We also know that they're not very good, Mayo, Brock. Many times, we use physician gestalt, which is as good or better. And it's that uncertainty in risk stratification that really brings us here today. So we want to tell you a little bit more about CyPath Lung, again, a noninvasive test that can add greater precision and success in risk stratification and determining who we go after. So if you can put up the first slide, I just want to give you a little brief overview of CyPath. Again, I've mentioned before, it's a noninvasive test. It uses flow cytometry along with a computer AI-generated machine learning algorithm. It looks at 3 things from the sputum standpoint. It is not cytology. It's a common misconception that flow cytometry and cytology are the same. They're very different. But it looks at 3 things really. It looks at -- it does porphyrin staining to look at cancer cells and cancer-related cells. It uses antibodies to identify cells in the microenvironment because we know that the microenvironment is very important, especially in the early pathogenesis of lung cancer. And it looks at apoptotic populations. And by looking at those 3, again, using machine learning, AI, it comes up with a -- what is really a binary result, either likely lung cancer or unlikely lung cancer. And I should mention that this is a test that's done in the patient's home that collect sputum using an Acapella valve to induce sputum almost all patients that we screen can produce sputum. There is an online coach if they need it, and most will utilize that in order to effectively use the Acapella valve and produce sputum. And then they FedEx it directly from their house to the lab. So early detection is really important, but let me ask Dr. Gunuganti to discuss advances in treatment.

Great. So traditionally, what lung cancers we used to see out of 0.25 million lung cancers diagnosed each year. Lung cancer is the highest killer of all cancers, like 150,000 deaths per year, which is combined deaths from top 3 cancers to breast cancer, colon cancer and prostate cancer. So the highest, biggest killer of all cancers is lung cancer. And we are -- most of them were getting diagnosed, 3/4 of these cases were diagnosed at Stage 3 advanced or Stage 4. Now with the low-dose CT scan incidental nodule programs, we are diagnosing early on. And we also had made a big difference in lung cancer. Before we used to say, okay, even if I treat it, diagnose them early, can I make them -- cure them or make them live longer. Now we have some chemo-immunotherapies we use for Stage 2 -- Stage 1b, 2 and 3 stages where when we use chemotherapy and immunotherapy, there's a complete disappearance of cancer in 25% of patients, what we call a complete pathological response when the surgeon goes in, there's no evidence of cancer in 1 in 4 patients of Stage 1 to 3 when we give chemo-immunotherapy for 4 cycles and then surgery followed by immunotherapy. So these are the big advances in. Before we never had -- 5 years before, we didn't have great treatment. If you still treat early, we were doing chemo-radiation. We were doing chemotherapy. And then still -- the cancer is still there. We were not curing so many people. Now we are able to cure people at earlier diagnosis of cancer. So the onus is, we need to have better tools to diagnose them early. That's when the low-dose CT scan approval came, which was the biggest thing screener. We are not screening them as much as we need to. Mammograms is like 60% to 70%, colonoscopy is like 45% to 55%. And I heard the last number on lung screening is around like teens. So we needed to do a better job. And then in oncology, we also have risk stratification. So everybody goes on with a clinical suspicion, but nobody goes -- nobody is using a genomic suspicion. So in clinical suspicion, we have been doing in oncology forever. If I see a cancer, size matters, shape matters, lymph node status matters. That's all clinical. But where do we come in the genomic signal? We have done so many advances in oncology looking at the genomic signature, whether I should treat or not treat, whether I should give more treatment or less treatment. That has translated with CyPath now where we are applying a genomic signature to tell whether the nodule is malignant versus not. So this is a noninvasive test. I think we really, in oncology, like this because we can diagnose them, find the cancers early, stage them early and then probably cure them early.

That is certainly the goal. If we could just go back to the last slide for a minute. I actually forgot to -- I apologize, I forgot to address it when I spoke a minute ago, I had the slide out, but let me just -- I think it's very important that we take a look at that because I mentioned this as a test that helps you risk stratify. But I think it's important that you see the outcome of the clinical trials on this test. Since -- and we're looking specifically here at lung nodules less than 20 millimeters in size, which is really what you're interested in. Lung nodules 3 and 4 centimeters, will get biopsied, no matter what, but it's the small nodules. So sensitivity, 92%, specificity, 87%, accuracy, 88%, area under the curve, really a very important number, often not looked at that much, but a very important number, 94%. Negative predictive value, 99%, which is excellent for a screening test, positive predictive value, 44%. Okay. So next, I'd like to go to Dr. Guda. I mentioned earlier about the number of lung nodules that are estimated 1.6 million, but going up, and it's going to go up astronomically. We will have 2 million, 3 million in the very near future, combination of aging population, more uptake of low-dose CT screening, more CT scans for every reason, especially calcium scoring CT scans, which is where we pick up a lot of our lung nodules and data mining of EMRs, which are picking up a lot of lung nodules. So that's just increasing the burden on pulmonologists' practices, especially advanced bronchoscopists and interventional pulmonologists. So Dr. Guda, I'd like you to address some of those challenges in the context of your practice.

So you have actually summarized a lot of what's happening in the current day. Patient walks into the ER, the patient gets a CT scan. And usually, it's an abnormal CT, abnormal CT scan of the chest. Patient goes to the primary care physician, the patient is getting a CT scan of the chest. I think a lot of that has to do with increased awareness, which is a good thing because like Dr. Gunuganti said, we want to catch cancer early, we are going for cure, right? And the work that doctors like Dr. Baptiste and all the other CT surgeons in the community are doing is they're going to do surgical resection because they're going for cure. The idea that you want to capture cancers early is in the minds of every single advanced bronchoscopist and interventional pulmonologist that's here. You're performing robotic bronchoscopies, you're performing EBUS. You are staging the mediastinum. You have a CT scan that tells you the size, whatever it may be. And as Dr. Gunuganti has said, you have clinical staging, but a lot of it is coming from an increased amount of awareness that is being caught by knowledgeable ED physicians, knowledgeable lung nodule programs around the country, increased awareness of lung nodule navigators and coordinators, increased presence of a lot of these optimized AI platforms that are able to pick out the report and say, "Hey, nodule, lung, send them to a navigator of that sort." And then general awareness of pulmonologists and primary care physicians that are seeing nodules. So there's a lot of awareness. And we look at all of this in a couple of different ways. We look at them as those patients -- those -- and every single program is different. Our program is very much dependent on oncologists and a lot of the patients that do come to us come from an oncologist. So the clinical gestalt that you're talking about has already been addressed by the oncologists. So the pre-risk stratification of this -- the probability of this nodule that I'm -- that's coming to my clinic of this being malignant is much higher, either because they have already had a solid organ tumor before or they are at risk for developing lung cancer. So you're seeing -- in our program, we see a larger population of patients that are coming in with a higher pre-risk probability. And then you have those clinics where you are living in a very large area of like fungal infections or you have a lot more granulomatous disease. And then you're seeing a lot of what I would like to call it, term it as junk nodules, trademarks still pending. But trying to figure out like those nodules that are present today are gone tomorrow and day after tomorrow, they're going to be back again, how do you approach those nodules in patients that are smokers, in patients that have a high -- probably a high Mayo risk probability, how do you approach those patients? So as increased awareness, increased automation of capture of nodules, increased conversation amongst ED physicians and hospitals and oncologists, offices are undertaken and when you have a large swath of area where you have a lot of these patients being sent to pulmonologist, I'm never going to say no to a patient that's coming in with a nodule. Because if this is early-stage cancer, well, we have caught it, we have treated it and the patient is now cured, right? And like Dr. Gunuganti said, the mortality associated with lung cancer that is at later stages that is unable to get cured is very high. So I'm not going to say no to a nodule, but having a platform that can help me risk stratify them, especially in those that have already had some degree of solid organ tumor that has also been cured or is an active cancer, like that really is helpful in, one, convincing myself that I needed to perform this biopsy; and two, convincing the patient, hey, this -- even though it's a small nodule, it's important that we pursue this and perform a biopsy. The advent of access is another thing that we need to consider because at the time of the Fleischner criteria and everything -- every other criteria that we look at, which are the actionable nodules. The term actionable nodule gets thrown around quite a bit, it changes from practice to practice. Some individuals are comfortable going after nodules that are 2 centimeters and above. Others are more comfortable with nodules that are 6 millimeters and above. In our practice, we look at everything that is -- all the nodules as they come, we talk about them, we discuss them, we have a tumor board and we go forward with pursuing biopsy. Access to those nodules is something that we have to also consider. Access to tools to perform biopsies is something we need to consider as well. And when we look at practices that may not have the latest and greatest or may not have providers that can go after some of these more complex or these smaller nodules. Having risk stratification tools will help them understand, "Hey, this is a patient that probably needs to go to a center that can actually perform this or actually even though it's a 2-centimeter lesion, I'm not as worried about it because I can risk stratify them down. I can just pursue with the CT scan every 3 to 6 months and see if it grows and look at other parameters for helping identify risk stratification." So these are all things that kind of go into appropriately risk stratifying all the nodules that come through your clinic. However, in my personal clinic, because I see a larger amount of patients coming from oncology, many oncologists, like Dr. Gunuganti will agree, want tissue because that's where the issue is. So I will pursue a biopsy. But if I am less suspicious, then I need risk stratification. I need to convince my oncologists, "Hey, I don't think this is something that we need to pursue right now. I need to be able to identify something that gives me a good negative predictive value test." And this is one of those that actually does that.

I just want to ask you one question, have you addressed one issue. You mentioned lung cancer or other solid tumors. Just for the benefit of our audience, can you explain why you mentioned other solid tumors?

Right. Because a lot of the tests that are there out in the community right now for risk stratification, they exclude patients that already have other solid tumors. And this was one of the few tests that they actually included those patient populations to see if there is any degree of negative predictive value in the results. And this is actually is -- even if the patient already has other solid tumors as a history or they're having some degree of active cancer, but it's in a smaller containment at a lower stage, you can still run the specific test for you to assess if the -- and see the negative predictive value is still comparable, whether they have a history of solid organ tumors or if they don't. So it's still -- it does not exclude them compared to some of the other tests that are there in the community.

And taking that even one step further, this test will actually pick up nodules in the lung that are metastatic disease, it will pick those up. It is not specific for lung cancer. It is telling you if there is cancer in the lung or not cancer in the lung. So it can be used either way. If your suspicion is this is not lung cancer, this is metastatic or that's what you're asked to work up. It's still a very useful test. Okay. Let's move on. Dr. Baptiste, tell us a little bit about how this changing landscape is affecting your practice.

Yes. So 2 years ago, Dr. Gordon Downie, the pulmonologist, who was one of my referring pulmonologists in Mount Pleasant. Mount Pleasant is about 1 hour, 1.5 hours away from Dallas. And this whole area, this corridor of Texarkana, we're about 2 hours away from Dallas and 2.5 hours from Little Rock. So we're kind of -- in a kind of a desert as far as medicine is concerned and having a lot of clinicians, we don't have enough pulmonologists. So I'm sort of at a loss for trying to deal with patients that come to me in my lung nodule clinic what to do with. Because most patients, as you guys know, they find out they got a spot in their lung, they want it out. They're scared they have lung cancer. And if it's lung cancer, it's probably early, so let's get it out. So my job is to reassure them that most of the time, the vast majority of those spots are going to be negative and let's just kind of hold the horses and I have to police myself. So CyPath has been very helpful, and I like the binary options as far as the test result. It's either likely or unlikely. There's no in between. So it's very helpful for me for that extra objective data to talk to patients and have a real informed decision on what to do with that 0.8 centimeter or 1.1 centimeter lung nodule. And it's very helpful for patients to have that type of closure as far as objective data to talk about where to move forward. So in an area where there's not as many people to do navigational bronchoscopy. We're starting to use Ion. We're starting to use Cytalux, but there's all these toys. But right now, this is a paradigm that's different than all others. I kind of think of it as a Cologuard for colon cancer in which patients give a sample at home. It's convenient, it's easy, it's private. This is very similar in that regard. And I think it's going to really be very helpful and have a niche for a lot of these patients that want to do something quickly and have some confirmation. And the negative predictive value is very, very key. I think that -- I think Dr. Sussman, you really highlighted that important piece of data.

Certainly, for a screening test, that's what you want. Now I know you made a very good point, Dr. Baptiste, but that -- there are lots of places in the country where there's no availability of advanced bronchoscopic techniques. But I think even when there are, we know there are some cases that just can't be diagnosed. And you're still -- I know I did, and I'm sure many people on this webinar have patients that they sometimes have to refer to a thoracic surgeon with a high suspicion but no tissue diagnosis. And I think you have a few cases, especially one that you want to highlight in that regard.

Yes. It's not a failure to refer to thoracic surgery. Let me state that emphatically right now.

If we could have the next slide.

Yes, the next slide. So this particular patient, it's a very good patient, 80-year-old lady who quit smoking in 1999. She had COVID during 2021, had a previous stroke, hypertension. Overall, she's good performance status, has symptoms of cough, asthma, shortness of breath. Her initial chest x-ray showed a lobulated opacity in the right lower lobe that Dr. Downie took notice of and followed very closely. And she had a number of tests, low-dose CT scan in 10/23, she had a PET scan, which showed an SUV of 2.5. The lung probability was calculated as 15.9%. And she requested to be followed closely and she had a repeat low-dose CT scan, which showed some -- no changes in the right lower lobe nodule. However, in 2025, there were some changes in the right lower lobe nodule and that was concerning with Dr. Downie. And at that time, he performed a blood serum marker of Nodify test that showed a reduced risk. Her Brock score was 15.9%. Bronchoscopy at that time really didn't show any suspicious activity for malignancy. And in addition, she had a second bronchoscopy about 5 to 6 months later, which again showed no suspicious cells. So he performed a CyPath Lung study and it was likely a malignancy. So he had a long talk with the patient, and she elected to have an excisional biopsy for which we did a robotic resection in 2025 of June and showed an early stage neuroendocrine tumor. So I think this case really kind of swung the pendulum to surgery pretty convincingly after the CyPath study test. And I think that was extremely helpful in that regard.

Very good. Thank you. Dr. Gunuganti, as an oncologist, you will typically be seeing patients after they've been diagnosed, maybe after they've had surgery or maybe they are nonsurgical candidates. I do understand that you're also involved to some extent with lung cancer screening. How has the use of CyPath impacted your practice?

Definitely. As I was mentioning before, look at Paula from January 2024 to 2025, how much anxiety are we -- as clinicians are we 100% sure it's not cancer? We are not. We tell the patient well, does not look like cancer, smell like cancer, walk like cancer. But still we want to do is scan in 3 months or 6 months, gut feel, we go with the gut feeling. I got a clinical information we have. But since CyPath came on that anxiety has much reduced in a lot of my small nodule patients. And I also use it for my oncology patients where we do scans every 3 months to make sure the cancers are not coming back, which Dr. Guda has alluded before, with other cancers when we screen them, we are finding more of these nodules. So when we see a 6-millimeter to 1.2-centimeter mass, which had a diagnosis of lung cancer, breast cancer, kidney cancer, 2 years ago, we are in the gray zone, whether is this the same cancer or is it a new one? In that, it has helped a lot. And also in the screening, I removed that anxiety. The patients are not at anxiety, "Okay, doc, told me there's a nodule. The navigator called me saying that it could be cancer, it could be benign, it could be nothing." So with this test, it has decreased a lot of anxiety in a lot of my patients, even though we are not going to subject you for biopsies, bronchoscopies, at least let me do this test and reassure you. I want to make sure it's negative. Most of the time, the negative predictive value is so high, and it helps me like, okay, I can reduce the anxiety saying that, okay, it's not that suspicious, both clinically and genomically, and I can tell you that we can safely sleep at night. So that has helped. And the second thing is when these patients with patients like Paula come with a 1A stage, first thing to ask is, "Did we catch it early, even in the oncology. What is my prognosis?" Then I say, "Okay, you have a diagnosis, we need to do staging and the treatment options and the step 4 is how does this play a role with your life." At that time, they feel happy that we caught it early, and that's what resonates everything. All their family, friends are saying, did you catch it early, check with your oncologist. So all these things reduce their anxiety, give us answers quicker. And as Dr. Baptiste said, maybe we should like -- in Japan, the incidence of colon cancer or gastric cancer is so high. It's like a drive-through scope. It's more invasive. Here, it is just a sputum test. Hopefully, we can use it like Cologuard in future at some point, yes.

Thank you. Dr. Guda, obviously, you've had the most experience with CyPath of any of us. Why don't you tell us a little bit about that and how it's made a difference, and I think you want to show a case study as well?

Yes. So I think the one thing that I do want to like mention is, either you have a clinic and practice that is for performing biopsies of nodules that are small or challenging or you have a clinic that is relatively more avoidant of those. I mean, there's -- and there's something in between. Our practice, like I said, we have a very large practice of patients that are coming in at a higher risk. So when we risk stratify patients, we are careful about which ones we select. A lot of times, there is limitations to CyPath. The sputum production has to be good and then all of that stuff and some patients are unable to tolerate it, even though we want to get them the right testing. So we have -- but the thing is in our community because we have a lot of tobacco use in Texas, as we know, there are -- there's a lot of ground-glass nodules that we get called in for. And ground-glass nodules is one of those bastions of pulmonary lung disease or lung malignancy, where you want to be accurate when you're performing biopsies for these. And with the advent of the older methodology of forceps or a needle, you're not going to be getting in enough tissue to be able to make a reasonable diagnosis. And usually, it's like atypical cells and atypical cells are quantity not sufficient as oncologists are very familiar with. So now with the advent of cryo biopsies, with robotics, and we are able to do more tissue, get more sampling. However, there's a risk associated with it. There's a risk of pneumothorax, there's a risk of bleeding. So when we consider patients that have got ground-glass nodules to take for this, it's very amorphous, the tissue is very, very light. There's nothing solid for you to like stab into. And I think holding it together, you have to take the right patients for this. You can take a patient that has got really significant lung cancer history or -- in the family and a high risk of smoking for ground-glass nodules. And the next thing you know is all you're doing is you're getting just alveolar tissue. But in this one situation, we had this patient who had ground-glass nodules, you can pull up the slide. We changed her name for the sake of anonymity, but this patient, Helen, she had this like ground glass, maybe part solid, hard to tell, that had been kind of -- she had -- a former smoker, she quit about 5 years ago, but she had a significant smoking history. She had quite a bit of anxiety associated with this nodule. Her brother died of lung cancer. Her father and mother both died of lung cancer. They were coal miners. She was a smoker. So there was quite a bit of anxiety associated with this. And this was one of the initial times when CyPath had just started making its way into the community. And I was a skeptic which is a good thing to be when you have new technology coming in. And as a skeptic, I subjected the test to the patient. Not the patient to the test, but the test to the patient, and it came back as a high probability of malignancy. It's negative predict -- but I was more interested in the negative predictive value. And we went ahead and discussed that with the patient. She was obviously anxious about it. So we went ahead and performed the biopsy and it came back as adenocarcinoma and we ended up going -- she ended up going for lobectomy of the right upper lobe and then lo and behold, she is thus far cancer-free. And when it came back to the community, and we were talking about it in tumor board, the decision -- the question, obviously, the radiologists were like what is different about this compared to every other ground-glass that we have discussed in tumor board that you decided to perform a biopsy of this. And what we found out is the difference is just CyPath. So here, where you have the higher probability of likely malignant on the testing, that is the only thing that gave us the answer for us to pursue biopsy here and lo and behold, we have a patient that essentially at this point thus far is cured of lung cancer. So that is some of the ways in which this has been able to like help justify performing biopsies on patients that are coming in with less than amorphous nodules per se in our practice. And -- but to reflect back on the cases that have already been discussed, Dr. Baptiste would probably have taken that patient based on the pulmonologist saying "Hey, listen, I'm really suspicious about this nodule. I want you to take this nodule out because there's a high risk, but she's also 80 years old." So you're trying to risk-stratify a patient that has got some other comorbidities. This really is helpful in those situations for sure.

Thank you. Before we move on, I just want to remind everybody, you can ask questions in the chat. We'll be happy to answer any questions you have. So far, there have been none. Now I want to take a little bit different approach. We've seen a couple of cases already and heard about cases where CyPath Lung was used to help diagnose early stage, Stage 1A lung cancer is obviously our goal to do so. But it also can be useful as we've talked about, very useful for its negative predictive value and taking cases where we otherwise may have biopsy and being able to use this test with its very high negative predictive value to hold off on biopsy. So if I can have the next slide. This is a case, it's not my case. It's a case of another pulmonologist, next county over from me in New Jersey, Dr. [ Daya Nagaraja ]. This is a patient that he saw, 70-year-old woman, big time smoker, 50 pack years, actually still smoking at the time he saw her. High risk for lung cancer, obviously, based on her smoking also had significant emphysema as we know, another risk factor, actually, independent risk factor that further increases the risk of lung cancer, but at the same time, increases the risk of complications when we attempt to biopsy these patients. So we did the usual initial workup, CT scan, as you see on the top left, with a lung nodule, PET scan that was positive, mildly positive. Risk stratification using currently available techniques. Mayo was 91.3%. Others were anywhere from 50 to 90. So for all intents and purposes, this is a lung cancer. New nodule, PET scan positive, risk stratification predictors, said this was lung cancer. But he also was using his clinical gestalt, something didn't seem right. This patient presented with really new onset, cough and sputum, no fever, no other obvious indicators of infection. But he was concerned, he was concerned about doing the biopsy, high-risk patient with significant emphysema. So he used CyPath Lung, which came back low likelihood of malignancy. As a result, he opted to wait 3 months, repeat the CT scan, and that's the CT scan on the bottom, complete resolution of the nodule. So again, negative predictive value was very strong with this test and it can be used in some cases to reassure patients, even when you know that this is -- I think Dr. Guda's term was junk nodule, patients are very concerned. They've been sent to you because of suspicion of lung cancer. Sometimes it's helpful just to have another piece of data besides you telling them, this is very unlikely to be a lung cancer. But I can do this test, this test, which is, as we know, a very high negative predictive value, and when it is negative, confirming our suspicions, it also helps reassure patients that waiting is okay. All right. In the time that's left because I still see no questions at all, I think we'll move on to the future. Where are we going with this? We know that the numbers of lung nodules are increasing. I mentioned that already, 2 million to 3 million, if not already, certainly in the near future. Risk stratification is key. Biomarkers are going to play an ever-increasing role with noninvasive testing as with CyPath. Dr. Guda, why don't you tell us where you think things are going over the next few years?

The future is a little bit hard to predict, to be honest, Dr. Sussman. But in the world of lung nodules, I think -- like I said, I think people fall into 2 categories, either you are a clinic that is getting a lot of good nodules that are early risk cancers that you want to perform biopsies on them. And you want to rule out the ones that you don't need to perform biopsies on or you're a clinic that sees a lot of nodules that are essentially coming from the community. That are junk nodules or as I have mentioned them or you're like "I'm not sure if I should be performing a biopsy on every single one of these because these could be granulomas and so on and so forth." And I think the future is a little bit more -- in a sense, it comes down to the kind of practice that you have. In our practice, we talk about risk stratification on every single one of the patients, not necessarily just figure out which ones we don't want to perform biopsies on. But for those that are coming in with solid tumor history or those that are coming in with a nodule that doesn't fit every single box, would you consider performing a biopsy on this? So in the future, I think a lot of that is going to come from primary care physicians. They're saying, "Hey, listen, this is the data. I already have a CT scan because that's 1 piece of data. " And then here's a second piece of data that says that you should be performing a biopsy on this. So you've already done a lot of the clinical gestalt and the work on the back end of it before the patient is getting sent to some of our advanced bronchoscopy or interventional pulmonologist or CT-guided biopsy depending on what's available in your resource pool to get tissue. I think that is, from an investigative standpoint, from a procedural standpoint, I think that's probably where it's going to go.

Okay. Thank you. And we have some questions. So the first one is going to go to Dr. Baptiste. I think you can see it in your chat Dr. Baptiste, but I'm going to read it for everyone. In your experience, when performing wedge resections for indeterminate lung nodules, what percentage ultimately proved to be Stage 1 lung cancers on pathology?

I would say just over 50% are Stage 1 because I tend not to -- like most surgeons, we try to go in the OR with a PET scan, with adequate clinical information to stage this patient clinically. I hate nothing more than to find a patient that has a locally advanced disease unexpectedly. And that's a real downer and -- but the vast majority -- I think the majority of people have Stage 1 lung cancer. When I deal with these nodules that are 0.8 to 1.5 centimeters and PET scan negative as far as the mediastinum. I think that this test is going to be very important. I kind of look at it in the sense the way we looked at breast cancer in the '80s and early '90s, when breast cancer became a local disease and they needed neoadjuvant chemotherapy and radiation. And when patients got operated on ultimately had a modified radical or lumpectomy, sometimes there was no tumor to be found. And my hope is that lung cancer is going to kind of go the same way with neoadjuvant therapy in patients with Stage 1 lung cancer, I think that's where we need to go. And I think that's where we're going to be found ultimately. But I think that this test is going to be very helpful when it's negative, and it really prevents us from doing biopsies that aren't necessary. I hate doing lung biopsies that are granulomas or they are fibrous tissue or they're just negative, they are junk nodules, as Dr. Guda says, I like the term, junk nodules. I really, really think that a negative predictive value is going to be very helpful in not having patients go through unwarranted biopsies.

I think that's an excellent point. It's not just that our goal is to pick up these lung cancers early in Stage 1A but also to avoid unnecessary biopsies or in some cases, resections on those that are not malignancy. And again, that's where the negative predictive value comes in. Now we have another question that's very appropriate for our multidisciplinary panel, and I think I'm posing the question to all 3 of you 1 at a time. How has multidisciplinary collaboration changed the way lung nodules are managed? And where are the biggest gaps still occurring? Dr. Guda, we'll open with you.

Actually, this is something that we talk about all the time. We are in the current phase of medicine where every single specialty has something to offer for almost every single disease. I say this as a broad statement, and it's a little bit of a generalized statement, and there's always like some specialists that are like, no, we manage this -- all of this by ourselves, which is true. But when it comes to lung nodules, it's in a very unique position. Because like Dr. Gunuganti was saying, you can have early-stage diseases that will -- that you can actually just give chemoradiation -- sorry, chemoimmunotherapy, and then 25% of them are cured, right? So then the purpose of the thoracic surgeon there is a little bit more diminished in 1 out of 4 patients. At the end of the day, you still need tissue so it comes down to -- the first thing is the story of the patient. What are the risk factors that the patient is coming in. Is that story being disseminated evenly between all the providers, all the specialists and that's why you talk about it in a tumor board and a lung nodule conference, however you want to design it or over e-mail or a multidisciplinary clinic. And then once you have that information, then you decide cumulatively, hey, -- do we want to risk stratify this patient first and then perform a biopsy or tissue? Or do we want to go straight for surgical resection based on all the risk factors that you have thus far because PET scan is as revealing as it can be. Now we also know that PET scans can have occult malignancies in the mediastinum and everything, anywhere between 6% to 21%, depending on your institution and there's good paper to actually talk about that. So mediastinum staging is again important. But the question is talking about how multidisciplinary collaboration has changed the way how we manage pulmonary nodules. It has opened up the conversation and has given importance to those nodules that need intervention sooner rather than just sitting. When I was in fellowship, we had a patient who was a 43-year-old gentleman. He came in with a nodule that was 3 centimeters things got delayed because there was like poor follow-up, poor follow-up. Eventually, unfortunately, by the time he actually got the tissue diagnosis, it was 6.5 months later, and now he was Stage 4. So that is the patient that you want to avoid -- that is a scenario you want to get -- avoid, which is where multidisciplinary comes into play.

Dr. Gunuganti, where do you see the gaps, in these multidisciplinary?

So coming to the multidisciplinary collaborations, we have, in oncology proved at every step of lung cancer journey, from diagnosis, pre-diagnosis to surgery and to do next-gen sequencing genetic studies. And then consistently, we have proved that survival is better with MDT than non-MDT patients. The risk of recurrence is less when compared to non-multidisciplinary collaboration team collaboration. So we have proved many times in many studies that using multidisciplinary collaboration decreased the risk of recurrence compared to a non-multidisciplinary team engagement and improves survival when compared to if we don't do it. So we have proved it all. So definitely in nodule management, multidisciplinary collaboration definitely is going to be a big one because we can't just say, let's do this or that, but we have -- we just opened 5 emergency rooms, incidental nodule project and we have an AI tool. We found 750 nodules in 1 month. We shut down the software because there's too many nodules we couldn't take care of. We can't take care of that many. So we increased the filter from 6-millimeter to 8 millimeters. And that's when we don't have -- not too many navigators to navigate. So it's like -- and then the second thing is, how many health care systems have multidisciplinary collaboration teams in the United States? Not many. If you look at the workforce shortage in South Texas, not just San Antonio, where I'm from, South Texas, there's only 2 thoracic oncology surgeons who only do thoracic oncology work in the community and only 2 in the academics. This is for whole South Texas, right? And then to get a pulmonary consultation for a nodule from primary care physician, it's not easy. So we need to use a test like CyPath to churn out these nodules not -- even we have 5 pulmonaries, we go on round robin to get them all these nodules. We find in the emergency incidental nodule program because we cannot get them to see because most of the pulmonaries, their bread and butter is ICUs, right? They spend less time in the clinic, 1 week of a month, they spend in the clinic, how many nodules can you see, how many COPDs can you see? So -- and I witnessed myself, I went to OR and saw the Ion and EBUS procedure. It's like 15 people were involved for 2 hours. That's a lot of people and then my pulmonary friend is like, why I don't know, I got few more patients in the clinic than doing this procedure. Look at this test, like, this is a noninvasive. So going back to the future, we have a screening test for breast cancer. We have a screening test for colon cancer. We have a screening test for prostate cancer, 4 big cancers. Lung cancer, we barely got the low-dose CT scan. Why were they worried about approving? Well, we find these nodules we keep poking them. Now we don't need to, we do biopsy of them. We can use the CyPath test. It would tell us whether we should do an invasive procedure. That was the most feared thing in this lung cancer screening trials. We're going to put needles on all these nodules. You go just x-ray every 3 months, chest x-ray once a year. Just sputum testing, all these. But now we have a noninvasive test to delineate patients who really need to be taken to EBUS, Ion versus none.

Dr. Baptiste, before I open this question to you, we have several more very good questions. I'm going to limit you to about 30 seconds. Gaps in your case, other than the gap of not having enough pulmonologists in the area, any gaps with multidisciplinary teams that impact you?

No. I mean I have a low threshold for involving my tumor board and some of these discussions with lung nodules. I think the CyPath, the benefit of it is it's less top-heavy. Ion and navigational bronchoscopy, as Dr. Gunuganti mentioned, they are big productions, and they take an hour or 2 hours, they take up OR space. So CyPath is you get none of that. That's -- I mean that's straight from the source. And it's really is going to cover a lot of gaps that we are able to cover. There's just so many of us, physician extenders, pulmonologists, interventionalists, CT surgeons. There's only so many of us. So if you have one more objective data that's collected from a home specimen, I mean, how can you deny that? It's going to be very important.

All right. Dr. Guda, the next 2 questions will combine, they're both going to you. How would CyPath fit into your algorithm when you have an indeterminate slowly growing nodule that falls between low risk and high risk, where would you place CyPath in terms of surveillance, PET scan or the biomarkers? And the next question, very similar. How would you see a noninvasive tool like CyPath fitting into an evolving standard of care for indeterminate nodules?

So I think it's the same question really. It's essentially utilizing the risk stratification platform. They are really good questions. I'm glad this is a thinking mind that's asking this question. A lot of times, we do see a lot of indeterminates, and that's why I said it depends on the kind of practice that you have. If your practice is predominantly being fed by oncologists, they need tissue. If it's predominantly being fed by the community apart from the oncologist then you're getting a lot of junk nodules, right? So these indeterminate nodules is the right place for you to use our risk stratification tool. Irrespective of the tool you use and if the patient is able to bring up enough sputum for CyPath to actually be effective then you are going to be able to get meaningful information to tell you this indeterminate nodule is actually very low risk. I think, you do not need to be worried about doing a CT scan every 3 months. I can push them out to 6 to 12. This indeterminate nodule is likely going to be very likely malignancy. So let me set them up for a biopsy, depending on what access to resources you actually have. When it comes to this when the -- question is about evolving standard of care for indeterminate nodules, the challenge is not just about the nodules per se as an evolving thing. The nodules have always been there. Our understanding of them has changed. And our practice patterns have changed and to make a more complex answer simple. It comes down to what resources that you have that you can actually evolve along with it. If you are in a large institution that is able to spend the money to get your robotics and create a production, 2 hours is a long time for a robotic bronchoscopy, but that's a separate conversation altogether. But you're able to get access to those advanced techniques to be able to perform biopsies, get cryoprobe, whatever it we need to be, then go for it. If you are in a community that doesn't have that access, you're limited by OR time for whatever reason, then you are kind of stuck with risk stratification. You're putting them -- you are putting the patient through a CyPath testing. Initially, if it's like less likely, but they grow on the next CT scan. Repeat the test, repeat the test because you may be seeing something now on the sputum test that you didn't catch before. So if the question is how many times you repeat it, well, you could repeat it with every imaging study that you get if it's low likelihood, but there is still growth on the CT scan. At the end of the day, there is no study that is actually telling you that one risk stratification tool is better than the other, and that can compete with clinical gestalt. If you're suspicious, repeat the test and maybe perform the biopsy.

Thank you. The next question, and in the interest of time, we're going to give short answers. What percentage of nodules do you end up doing CyPath Lung on? And does the specialty, in other words, interventional pulmonology versus surgery versus oncology impact that? Dr. Guda, what percentage of do you do CyPath Lung on?

Currently, we do -- about 30% of our patients get CyPath testing. Like I said, just because our clinic is very much -- we are going to be performing a biopsy and a lot of these nodules coming through. And our diagnostic rate is very high. It's over 90% for the biopsies that we conduct. And in larger nodules over 95%, and we diagnose malignancy at an alarmingly higher rates. It's over 70% of what we biopsy we get that back. Our diagnostic is malignancy. So we perform -- CyPath is about 30% or so in our practice is what we use it for.

Okay. Dr. Gunuganti, what percentage of your patients do you use CyPath on? Obviously, we're talking more about the ones you see.

Yes, definitely. I think most of the time when I see a nodule with the previous history of cancer or 1 or 2 years ago, or any time. Like I see a nodule, patient is in remission or done with the adjuvant treatment and I see a new nodule, I go for CyPath. And then there was a question about what are the benefits of CyPath in patients -- with sort of patients in survivorship, very good question. I see patients 2 years out, 4 years out, 5 years out. Now we have the survivorship. You beat the cancer. We're going to do a scan or we found a 8.2-millimeter or 9-millimeter nodule. I'm going to tell the patient. "Okay, what is this, doc?" And the radiologist says it could be malignancy, it could be inflammation or it could be benign. I love that statement by radiologist, CYA. So I would go answer the patient, "Okay, what is this? Don't worry, we'll do another scan in 6 months." No. I do the CyPath to reassure them because of the negative predictive value. So I'm not very much concerned. It depends on the cuts you do on the CT scan. Let's do this test. You don't need to do a biopsy, I want to watch it. So that decreases the anxiety of the survivor, who has beaten the cancer, and they're now not worried about this newfound 3 nodules in the upper lung or lower lung, 1 nodule in the upper lung, yes.

Dr. Baptiste, since they specifically asked about you, I suspect most of your patients have already been diagnosed and you're not doing a lot of CyPath, but what percentage of your patients?

Yes. So right. So I had 3 cases that were presented to me from Dr. Downie that were CyPath-positive in the past. So my -- I can really only attest to what I'll do in the future. And it's probably about 25% since I do run my own lung nodule clinic. So I would say 25%.

Okay. I'll tackle the last one. How does this impact overall cost of care for patients and practices? There's actually a very good article on this. Unfortunately, I don't have the reference for you, but we can get it. I think this program is going to be put on your website. So we'll find a way to get you that information. But the study looking at cost of care shows that CyPath decreases cost of care, obviously, by avoiding procedures in those patients that have what's been referred to as junk nodules. I think we have 1 minute to go. I will just give Dr. Baptiste, he didn't get to answer the question about the future. You've got 1 minute to tell us what the future is in terms of thoracic surgery. Anything different than now or just earlier diagnosis and earlier treatment? You're muted. You're muted.

I'm sorry. We're seeing data now with early lung cancer surgery that less is better, less resection is better or certainly equal in a lot of regards for 1A and 1B lung cancer. So I'm thinking a lot of similarities with breast cancer and lung cancer. So that's all good. It's all good...

Yes. So I think the genomic. We have been using genomic markers in Stage IV lung cancer. We used to say adenocarcinoma [ squamous ] a few years ago. Now we are not doing that. We divide the lung cancer into 11 buckets. Same thing we drag it to Stage 3 and Stage 2, even Stage 1A. We don't need adjuvant chemo, but we can risk stratify by genetic information who needs adjuvant, who's at high risk of recurrence or low risk of recurrence, not paint a picture, brush with the same brush saying, all Stage 1As are same, let's see if they recur or not. So now we are translating to a nodule level from Stage 4, now the nodule backwards using genetic information than the clinical information.

Okay. And our time is up. So I'd like to thank our panel, first of all, I'd like to thank everybody for attending. And again, thank the Society for Advanced Bronchoscopy. Good night, everybody.

Thank you, everyone, for joining this webinar, and thanks to CyPath as well for sponsoring an excellent, informative discussion we had. This webinar will be posted to the SAB YouTube channel in a few days. So if you would like to review, you may do so then. Thank you.