Healthcare Policy and Diagnostic Advancements: Insights from Dr. Bruce Quinn

• Special guest: Dr. Bruce Quinn, an expert in diagnostics and healthcare policy.
• Topics: Diagnostic advancements, AI in healthcare, precision medicine, and healthcare policy.

Episode Highlights:

West Coast Update:

• Dr. Quinn shares a weather update and personal reflections from the West Coast.

AI and Precision Medicine:

• Discussion on the embryonic stage of AI and precision medicine integration.
• Specific applications of AI in diagnostics, including grading cancer and recording patient visits.
• Dr. Quinn’s personal experience using AI tools like ChatGPT for medical inquiries.

Investment Trends in Diagnostics:

• Surge in diagnostic investments driven by AI and precision medicine.
• Example: Sophia Genetics’ recent performance.
• Impact of COVID-19 on biotech investments, with companies like Invitae experiencing dramatic valuation changes.
• Challenges in the fundraising environment for new diagnostic ventures post-COVID bubble.

Consumer Diagnostics:

• Exploration of retail diagnostics and at-home testing.
• Challenges in advancing point-of-care testing and its unmet needs.
• Potential for integration with consumer health platforms like Hims & Hers and Roman.

Genomics and Financial Landscape:

• Overview of recent acquisitions, like LabCorp acquiring Invitae.
• The fluctuating valuations and investor confidence in the genomics sector.

CMS and Healthcare Policy:

• Dr. Quinn discusses the CMS Moldex program focused on genomics and its impact on diagnostics.
• Innovations in Medicare to support chronic disease management and dementia care.
• Regulatory changes and the future of lab-developed tests (LDTs).

Prostate Cancer Diagnostics:

• Advances in diagnostic tests for prostate cancer and their clinical implications.
• Importance of precision diagnostics in treatment decisions.

Neuro-Diagnostics and Alzheimer's:

• Emerging blood tests for Alzheimer's disease and their integration into clinical practice.
• Genetic testing and its role in diagnosing and managing Alzheimer’s disease.

Regulatory Landscape and Elections:

• Impact of upcoming elections on healthcare policy and CMS innovation.
• FDA’s proposed regulations on lab-developed tests and potential industry shifts.

Closing Thoughts:

• Predictions on future investment opportunities in diagnostics.
• Areas of growth: precision diagnostics, AI applications, and molecular pathways in diagnostics.

Creators & Guests

Host

Rick Gannotta

Health sector executive clinician educator & researcher, RTs/links 🚫 not endorsements, TEDX; https://t.co/51mnBxpPqv @NYUWagner

What is Healthcare Nation?

Welcome to Healthcare Nation, the podcast for enthusiasts passionate about the healthcare sector and eager to explore its current state and future trajectory. Join us as we delve into the heart of the healthcare, biotech, and MedTech industries with the help of top thought leaders.

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Rick Gannotta: [00:00:00] [00:01:00] Again, welcome to the Healthcare Nation Podcast, our guest, Dr. Bruce Quinn. Bruce, so good to see your face, my friend.

Bruice Quinn: It's nice to be here having, thanks for having me back again.

Rick Gannotta: How are things out on the West Coast? I.

Bruice Quinn: We're doing great. Spring is here. It's 75 degrees beautiful weather. So it's, it's nice. Very good.

Rick Gannotta: I am envious. I'll have to pay you a visit in the near future. That's definitely on, on my list, Joe, we'll have to do a, we'll do a pod remote podcast [00:02:00] from la Listen, Bruce, we got a lot to talk about. You know, your field of expertise, which I always think about in the diagnostic realm. What's happening in that space reimbursement, the policy implications, CMS.

Everything coming together. I just see what's, in fact, I think really emerging in the investment side, which is a lot of the diagnostic, you know, side really catching fire now with, with what's happening. But what piques my interest is, is it mostly, and I'd love your candid assessment, is being driven by AI and precision medicine.

What's, what, what's your thoughts on that?

Bruice Quinn: Well, I think if you ask what's the impact of precision medicine and AI today and, and their intersection, it would still be pretty embryonic. But I think a lot's going to happen. I mean, there are companies that are publicly held, like Sophia Genetics that are moving very fast. They just had a quarterly announcement that, you know, 10 or 20%.

And I think there are some specific areas when you look at the lab industry. I think the ability to do things like [00:03:00] grade breast cancer assess her two new staining grade prostate cancer. It can be done much more accurately or will be done much more accurately with, with artificial intelligence than with human beings with consistency and precision and so on.

Counting mitosis, you know, for the aggressive aggressiveness of a tumor, that's something that a machine can surely will be able to do better than a human being. So those are some very specific applications. More broadly, you know, you have things like generating automatic electronic health records recording a patient visit.

I think that's gonna be very doable within a couple years. I mean, people are obviously working at that already, and then there's just understanding things and dealing with this enormous breadth of what medical knowledge is. I had her run in with some, somewhat obscure health problems and sort of odd laboratory tests, and I found it extremely helpful to use chat GTP [00:04:00] and say, you know, you've got these six things going on at once, what are some of the explanations?

And I have no problem not taking it. Absolutely. Literally, you know, taking it as some signposts, some guidance, some additional information, and then filtering it myself. To me that's easy to do and natural to do. But yeah, even in my own case, I found that very helpful.

Rick Gannotta: You know, when I think about applications, certainly in this space, in, in one of your areas, I think of interest, which is precision medicine, the, the. Large language models. The ai, I almost thought of it as as a, as attacking the low hanging fruit first, maybe pre-authorization, maybe moving into step therapy, looking at accelerating the velocity of care.

Along those lines, what are your thoughts on that? I.

Bruice Quinn: Well, I, I, you know, I think sometimes it's, it's over promised a little. I think there are some things that really all you need is a simple 10 word algorithm or a 10 word rule, and you don't actually need. Artificial intelligence to make that decision. You know, did [00:05:00] you have test A before? Test B doesn't require ai but there's a lot of interest in using it for pre-authorization, for, you know, writing concise and accurate summaries of a three or four page medical note and giving the paragraph of pre-auth that the person actually needs understanding patterns and denials, which are a big problem or a big issue in the lab industry.

Definitely there's room for that. I mean, I find. AI is incredibly good at summarizing things. When the FDA lab developed test rule came out last fall, I wrote a 15 or 20 page white paper about it, and then when I was done, I wrote a one page executive summary. My one page executive summary just didn't read that well.

I wasn't quite happy with it, so I dumped the whole 15 page white paper that I had just written into chat GPT and asked it for a one page summary, and it produced a better one page summary than I could write. Just yesterday friends of Cancer [00:06:00] Research put out a paper about circulating DNA detection in cancer, and it comes with a press release and a website, and I dumped those all into chat GPT and asked for an article as if you're a journalist.

And it came back with a perfect four paragraph article that was as good or equivalent or similar to what I could have written by hand in 20 minutes. So there, there are some really amazing things that are already right in front of us and, and that you can do right now.

Rick Gannotta: Yeah, and I think in particular in the space that I know you're probably most familiar with when you think about diagnostics and what's happening in that whole discovery world, including genetics and genomics. But let me shift a little bit and I. Talk quickly about, you know, how that's translating over into the financial kind of area that's that part of the health sector, particularly with impact funding, major acquisitions.

I know most recently [00:07:00] LabCorp acquired, is it Invita?

Bruice Quinn: Yeah, the San Francisco

Rick Gannotta: Vita.

Bruice Quinn: Company.

Rick Gannotta: So that was that piqued my interest. Why don't you give us a little background on that, but, but also kind of weave it through what the broader kind of landscape looks like in terms of those acquisitions and maybe the rational behind it with respect to the positive side of the field going in that genetic space.

Bruice Quinn: Well, the genetic space has been an interesting one the last five or six years, and I would say starting a couple years before Covid invita was. One of, you know, you had myriad genetics classically in that space for 20 years. Then Invitae came along eight or 10 years ago with an i, a big IPO and subsequent rounds of investment during the Covid bubble in biotech around 2021, you had semaphore later renamed Gene Dx, come out with hundreds of millions of dollars of fundraising.[00:08:00]

And if you look at. As an index or as a harbinger. The share price of invita before Covid was around $15. Then around 2021 it went up to 50 or 60, and then it crashed to a couple dollars and then bankruptcy all in the period of a couple years and without any changes in their business fundamentals there.

Sales rode 20%, rose, 20% every year. Their net income rose or, well, they were losing money, but their, their. Gross margin, you know, was basically the same. So all of these statistics were basically the same or gradually improving while their share price, meaning the investor view went from 15 to 60 to zero in in 24, 36 months.

So I think there's a lot of uncertainty in how to value things. Would, would not be a very, an overly insightful conclusion. Semaphore was worth many hundreds of millions of dollars crashed by I think 80 or 90%. So there's, there's a lot of [00:09:00] difficulty in valuing things and I think that's creating something of a hangover in the, the market now.

I hear. Clients and other companies I talked to talking about the fundraising environment being a lot harder now than it was 24 months ago where there was a covid bubble that had not only to do with diagnostics or vaccines, but it just spread over the whole biotech industry. Artificial intelligence and genomics included.

Rick Gannotta: But you think the Covid bubble, as you describe it, that really did inflate. You know, bubble, like a lot of those valuations,

Bruice Quinn: Absolutely, and it, it was equally strong or quite strong in companies that had nothing to do with covid testing. It wasn't just the extra billion or $2 billion in covid testing. It was companies that do hereditary genetics that had nothing. No, no contact with covid.

Rick Gannotta: Right now, Bruce, let me, let me stay on that. Now, when you think about investment trends, particularly in genomics, genetic space, and thinking about this post covid world some of what you just [00:10:00] described with perhaps these inflations and valuations that were, you know, I. Directly related to that, what do you think are the, I guess remaining sides of what, what, what are we looking like on the other side of that whole post covid world, and how is that impacting innovation?

Are you seeing it happening at the same clip or are. These big ideas only the best are getting funded. That's been my premise for a while. It used to be, you know, a couple years ago everyone was getting money. Now it's gotten so much more narrow. I think with respect to the hurdles, folks have to, really achieve before they get the kind of funding that was maybe easily found Covid, your thoughts.

Bruice Quinn: Well, I think if we could really define what's best effectively, it would be easier to move forward. But I think there's a lot of uncertainty defining what's best, especially if you're an early investor. People have pilot ideas, they've got. [00:11:00] Some idea what an addressable market is. They've got pilot data on how their test will perform.

But until you're a few years downstream and actually know how the test performs in large populations you, you don't know how good it's gonna be. And of course, the same thing happens in drugs. You know, a lot of new 90% of drugs fail between phase one, phase two, phase three. But people understand that in the biotech industry, and they, they know that there's an 80 or 90% chance of something going wrong, you know, over several years of drug development.

But the same logic is really in diagnostics too, because you don't usually don't know early on how well the test will perform.

Rick Gannotta: Right. How about what, what are the trends looking like now in the retail space of diagnostics and, and at home?

Bruice Quinn: Oh, that would be a great area. I mean, people have been trying to do more at home diagnostics, more point of care or, or point of care diagnostics for years. It's, it's not something people came up with two or three years [00:12:00] ago with companies like Q and others. It goes back 20, 30 years. I. I recall there was an expert on point of care diagnostics as Mass General, who was very prolific 20, 30 years ago, talking about the promise.

And it's always been a promise like home testing that's been largely out of reach. I have not really seen it moving faster in the last year or two that in a tangible way that in terms of accomplishments that, that I see, I know there's, there's great deal of interest. There's all the NIH investments that went into diagnostics of different kinds.

But I think you also have to address exactly what is the unmet need. Does someone with stage three kidney disease need a home kidney disease test every week

Rick Gannotta: You know, Bruce, the consumer side of things interest me, has interested me for a while. I look at companies like hys and Hers and Roman, and what they're doing online. And so much, I think that [00:13:00] his, it's not telemedicine, you know, it's more because it's, it's asynchronous, but I'm waiting for there to be a diagnostic component of that that really catches on where it's not necessarily point of care at home.

I wanna test, I do it on my own, but really it's tied to something or some platform that's out there that I subscribe to. Are you seeing any movement on, in, in that

Bruice Quinn: It's interesting you mentioned him and hers. I think some of those companies like that and with drug prescriptions are really moving into a, a space that had been left vacant. So it's a, it's a natural market for them to move into. But again, I would say how often do people need, how many tests? You know, and do people, do people need a weekly CBC or a weekly thyroid hormone or a weekly?

Kidney test. I think that's, you have to, you have to have a fundamental unmet need that would really be improved by that [00:14:00] point of care test and not just the, the theory of point of care testing or the concept of point of care testing.

Rick Gannotta: Right. Let me depart from, let's say, the simple stuff and go to to the more complex. When you look at the interventional side, say CRISPR technology, what's your thoughts in that space? Gene editing and some of the advancements that we've seen and the implications for that moving forward.

Bruice Quinn: Well, I don't pitch myself as an expert in, in, in CRISPR biotechnology in terms of, you know, personalized medicine therapy development, but it's, it. It's for some of these, we actually, we can circle back to diagnostic tests. I think we, they're, they're, they're entering areas where we really need better diagnostic tests.

The antibody drug conjugates, which are very fast moving area. There is an excellent review in nature drug discovery a couple weeks ago. It's not just Herceptin plus a tag anymore, right? There are a lot of drugs coming out that are drug conjugates and many [00:15:00] more in the pipeline, and there's very little in the way of diagnostic tests that will help.

Address those and I've, I've talked to some startups in that space. I think that that area is in inviting better use of diagnostics for sure.

Rick Gannotta: Yeah, I can't help but think when you know you have access. Where our conversation started with chat GPT and Advanced Language Models, and I. That level, level of, of feedback that I think is better than directional, that at some point that is going to be married up with, you know I feel this way.

What does this mean diagnostically? What do I need to test for? And at that point, I have a platform and it's the internet of my medical things all, you know, at my disposal, at my keyboard, you know, how far away are we from that? Bruce, when you think about the regulatory aspects, the resource [00:16:00] components and what we're thinking about even from you know, interpretation of, of some of these sophisticated diagnostics.

Bruice Quinn: I would call it the longitudinal view of the individual, and I think we're, we're, we're probably ready to, to do demonstration implementations of that today. So just like you can have a, a chat GPT that's honed down to your company and your company's records. That's private. You could have a chat, GTP or the equivalent that's honed down to your medical rest records and your history and what you've had and be able to, you know, project forward from that.

Certainly it would do, I think, as well as a human doctor reading 10 years of, of records, but it would, the human doctor would take an hour and the, the AI would take 10 or 20 seconds.

Rick Gannotta: Right. Incredible. When you think about it, of course there's been buzz out there that maybe some of these very big let's just say Amazon-like companies [00:17:00] might create an avatar based on this passive acquisition of all kinds of data. But what you, I. You know, watch what you buy at the grocery store, what you consume online, and even through their clinical platform, you know, some of your diagnostics, and create this, this digital twin of you, you could see could have tremendous utility.

Bruice Quinn: Yeah, there's the medical digital twin. There's the marketing Amazon digital twin. I mean, I think they're trying to do digital twins today, although the stuff I see is, is not that interesting. You know, it's like we do a search for swimming pool chlorine, and then we get ads for swimming pool, chlorine. It, it, it, I am not sure that it's that different than it was five years ago.

Rick Gannotta: Right, right. Let me switch gears here to a subject that I think is fairly near and dear to your heart, and that is CMS. And a little bit on the, on the healthcare policy side, what's happening in the CMS space when we look forward, [00:18:00] we'll stick to diagnostics, gap fill, pricing, those issues that are, that are coming up.

What do you see? Bruce, when you look at the tea leaves.

Bruice Quinn: Well, thanks. Yeah. I, I, I, my. My bullet line is that I'm an expert on how Medicare handles new technology. I think in the field of diagnostics, some 10 years ago, they set up a special program that involves about 30 states that they call Moldex, M-O-L-D-X. And it has its own four or five medical directors.

It's got its own policies, it's got its own billing and coding rules, some of which are quite complex, but they have really strive to. Keep innovation moving forward and even to bend, bend the rules or find leeway in the rules where they could. This Moldex program recently put out an article about pathologists ordering genomic tests.

And if you're a, a Medicare nerd there's a regulation that [00:19:00] says only a treating physician can order diagnostic tests. A physician who is treating the patient for a particular medical problem and so on. Uses the test in his care. And my reading of that 30 years ago when it was written was it was meant to exclude radiologists and pathologists from ordering diagnostic tests.

That was what the author was trying to do, but he didn't do it by saying Pathologists can't order tests. He did it by saying, you have to have all these criteria to order a diagnostic test. And Moldex went back and read those rules with an eye to letting pathologists order some genomic tests and concluded they could.

So it's almost like when the Supreme Court goes back and reads some century old law and it reads something new in it. It takes it in a new direction. MALDI has taken this 30 or 40-year-old regulation. Which I would call against pathologist ordering diagnostic diagnostic tests and flipped it around 180 degrees and, and published an article on that.

Well, that would have enormous value for things like lung cancer where you really want to have [00:20:00] genomics early. You're not dependent on which surgeon or did the biopsy or which oncologist in two or three weeks is gonna take on the patient. You really want them to come with the diagnosis of the cancer, whether the lymph nodes are positive and what genes is it's expressing. That's, that's where MX is going. They've also been very flexible about minimal residual disease detection, which could shape the way we give adjuvant chemotherapy and protect a lot of people from excessive adjuvant chemotherapy. So I think in some of these ways, in coverage, they've been very forward looking.

Rick Gannotta: Yeah. Now Bruce,

uh, lemme ask one question, a follow up on that. Are they specifically focused on one area? When you, when you look at it from a I guess specialty perspective?

Bruice Quinn: Oh yeah, sure. Their, their, their, their mandate is genomics. So it could be anything that touches genomics, but by default it's maybe 95%. Cancer there are a few [00:21:00] other very active areas like using DNA detection for transplant rejection. If that's something Nate is in Care DX is in Moldex has been very active in that area, but some work in infectious disease.

But you know, if you just pick diseases like pancreatic di like diabetes or something, or arthritis, there, there wouldn't be anything going on.

Rick Gannotta: Yeah, and I don't wanna be too critical of CMS, particularly when they're doing a good thing like this. But if you were to gauge the, I guess the, the pace of innovation through the Moldex program versus what's happening, let's just say in the venture space respect to the health sector, how are they tracking?

Bruice Quinn: Well, yeah, I can address that with, with data. They have a public database of all their articles and all their policy. Huge proportion of them are in cancer, as we mentioned, but also the frequency with which they open a [00:22:00] truly new area of coverage in a new disease with a new paradigm, with a new form of genomics That's extremely rare.

I don't know if once or twice a year or less. So there's a lot for tumor panels. There's a lot now for minimal residual disease, meaning circulating DNA, but just some brand new area. Very rarely shows up. You can scan them month by month by month, and there are new policies and there are very few brand new policies.

Rick Gannotta: So if you were a startup in the space that was looking at diagnostics, let's just say with a genetic twist to it, it would probably, you know, behoove you to get involved with mild duct, look at their data to line up and get further faster for a lack of a better term, with respect to, you know, crosswalk and reconciling

Bruice Quinn: Yeah,

Rick Gannotta: tracking and its potential returns.

Bruice Quinn: in some ways. The bottom line is the same thing that you heard [00:23:00] 30 years ago when I started working in med tech consulting and health policy and working at CMS. In the early two thousands, there was a cliche that if you're making a medical device, you wanna be sure to fit an existing code and not interfere too much with the physician's practice pattern.

I mean, we heard that 30, 40 years ago, and that's exactly what I just described 90 seconds ago on your podcast. You know, if you fit under an existing LCD an existing coverage policy in one of these major areas like tumor gene panels, you have pretty clear sailing. If you do something that's totally out of the box and you're striking across the ocean to a new island.

Then it's much, much harder to get, to get traction, and there's a lot more suspicion as to whether your thing will actually work in effect, actually affect healthcare and actually improve outcomes.

Rick Gannotta: Let me hone down clinically on what's happening in the neuro Alzheimer's space, both in the [00:24:00] diagnostic side. There's a lot that's out there right now. Recent, I think certainly articles that I've read on some of the specificity that's coming through. What are your thoughts on that, Bruce?

Bruice Quinn: Well, I, I, I, I'd take two entry points there. One is the thing that cm, the thing CMS. Starting under the Trump administration and now under the Biden administration has been really trying to improve the integration of chronic care. That's a big task. You know, it's like saying you wanna improve education in the United States or improve transportation in the United States.

A huge task, but they're really trying to improve chronic care, and they did that first probably within something called oncology care Model, where they're trying to give some extra money to integrate oncology care.

Not terribly successful. Nonetheless, they have now expanded that to chronic diseases in general.

There are special programs for chronic disease management, especially from the perspective of primary care. And there are some special programs like Guide GU, UIDE where IDE stands for [00:25:00] improving the dementia experience. It's providing some funding for respite care, for caregiver training, for other kinds of reimbursement, and it's just, it's just launching now.

So it's a, it's a new program. It plans to be an eight year program, but 20 years ago or 10 years ago, we would've said that Medicare is horrifyingly fragmented from the perspective of fee for service, Medicare, and integration for chronic disease. There was a. Dumpster fire but now they're really trying to affect that.

Interestingly, as we have over half of the Medicare patients and Medicare Advantage plans, this program guide, which is so exciting, is only for the fee for service 40 or 50% of patients. And there's nothing equivalent on the Medicare Advantage side.

Rick Gannotta: That doesn't seem to make sense at all. If I'm trying to manage the clinical trajectory of a, of a patient, say, who has dementia, I.

Bruice Quinn: Absolutely. It, it, it does seem kind of [00:26:00] illogical. And then in the area of diagnostic tests, back when I was an Alzheimer's disease researcher in New York, in the nineties, every six months, somebody would talk about a new, highly accurate Alzheimer test, blood test, or CSF test. None of them from the nineties to the two thousands to 2024 ever took off until I think now, and we now have technology and monoclonals and precision that will let us measure tau especially phosphorylated to tau isotopes in the serum and with, you know, 80, 90% accuracy for diagnosing Alzheimer's disease.

That's right now at the level of coming out as favorable editorials and pivotal papers of, you know, the accuracy in hundreds of patients that should be moving into coding and coverage and reimbursement over the next 6, 12, 18 months. And it's important too, in the perspective of the antibody amyloid drugs and giving them more accurately.

Rick Gannotta: [00:27:00] And Bruce, how does that crosswalk to the genetic side of things and the specific genes?

Bruice Quinn: The genetic helps too. And some of the offerings that are coming out integrate the plasma au, the beta amyloid and the a OE genotype, which is the main gene that people talk about. There was just a paper this week that homozygotes for a OE four should really be viewed as a class of disease under themselves.

That makes the genetics even more important. Up until today, I think both Medicare and private payers have had usually the position they don't pay for a OE four testing even in Alzheimer's disease. And that should be another wall that comes tumbling down pretty soon.

Rick Gannotta: Yeah. Bruce, this is a, this is a tough question. I'm sure you're not asked it enough, but what are we not getting reimburse? What would we order more if we were getting sufficient reimbursement for it as clinical [00:28:00] providers?

Bruice Quinn: Well, I think there, there's definitely some room for improvement in the area of pharmacogenetics. Pharmacogenetics has suffered from I think, height for 20 or 30 years, but there are clearly areas where it's useful. The, the field suffered and, and I've seen this in other areas. Some will say there's, I.

$500 billion of adverse drug events, therefore do pharmacogenetics. And that's not convincing to anybody who's a decision maker. But that would be an area that I think would definitely be useful. Management of prostate cancer with either a more sophisticated serum tests or more sophisticated genomic tests would be a hu is starting to be a huge advance.

There is just a paper, I think in Jam or New England Journal about using the four protein test instead of just PSA and what the improvements would be if that was rolled out widely. So I think we've got some major areas, you know, diagnosing early kidney disease, managing prostate cancer better, where you've [00:29:00] got that range of aggressiveness that's important to get a handle on.

Pharmacogenetics, as I mentioned, those are some of the first things that come to mind.

Rick Gannotta: Yeah, let me on the prostate cancer example, how far off are we, how long would it take before that becomes practice first? I mean, is it proven? Is it efficacious? Is it, I. Makes sense within my diagnostic milieu to, to order it. Do I understand it? If I'm a urologist, how far off are we in terms of years before that becoming reality?

Because the assumption here, and by the way, these are all highly loaded questions. The assumption here is, hey, you're going to, be more specific with surgery. You're gonna be much more precise with when someone needs surgery and also knowing when they don't.

Bruice Quinn: Sure. I think there's, there's sort of a sliding scale for, for how much data you need to move forward. The accuracy data has been there for [00:30:00] 10, 12, 14 years. I. That you can do these molecular tests or multi-panel proteomic tests and the accuracy is substantially better. So there, it's a question of whether you feel confident actually bring it into clinical practice or not, or how much outcome data do you need?

How much clinical data clinical utility data do you need? Which means actually using the test in practice with patients and watching what happens over one or two years. And those are the sort of papers that are coming out now. The positioning guidelines is not bad. You know, these tests may be recommended for patients in borderline situations and so on.

So there's definitely some positioning and guide guidelines now. But I think it's, you know, classically the medical adoption cycle is kind of slow, but I think it's all the pieces are there to move forward with this more accurate landscape of prostate cancer therapy.

Rick Gannotta: And I think back to the AI piece, when you synthesize it together and you have you know [00:31:00] artificial intelligence supplied to it, machine learning component, clearly it changes. I would think, again, the velocity of those decision points. I.

Bruice Quinn: Yeah, and it, it, it's, it's you know, we were mentioning virtual twins earlier. There are capabilities for modeling that, that become more, more powerful. I.

Rick Gannotta: Yeah, absolutely. Let me, as I, as we kind of get to, towards the end of the the show here. Let me ask about some special topics, one on the regulatory landscape. Anything that is top of mind for you when you scan. I. That, you know, I know this is, it's always one of those, those pressure points that are out there for anyone who's a startup or an existing company that's out there.

And we have a new, election cycle coming up. We got presidential election happening. What are your thoughts on elections, their impact on overall health [00:32:00] policy? How does that trickle down to the regulatory landscape and CMS. I know there was a lot there, Bruce.

Bruice Quinn: Well, let's start with the election which I, I think as of now in May, has to be viewed as, you know, very much up for grabs. But the Trump administration, in terms of CMS management and CMS innovation, I think was quite good. There were some very nice things that the Trump administration did, leaving entirely aside, 2020, which was the covid year from February forward, but the first three years of the Trump administration, and there were some very good innovations going on.

We had an what I, who I felt was an excellent. Secretary of Health in Alex Azar, we had, who I believe proved to be a very good leader of CMS cma, Verma, and, you know, innovative things were happening. So I think in terms of just a silo around [00:33:00] CMS where I work, either administration could be fine.

In terms of specific regulation. The FDA has brought out a final rule that within several years they will have essentially total control over lab developed tests which is a enormous change in the policy landscape. I. I think there are many things that could happen over the next several years.

If, you know, there's a saying in Hollywood that nobody knows anything. Nobody knows who's gonna be the blockbuster, nobody knows who's gonna be the star. I think if anybody predicts what the, what will happen with the FDA and lab tests over the next four years it's just, just too hard to predict. There are too many wild cards that could play out in different ways, but what they've proposed is that all locally developed, laboratory developed tests will have to have either five 10 K or PMA approval.

Within just years and they originally proposed that would cost $40 [00:34:00] billion, $40 billion over a few years, but they're now grandfathering existing tests, and that dropped the cost by about 90% to a few billion dollars over the next four years. It's unclear where you get all the regulatory professionals to do that.

It's unclear where FDA would hire hundreds of new staff with regulatory expertise and diagnostics. There are a lot of, I think, missing, missing pieces right now. there'll probably be legal challenges and those could tie the whole thing up in court for several years, but it's certainly is one of the things that investors are thinking about now.

Rick Gannotta: Yeah, that was my follow up. How does that, you know, impact, influence blunt, the investor community? The where, where, at least for me, I've been very bullish on the diagnostic space because I think there's so much innovation. A lot of that innovation's coming from the private sector. I.

Bruice Quinn: Yeah, for sure. The innovation, the fundamental innovation in diagnostics doesn't come from NIH as it might in some other areas. I, [00:35:00] I think it shifts the landscape of who's likely to be successful. It's no surprise, it would certainly help the biggest companies, the multi hundred million dollar companies with large staffs and lots of attorneys and regulatory professionals.

They would be able to thrive perhaps in, in, in this promised environment. So that's not bad. You could have more barriers to copycats as at least bad copycats couldn't enter the market. So I, I think there, it'd probably be a regime where the big get bigger. Just like in diagnostics today, you've got huge companies like Siemens, Abbott Roche, with, you know, dividing up 20, 30% of the market here, here and there to each one of them.

And so you'd probably have something like that in molecular tests where you wouldn't have 15 startups each on the market and each offering something under clia. You'd have a couple on the market and offering something, but then, then each one of them would have [00:36:00] twice as big a market. So it, it sort of balances out.

Rick Gannotta: Hmm. Lots to, lots to tackle there. Bruce, as we close up the show. I'm gonna put you on the spot once more. Give us your thoughts on, I'll stop short of saying predictions, but the trends better than directional. That's happening in the space across the board, the diagnostic space. But I want you to take a stretch also and think where do the greatest investment opportunities lie?

Is it genomics, the personalized medicine sector? Is it the application of ai? The genomics, obviously CRISPR side. What are your thoughts on that? Bring us home.

Bruice Quinn: Well, I think we need more precision diagnostics in some of these areas where the drug therapies are promise are, are new. And promise to be so influential. I meant an, I mentioned antibody drug cons, conjugates. There's also CRISPR mediated biotechnology therapies. [00:37:00] And having, understanding what the molecular options are to assign those better, that's the huge thing.

And it's not gonna be single genes. It's gonna be pathways probably. And, and so that brings in the AI or machine learning aspects of it.

Rick Gannotta: All right, my friend. So good to have you on. Great to see you. Dr. Bruce Quinn, a resident expert in all things that fall into the diagnostic and pathological world that's always influenced by health policy. Thank you, Dr. Quinn. Bruce. Great to see you.

Bruice Quinn: Thank you. Great to see you too.