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Okay. It looks like we have several of our attendees that have joined this evening, so I'm going to go ahead and kick us off. I am honored to introduce Dr. Jose De La Cerda that has joined us this evening. He is from San Antonio, Texas, and he is currently managing urologist at Urology San Antonio and co-director of USA Clinical Trials. Dr. De La Serda completed his urology residency at the University of Texas Health Science Center, and his expertise includes urologic cancers, particularly advanced prostate cancer, and he's authored numerous publications and presentations, so we are excited to have him speak to us tonight about Confirm MDX and how he uses the assay in his practice. During the presentation this evening, all of you are currently on mute, but I would invite you to put any questions that may come up during his presentation into the Q&A that's along the bottom of your screen, most likely. And then toward the end of his presentation, I will be taking all of you off of mute. And at that time, you are welcome to just open up and ask any questions that might come up, and Dr. De La Cerda will be glad to answer any of those for you. So the floor is now yours, Dr. De La Cerda. Perfect. Thank you, Rachel. That was excellent. So thank you, everyone, for being here today and to the team at MDX Health for having me. My name is Jose De La Certa. I'm a urologist at Urology San Antonio. And like Rachel mentioned, I focused a lot of my practice on localized and advanced prostate cancer and head our prostate division of clinical trials. And I know what you guys are thinking tonight is, damn, he's in San Antonio, home of Wemby, the true MVP of the NBA, who just pulled off an exciting win in double overtime last night. So get ready for the championship, baby, because we're coming. And speaking of the MBA, Cavs and Knicks played an hour, so we'll make sure we get you out of here by then, because I know we've had a long day. So with that, we'll get started here. And we're going to be talking about the role of ConfirmMDX in modern post-negative biopsy management. So first thing here, what is ConfirmDX? Well, this is the only tissue biomarker to address biopsy sampling error and identify men at risk of harboring clinically significant prostate cancer. And one of the nice benefits of this is that these patients don't need to come into the office for your repeat urinary test or repeat blood tests. Once you have the tissue, you can just send it off. There's no additional office visit required. In fact, it's the only biomarker in the market that was built on tissue for negative biopsies. And because of its high negative predictive value and the clinical validation that we'll see tonight, ConfirmMDX has been included in the NCCN and AUA guidelines for the early detection of prostate cancer. So what ConfirmDX is doing is truly solving an unmet need in prostate cancer, what we know is this, standard biopsies only measure less than 1% of the prostate, which results in a 30% false negative rate. So one in three men will actually have prostate cancer, even though their biopsy returns as negative. And that's very high and can be stressful to both the patients and even to me. I mean, it's one of the things that keeps me up at night on occasion. So when I discuss biopsies, I'm already discussing this risk of false negative of the patients. And when I get the results back, you know, I am very excited for them. And I say, hey, great, we didn't find prostate cancer. But in here comes a big one, there's always again, that chance that we missed something since we just sampled the prostate. So patients really want the confidence. And I really want the competence that when I say it's a negative biopsy, it's truly a negative biopzy. It also eases the anxiety of having repeat biopsies. I mean, biopsys are invasive. They're not comfortable and they have inherent risks like sepsis and infection. So we can avoid unnecessary repeat biopys by doing confirm MDX. And this helps us provide better medicine and better care for these patients. So we also want to identify clinically significant prostate cancer. I'm not concerned for missing a 5% in one core Gleason 3 plus 3 tumor, but more worried about missing that Gleasing grade group 2 and above where missing one of these potential diagnosis can lead to poor outcomes. So having a test that gives a 96 NPV for a Gleassing grade group two or above is really a game changer. And that's a good, good rule out test. And it saves me from having to take a patient back for multiple biopsies and avoid a transrectal prostatectomy from all the biopsy specimens I've done. So the other thing is it does help reduce the cost of the healthcare system associated with MRI and biopsys. And we really are seeing a shift into value-based care. And rather than getting paid for doing more, we're going to be getting paid für achieving better outcomes. And this is where ConfirmMDX can come in. So, cavernum deox helps improve the detection of clinically significant cancer. And how does it do that? And this diagram shows exactly how the process works. After an initial negative biopsy, the tissue is sent to the lab for assessment of what's called DNA methylation. And again, you don't need to come back to the office. You already have the tissue. Just send it out. Three tumor-suppressed genes are going to be valid for DNA methyation, and that's GST-Pi, APC, and RASF1. Now let's walk down the negative pathway first at the bottom towards the blue minus sign. If these are found to be negative for DNA methylation, that's the 96% NPV coming in hot and giving you that confidence that there's truly a negative biopsy. This patient would therefore go back to routine monitoring where you can continue to check a PSA and DRE every 6 to 12 months. And I think it's really important to note here that when you age adjust and match men that have had a biopsy versus those that haven't, those men that have had biopty are already at a higher risk of having prostate cancer since there was a reason we did the biopzy in the first place, typically that elevated PSA. So it's important to keep an eye on them and make sure they don't get lost in a follow-up. Now let's go up the ladder. If there's positive methylation, this is going to be one of those things that changes the follow-up strategy. Now, we're looking at that top red plus sign. When there's positive methylation, there's going to be a raw methylation score, and we don't see that number. That gets combined with the clinical risk factors, which are age, PSA, PATH, and DRE, and all these are reported at the time of ordering the test. It's actually really super easy. You just place the sticker on the biopsy report, which already includes the age, the PSA in the path. And really the only thing we have to fill out is just the DRE findings there. And then it gets sent off to the lab. So after using that methylation dependent algorithm and combining that raw methylation score, plus the risk factors, we get the individualized risk score. And this is the most important part of the report. It's going to be the score that gives you the probability of finding prostate cancer on a repeat biopsy. So this is good individualized medicine that lets us come up with a plan based on a patient's specific biomarker. Now, this patient would now become somebody that might get a prostate biopzy sooner, closer evaluation, potentially an MRI if not already done so. And we know this about any test. I mean, they can be analytically accurate and they can be clinically valid. But if it doesn't really alter our decisions or outcomes, it's practical values limited. What's the point in using it? Confirm MDX doesn't do that. Confirm MDX is providing the clinical utility of patient management, and it helps us stratify patients that benefit from intensification versus routine monitoring. And that's where it really shines. So we've talked a lot about methylation, but what is it exactly? On top, the blue shows a normal cell with active and functional tumor suppressor genes. So this is a healthy cell and it's functioning normally. These tumor suppresser genes do just that. They suppress the formation of tumors when they work properly after a cell is dividing. Now let's talk about methylation. And methylation is not the breaking bad type of methylation where you're cooking something up and dealing with bodies in terms of sulfuric acid. That's something else. This is DNA methylation, when there's DNA methylation, methyl groups get added to the DNA strand and subsequently cause these tumor suppressor genes to no longer function normally. Now these genes can suppress tumor formation and this becomes a potential for oncogenesis. Now one important thing to know is that methylation is not an on and off switch. Think of it more like a dimmer. The degree of intensity of methylation will vary from gene to gene and patient to patient. So when confirmed MDX is run, it's looking to assess which genes are methylated and the amount of cores and their location. So if a report, for example, only has one gene with methylation, it could be super methylated. And you may see that as a really high percent of risk of prostate cancer on a repeat biopsy. Now, at the same time, you maybe have run another patient and you get the report back and there's multiple areas of methylation but you get a lower number. So it's an important concept as methylation intensity is variable. It's not so much the number, of course, but the intensity of methylation. And just know this, the higher the methylation, the highest the risk, and we're going to see these changes early in the oncogenic process. So methylation is a widely used biomarker assay. We see methylation changes occurring in all other cancers. Take Cologuard, for example, very well known, good advertising, but it's doing that. It is looking at specific colon cancer genes that are methylated and providing that risk of a potential oncogenic process. So these are the three tumor suppression genes in CONFIRM-MDX. And when these three genes are methylated, they're inhibited to a degree, and therefore they no longer fully work to suppress the tumors. And we'll talk about them. We'll nerd out a little bit on these. The first one is GST-Pi. This is the big one. It's found in up to 90% of prostate cancers, and it's a detoxifying agent to prevent genomic damage by carcinogens. Now, GST-PI-CPG island hypermethylation is the most common somatic genome alteration that we've seen in prostate cancer. So GST PI is a big boy. It's very well known and studied. This tends to occur early in the process and is one of the first safety checks that gets turned off in oncogenesis. Now the other two are APC and RASF1. APC controls of speed and the regularity of cell division. And when it's silenced, it's associated with tumor genesis and the production of growth. And then RASF1 is involved in cell cycle progression and apoptosis. And these tend to occur later. So you might be seeing a lot of GST pi, and that's because it does occur early on in that process. So this plays into one of the most common things I get asked, and That is, well, how far from the tumor is it detecting these changes? And the fact is, we don't know, and the epigenetic field effect will help explain why. I love this chart here. When you look at the graph on the left, the dark red circles are cancer, and the light pink circle around cancer is an example of what Comfirm MDX is able to sample. Now this is a perfect circle around Cancer, and we know nothing in oncology is really a perfect circle. So now let's look at this graph on right and pretend you do a biopsy. If you hit the tumor in the middle, that dark blue area, boom, you got it, you're done, found the cancer. Now when we look at tumor cells from prostatectomy specimens or from biopsy specimens, there's often methylation present in the adjacent areas, and that reflects a precursor of the progression of the related field that's called a second field tumor. So on the graph, let's say you do a biopzy and you get to the left side of that tumor in that light blue area. That may be right at the border of a tumor which is eventually going to progress and that's the methylation you're seeing. Now let's say you do a biopsy and you get on that very far right side of the tumor in the other really small light blue area towards the right. Well that might be an independent methylation island of a second primary tumor that's forming. So because of this we can't say how far it measures because it's impossible to know that field effect, where in that process this is occurring. So when I think about this, if I get a negative biopsy and these tumor suppression genes are being methylated now, it may not be because I missed a tumor at the time of my biopzy, but possibly because it has yet to form. This is giving me sort of that warning sign of something to come. So the effects of methylation are going to be seen later, which is why a future biopsychogenic confirmed MDX patient is a strong consideration. And for me, I start thinking about a re-biopsy probably at about a year because that gives it time for the oncogenic process to occur. And I might have a higher chance of identifying a cancer, which might have formed in that time. When I talk to patients about this, I'm in Texas and I have to make it easy for them. So I usually compare guns. I say, okay, when I do a biopsy, I have a caliber 22. That's a straight shot, one bullet we got in there. Now, when I talk about ConfirmMDX, I say now, instead of using a caliber 22, we're actually using a shotgun. I'm able to get more of that area. And they say, oh, okay, I get it now. Then they hop on their horse and get out of my clinic. So having them understand how this works really, really makes a difference into why we're ordering it, and it helps them understand the results as well. So ConfirmDX is super validated. There are multiple pivotal clinical studies and publications on it with over 5,500 patients, and it's been looked at in terms of the analytical validity, health economics, and the clinical utility of this. And it's really all about that negative predictive value. There have been multiple validation studies on it, and just know the higher the negative predictive volume, the better to rule out those patients that don't have clinically significant prostate cancer. and again multiple publications and multiple journals that we're all pretty familiar with here so this is that landmark validation study in 2016 and this is where that 96 NPV comes from this is how the risk score was developed so in this study 803 patients all with negative biopsy were enrolled in the trial and confirmed MDX was sent on all these patients and even if it was positive or negative, all the patients had to undergo a repeat biopsy at about 24 to 30 months regardless of the results. And I know it's really hard to see at the bottom right that area under the curve. And that AUC, the gray line is a PSA, the black line is the PCPT, the blue line is that epi score, that raw methylation score, and then the orange line is risk score. And this is the FB score plus those clinical factors. And looking at the FB and risk score, there's a significant improvement in the area under the curve versus the PCPT and PSA for the prediction of clinically significant prostate cancer in these patients. In fact, it really outperforms that. And we see that here. You can look at these odds ratios. When you look at age, DRE, ATP, or PSA, I mean, confirm MDX is just blowing this out of the water. So with that ARDS ratio of 14. So it's a good rule out test with that high NPV score. But at the same time, it's also a good rule in test. And that's usually hard to do. You usually have to give to get. Here, we're getting both of these. And so it helps us really identify patients at risk and those that are not at risk. So another important aspect is that confirmed MDX is validated in African American men. African American men are often underdiagnosed and undertreated. And many biomarkers that have been developed often come from underrepresented patient populations. And I see this in clinical trials all the time. In fact, the FDA is really pushing for better representation in order for us to really validate these studies in general populations. So this is a study of 211 African American men, and it's using confirmed MDX. And we see here that we get a 94 NPV for clinically significant prostate cancer in African American men. So no statistical change for the Latin mark 96 NPV. We're seeing that this is also validated on them, also helpful and a good clinical tool to use. So these are the reports. They're very easy to read and understand. And we'll go through some of my patients' cases as well. So this is going to be a report for a patient that is DNA methylation negative. At the top of the report, you're going to have their info and the demographics that were sent when you ordered the test. That's what the little sticker is that has all this information. Now the green bar in the middle shows that DNA methyation was negative. So we have a negative biopsy and a negative confirmed MDX result. No need for an additional office visit, just send the tissue directly from the PATH lab. So this gives us good confidence in the results. I mean, with that 96 MPV for clinically significant prostate cancer, 90% MPV für all prostate cancers, and this is for me a patient that's now going to undergo routine monitoring. For me, I'm checking these patients in the office about every 6 to 12 months, repeating PSAs. Not a patient that I'm going to be considering surveillance intensification. Now this patient is a little bit different. This is a positive patient, a DNA methylation positive. And the reporting is going to be totally the same. The demographics are on the top and then the middle bar is going to give you that positive result. Now, this time you have a red bar that states DNA methyation is positive as well as their individualized risk score. So in this particular patient, there's a 12% chance of detecting clinically significant prostate cancer and a 20% chance of a Gleason grade group 1 prostate cancer. Now when you combine these two, the total is a 32% chance of detecting any prostate cancer on a repeat biopsy. So these are additive numbers. Now if you do a standard 12-biopsy template, you're going to get the map down there at the bottom and it shows you the location of the biopsy sample and the genes that were found to be methylated plus where at in the prostate. Now, if you do a fusion or more cores, they won't be mapped out like this, but they're still going to be sent out for methylation and they'll still notify you on the results. So I see the map and the jeans are sort of informative, but I don't really get hung up on them. I really focus on that percent risk of prostate cancer on repeat biopasy, that red bar and the results underneath it. I mean, it really is the most important thing, and this is where the test is shining. Remember, it can be one gene or many genes, but the degree of methylation is what gives that risk of prostate cancer and not the number of genes. So this is a patient that is at an increased risk of having prostate cancer if you were to repeat a biopsy. It would change the management strategy, and rather than put them out on that six to 12-month-year follow-up, you might consider seeing them in the office a little bit sooner, every three to four months with PSAs, considering ordering imaging such as a prostate MRI if you haven't already done so, just to rule out the possibility of a tumor or missed tumor, and rediscussing a repeat biopsy sooner if they continue to have elevated PSAs or other risk factors. So again, ConfirmMDx has clinical utility that can help us get better treatment and outcomes for patients. It's included in the NCCN AUA guidelines with that strong 96% negative produce value, and the ability to identify men at risk for clinically significant prostate cancer. And one thing to really know is if you're considering using ConfirmMDX, you can send it out for testing up to 30 months from when the biopsy was performed. So if you are seeing a patient in the office now, and let's say they have a rising PSA, and you've had a biopzy in the past within 30 months, and you're considered pulling the trigger on a repeat biopsy, pun intended, then consider sending out ConfirmMDX first because that might actually help you sway one way or another, sort of continuing that surveillance or potentially moving forward with that repeat biopsies. So that would be a really good patient to start on if you don't have much experience with ConfirmDX. All right, so here are my cases, and these are all actual cases from my practice. There's going to be two patients that we discussed that are going to have a positive confirmed MDX. And then there's going to be two patients that we discussed that are going to have an negative confirmed MDx result. So the first case is a 64-year-old Hispanic male with a history of an elevated PSA confirmed to be a 7.58. And his DRE was negative at the time of the office visit. He does have a Positive Family History of Prostate Cancer in his father. And one of the things I do is in all my patients, when I'm considering doing a prostate biopsy is trying to order an MRI of the prostate on all of them. But for a lot of reasons, you know, anxiety, coverage, out-of-pocket costs, all those things, not all of us can potentially get it. So in this particular case, it wasn't covered by the insurance. So we didn't do an MRI and proceeded directly with the biopzy. So, we do a biopcy and it comes back benign in 12 course. And we run confirm MDX and these are the results I get on him. So the likelihood of detecting Gleason score seven or above on repeat biopsy is 25%. So one in four, pretty high. And then the likelihood of detecting a Gleison grade group one is also pretty high at, sorry, 25% and 24% here. So when you add these up, it's 49%. So about a 50% chance that if I were to repeat a biopzy, it is going to be pretty high. So how does this change things? Now we have positive confirmed MDX, sort of what's next? What do I counsel the patients on? And I always counsel them and I say what it means. It doesn't mean that you might have cancer at this moment in time. It means that you're at risk of developing one or potentially the chance that we missed one. But at least we know now that we can do things to minimize the risk of having a missed cancer and so the first thing I do is I re-risk stratify and now I'm shifting more towards biopsy favored versus surveillance favored so again I'm looking at the PSA trends and the density and what we all normally do you know look at the DRE if there's a nodule there that could increase the positive predictive value of finding something the family history I look at previous biopzy details like the cores and where it was sampled from. In my practice, we all have a surgery center here and we all rotate for prostate biopsies. So in one day, it might be me doing 25 prostate biopsy, but I'm doing it for the entire practice. And so we stack them up. And So everybody might do them differently. And so I might want to see which of my partners may have missed some samples there, or maybe not sampled the right areas. But really, I kind of look at any biopasy the same way, I want to make sure that I know what was sampled and where we could have potentially missed something. And the question I ask is, are the risk factors high enough to repeat a biopsy sooner rather than later? Is this a patient that I can sit on for a little bit safely or somebody that has a really high percent of having prostate cancer that I should probably biopzy sooner? The first thing, if I haven't done so for whatever reason, is I try to get that prostate MRI covered because if they've had a negative biopasy, typically a little easier to get that prostate MRI covered afterwards. So we know that MRI has been really great to help us make decisions. But alone without taking other tests into context, it may miss clinically significant prostate cancers. In fact, up to about 30% of men with negative MRIs can actually have a clinically significant prostate cancer. But when there's a PI-RADS 4 or 5 lesion on an MRI, I mean, that positive predictive value goes up pretty high. It's up to 70%. So MRIs give us the good anatomic detail. It allows us for a fusion biopsy. And for me, when I think about it, MRIs looking at the geography and then confirmed MDX is looking atthe biology. And both of these actually, when they work together, you get the best benefit. It shouldn't be one or the other. You know, I think that we can easily integrate these and then use this to give us the best clinical utility and decision on whether or not to repeat a biopsy. So if I haven't done our over prostate MRI, and if it has a MRI of pirates three or above, I'll go towards that fusion biopzy next. Now, if the MRI is negative, remember, we're still not safe. 30% of MRIs can miss that prostate cancer. So now I stratify these are these high risk patients or lower risk patients. If they're high-risk patients, like that greater than that high probability, for me, it's about 20% of clinically significant cancer. That's what I use. If They're younger and there's a strong family history or they're African-American, then I consider a biopsy a bit sooner versus monitoring closely. Now, if it's a low-risk patient, you know, they don't have that high probability of a clinically significant prostate cancer. Maybe it's just a little bit higher on that Gleason grade group one. Then I'll just consider a shorter interval follow-up, and then I might consider adding other biomarkers or even repeating an MRI in 12 months and see if there's been any evolution in their MRI. And then the threshold of biopsy will increase as the PSA rises, of course, as the MRI drops, or for whatever reason, if there's clinical suspicion that indicates these patients should get a biopzy sooner. So in this particular patient, remember negative biopsy, positive confirmed MDX, no MRI. I will, he turned 65 and finally he was on Medicare and I was able to get an MRI. So I order an MRI and it shows a PI-RADS 4 in that right peripheral zone at that mid gland. So these findings, we decide, okay, let's take you back to do a MRI fusion biopzy now that we've had this. And we get a fusion biopsying and we identify that he has Gleason-grade group 1 prostate cancer. So his biopsy results on the left and his confirmed MDX results are on the bottom right. And I really like real-world examples of things that happen because sometimes you don't expect them. This is a really great example to rediscuss the concept of methylation. This has DNA methylation all over the place, on the right side, on the left side, but remember, it's not necessarily a map. Methylation is an oncogenic process and it can be a predictor of future tumors. So here his diagnosis wasn't from the standard biopsy. It was from the fusion biopsies that we did. And that's where we identified that Gleason 3 plus 3. So again, look at it as a whole, not so much as where am I going to find prostate cancer, but what is the overall risk of this patient having prostate cancer? So here's a second case. 65-year-old white male with a history of elevated PSA comes into the office and our PSA, it's a 7.9 and it was last checked 18 months ago by his PCP, and it was a 5.1. So I do a DRE. It's normal. He does have a large prostate, and he's already on Tamsulosin. Negative family history. So we say, okay, well, let's get an MRI and see what it shows. And here we have a PI-RADS2 MRI with the volume of 73 grams. And again, a negative MRI doesn't rule out prostate cancer. So, we discuss, you know, biopsy monitoring. So let's do a biopzy. Let's make sure everything's okay. And we get a biopsied and it comes back as benign in 11 cores and then one core with high grade pin. So as a side note here, if a patient has high grade pen atypia, you can send confirm MDX on it. You're still going to get that run for methylation. So we send it off for confirm MDx and we get the results. This is an older report, so it's a different color. The first case is the most modern one. This was just a little bit older from 2024. Now in here, the likelihood of any prostate cancer on repeat biopsy is 38%. And the likelihood Of a clinically significant one that Gleason score seven or above is about a 17%. 21% of Gleison score six or below. So I talked to the patient, I'm sitting back in the office, we go through it. And he says, let's just monitor. So it's okay, well, let's just keep a close eye on you. I'll be repeating your PSAs. So at the time of biopsy, his PSA was a 7.9. And I see him three months later and it's up to a 9.0. But around this time, he starts having worse and knowing Lutz and he wants medications. I talk about, you know, cystoscopies and procedures. He doesn't want that, just wants meds. So we start him off in an asteroid. And then I say, well, let's see what your PSA does in six months. It should have by then. And so let me push you off a little bit, recheck you in six weeks. So six months later, his PSA just goes down to a 7.04 and it did not have as I expected. So now we have this sort of rising PSA because technically we're at a 14 positive confirmed MDX. And we say, okay, it's been about a year. Let's redo a biopsy and he's amenable at this point. So we do a biopsying and then upon repeating his biopzy, we find that he actually has a Gleason grade group two prostate cancer so we find three plus four and two out of the 12 cores um and so i see him back in the office we discuss and i send this test out for gps and there's a little shout out mdx team so her gps uh higher risk for adverse pathology and we decided to do a prostatectomy so this is one of those cases where the confirm md x really helped me change the outcome of this patient and what was going to happen next. And he ended up having actually four plus three in one of the cores. So it was actually a good call. So case three, and we're going to start jumping into the negative biopsies. Sorry, the negative confirmed MDX results. So this is a 63-year-old black male with an elevated PSA. His PSA is a 5.4. DRE is benign. No family history. He's claustrophobic, doesn't want to do an MRI. So we jump right into a biopsy and we get benign in 12. So I send this off for confirmed MDX and we can get that nice green letterhead that says DNA methylation negative. So it's that, all right, good. That sigh of relief that, hey, you're truly negative. You have that 96 NPV. So now you get that negative confirmed MDx, what happens next? How do you manage these patients? First thing I do, like we do before is you always re-risk stratify. You're now shifting towards a surveillance favored sort of stratification. And you're essentially ruling out any clinically significant cancer because of that high NPV. So I start seeing them in the office every six to 12 months, yearly DRE, and I monitor those PSA kinetics, make sure they're not rising, that velocity is staying stable, no increase in their doubling time. And I consider an MRI if their PSA starts rising or if or DRE changes, even if I already have a negative one to begin with. And then a trigger for a re-biopsy, I would overwrite that negative MDX test as if the PSA consistently rises, I get worsening other biomarkers of PI-RADS 3 plus on the MRI, or if they're just high-risk clinical features and your suspicion is, let me just ensure that I'm not missing anything and let me do a repeat biopsy. So he decides, and well, we both decided, let's just monitor your PSA levels. And we do just that. So in April of last year's PSAs of 5.4, it goes up in six months to about a 6.1. I'm not really worried about that. And then it goes back down this past March to a 5.8. So he's been doing well. We've just been keeping an eye on his PSAs. But if anything were to change, first thing I would do is to order an MRI and then assess sort of those PSA kinetics. So the last patient here, this is a 61-year-old Hispanic male with an elevated PSA. July of 2014, his PSA was a 4.7, had a negative DRE at the time of his visit, but did notice he had a large prostate. Now, he does have a positive family history of prostate cancer in his older brother and his uncle. Both of them have a required intervention. So he's really anxious because he's seen what they've gone through. him. I talk about an MRI, but he says, Hey, I just want to do a biopsy. Let's just make sure everything's okay. That's what my family had. And I said, okay, let's do a biography. And luckily biopsychiatry comes back as negative. And they send the confirm MDX and we say, okay. You got negative results here. We get that sort of, again, the reassurance that we're not missing a prostate cancer here, but anything is like anything in life is not reassured. That for sure. So we decided to monitor and in october 24 his psa is at 5.5 then in march of last year it goes up to a 6.9 and then six months later it goes upp again 7.4 so we're having these consistent rises so he has a rising psa the strong family history we don't have a prostate mri so that's the first thing i do let me order an mri and see what's going on so i order an MRI and again 72 gram prostate and PI-RADS 2. No prostate cancer per PI-RADS criteria on this MRI. So we say, okay, we have a negative MRI and a negative confirmed. Let's just keep an eye on you and sort of see what happens after this. So despite this, his PSA continues to rise. And this is a super anxious patient. He's really worried about it. And, you know, he does have a strong family history, the rising PSA, we said, let's do a repeat biopsy. And we do a repeat biopsied and it comes back also negative. So I get that second negative biopsey. So we got the negative MRI, two negative biopsies now, and then most importantly, that negative confirmed MDX. And again, the most important thing to note is that all these men are inherently at higher risk for having prostate cancer versus the average age adjusted male, just because that's something that required a biopasy in the first place. So ensuring good follow-up is key because cancer can develop later in the future. In the meantime, it's really nice to know that we have a test that can help us guide and make these decisions and provide better care for our patients and at least give them and ourselves some reassurance about the next steps. So with that, we'll go into some questions. Thank you for being here tonight. Thank you so much, Dr. De La Cerda. We do have a question in the chat. In the one case confirmed was used with high-grade PIN on initial biopsy can confirm also be used if ASAP is on the initial biopsies. So, De La Certa, do you want to answer that? Yeah, it certainly can. You can send it with ASAP, atypia, with PIN, and you get the same methylation process there too. In fact, I think those are really great reasons to send it when you have these sort of precursors of a potential tumor and cancer, and then you have that sort of second stop where you're ordering that confirmed MDX to also give you that potential for a positive. Yes, perfect. Okay. I am not quickly enough going down and allowing everyone to talk. So if you are not already being allowed to talk, I am quickly going through and unmuting everyone. But in the meantime, I do have a couple more questions for you, Dr. De La Cerda. So when a patient, I know you mentioned earlier in the presentation, you know, you talk to the patient and say, okay, your biopsy was negative, but we do run ConfirmMDX and you've got a positive ConfirmDX report. So how do you personally talk through that positive result with the patient? And then if you can add the layer onto that, if that patient had an MRI and maybe the MRI result, you know, was part three, let's say, how do You have that conversation with them? Yeah, and it's always goes back to the whole point, I always get a little diagram right in front when I talk to them, I have prostate models all over the place. And so I said, let me show you how a prostate biopsy actually works and use my pen to demonstrate. We're just, you know, checking areas of the prostate. So from this area to this area, there might be a potential gap that we miss. And it's impossible to take 200 biopsychiatry samples at the same time. So whenever we're running your tissue, from what I sampled, we didn't find prostate cancer there. But at the time, it could be that it's something so small or so early that we're starting to see the changes genetically, but it's not there yet. And so I see that as like, Hey, think about this. Like as a little forest fire, it might be a small simmer. We don't want this to become a forest fire. We want to find this early, put it out early. And that's how we're going to keep an eye on you. At the same time, I tell them the same thing with an MRI. I get a lot of guys that come in and they say, I just want to do an MRI and if it's negative, I don't Want to do anything. And I say, well, the MRI is there to give us more information because it can help me target a potential area that we see. But even an MRI might not show you if you have prostate cancer, you know, most of these men can have missed cancers on MRI. And so it's always that sort of baseline education, knowing that these tests are helpful, and they should be all taken as a whole, including their risk factors. Thank you for that. So in case three, you elected to monitor with a negative result, even though the patient was an African-American man and had an elevated PSA. I know you mentioned specifically that that was a joint decision between you and the patient, but can you speak to how race typically factors into your monitoring thresholds? And do you apply confirm MDX results differently, potentially in, say, African-American or even Hispanic patients? Right. We know we know in general that African- American men are often there's a lot of health inequities and they're often underscreened and underdiagnosed. diagnosed. So when I get the results, I know that this has been validated in both Caucasian men, Hispanic men, Black men. And when I see that, I look at the results the same, you know, it's all about that individualized risk score, because it's applying some important things that we know, your age, your PSA, your DRE, all known risk factors for potential prostate cancer. And of course, when I seen the African American male, I think, okay, this patient is already at a higher risk for prostate cancer. But race alone isn't going to be enough to sort of sway my need to do a biopsy sooner. It's, again, looking at that individualized risk where that would really do it. Great. And then the last question we've got here is for a urologist or district provider in general who may have never ordered ConfirmMDX before, is there a particular patient type or scenario that you'd recommend trying it on first? Yeah, I think it's that patient that you might be seeing them this week or tomorrow in the office where they're in that bucket where you've had a biopsy done within the past couple of years, their PSA has still been high and rising. Maybe you see that that PSA velocity to kind of get Nancy Yeager's question in here is going up. I mean, I think that's a perfect patient because you already have the tissue. You just have to send it out. And so if it's a Medicare patient, you don't even need to worry about any out-of-pocket costs. It's covered by Medicare. So that's the perfect patient I think you can start on to get the results, see the reporting of it, and they might help kind of sway you one way or another. And for me, in terms of the PSA velocity. I mean, the PSC velocity alone NC isn't, you know, I think it's important. It's beneficial. I certainly look at the kinetics of it. And I know, over time, as we age, and as our prostate girls, we're going to have a rising PSA philosophy. So I look at sort of the rate, but the velocity is influenced by a lot of things. It can be from prostatitis, from having sex from UTIs. I means, a lot different things can look at that, but nothing is going to influence the tissue that you send off. That's the patient's inherent genetics. Do I order it on all my biopsies? I do, yes. I order in on all of my negative biopsys. And right now we're in the middle, our practice is working to sort of streamline that. So when we have a negative biopsis, it can be a potential reflex sort of order. And for anyone, not everyone can see the chat, but a question that was put in the chat is, does Dr. Taylor-Seredak order ConfirmMDX on all of his negative biopsies? So you do have the option with ConfirmDX to order it on any patients that you want to. So we accept anything that's not a diagnosis of cancer. So ATAP, excuse me, atypia, ASAP, high-grade pen, benign, and so that was a pitch. Any other questions for Dr. De La Serda? All right. Well, I appreciate y'all being out here tonight after a long day and go Spurs go. Rachel, thanks again for having me and thanks for everything. Okay. Yes. Thank you. I hope you have a great evening. Thanks. You too.