Bobbi Pritt, M.D. (00:34):

Hello, I'm Dr. Bobbi Pritt, a clinical microbiologist and laboratory leader at Mayo Clinic, and your host for today's episode. I'm excited to be here today with Mayo Clinic Laboratories CEO and president, Dr. Bill Morice, and he's going to give us the latest news. Bill will also join me for the deep dive, where we'll talk about how collaboration is impacting diagnostics. So Bill, thanks again for joining us. It's great to have you as always.

William Morice II, M.D., Ph.D. (01:00):

Yeah, it's great to be here as always.

Bobbi Pritt, M.D. (01:02):

So, let's start by talking about what's new and noteworthy in clinical diagnostics. And there's actually a couple things that we wanted to talk about today.

William Morice II, M.D., Ph.D. (01:09):

Yeah, there's a few things that have been in the news, some close to home, some like more kind of future casting, if you will. It was really good to see that not only was a bill passed to keep the government funded, but that some of the things that you and I talked about in the past were included in that bill, which had to go back and forth between the Senate and the House. And that includes some PAMA relief, including that we won't see cuts in the clinical lab fee schedule before the end of the year, as well as some other reporting changes and things that will make living with PAMA as it's written much easier, I should say, or make it more livable, I guess, more workable for labs. Not to be confused, of course, with legislation to actually reform PAMA. That's separate. So, this is still PAMA, but at least we have some relief going forward for the rest of this year. So, we won’t be kind of living bill to bill, if you will, through the end of 2026.

Bobbi Pritt, M.D. (02:00):

Right. That was definitely a relief, yes.

William Morice II, M.D., Ph.D. (02:04):

Definitely a relief. You know, I think for all of us the decision to fund for Medicare to cover multi cancer, early detection tests, you know, these cancer screening tests that are out there that labs are bringing out, that was big. And then also interesting was the FDA. Haven't forgotten about the FDA, that's on the payment side. You know, the FDA coming out with clarification on wearables and that they're classifying many of them as wellness devices as opposed to medical devices, which means that things like your Apple Watch  and WHOOP and other things that collect —  your Oura ring — collecting biomedical data, heart rate, some other things, that those are really considered wellness devices, much lower regulatory bar for them to actually introduce that data or give you that data to think about and act on. So, those are all some pretty substantive topics in the government.

Bobbi Pritt, M.D. (02:54):

I was really interested in all of them, of course, but the wearables was interesting because you and I had talked about that when we were kind of forecasting what we're going to see as a trend to expect this year. And as you mentioned, there's a whole bunch of different ways you could wear these things. You know, there's not just smart watches, but now there's these rings, patches, sensors, and it's really interesting to see that they're going to be in this wellness category, which probably will open up more options and make it easier for manufacturers to get them on the market.

William Morice II, M.D., Ph.D. (03:25):

Yeah, for sure.

Bobbi Pritt, M.D. (03:26):

Yeah. What are some of the things that will come out of this, and how do you think leaders anticipate this impacting the industry?

William Morice II, M.D., Ph.D. (03:33):

I think it's twofold. Number one, it's also interesting that even continuous glucose monitoring, which if it's not used in the setting of diabetic care, is always considered a wellness device. So it really opens the door for those who are in the wearable space, all the companies we just mentioned, to really start positioning themselves to be more at that intersection between wellness and healthcare. And I do think it will also continue to spur the use of AI, which is in and of itself becoming such a generic term for a lot of different machine learning and computational tools. But, since these generate continuous or near continuous data, more AI applications that might signify to you as a wearer of one of these devices, something about your health. So, I think it's really going to unleash this kind of intersection between wellness and health; diagnostics being right at the center of it.

And for us, it'll raise questions about, how do these crossover? Because as a wellness, that also means that they're really not supposed to be used like in medical decision-making. That's why the important distinction for the glucose continuous monitoring, right? You're not supposed to use insulin dosing for it. So that means, we'll have to continue to clarify things for individuals. I might even say patients, but for people, what makes data actionable versus not from a medical healthcare perspective. And then for us as laboratorians, how do we need to start thinking about confirmatory testing for some of these observations, some of which might be made by wearables.

Bobbi Pritt, M.D. (04:59):

Yeah, I was thinking the same thing. That's great that you have a device that gives you some sort of figure, some sort of result, but then if it's not supposed to be used for medical decision-making, then for actual patient care, you're going to need to obtain an actionable value. So what is that going to be?

William Morice II, M.D., Ph.D. (05:15):

Yeah, I think back to like the days of COVID and you know, a lot of different wearable devices. I remember the, I think the Oura ring got a lot of notoriety. One of the major sports leagues was using it, I think, to monitor for fever, to see when someone needed to be tested. So even in the infectious disease world, maybe this will spur people, you know, even home testing, and it'll be just really interesting to see. There's no doubt.

Bobbi Pritt, M.D. (05:37):

Yeah, I agree. And impact industry, I would think that this would increase innovation and investment. Is that your thought as well?

William Morice II, M.D., Ph.D. (05:44):

Yeah, I think so. It'll increase that. It also portends something you and I discussed, and that is the fact that healthcare is so heavily regulated. It's really been relatively insulated from disruption, but these are all disruptive things that are now encroaching upon what you and I have spent a career doing. So we need to start thinking about that now, and what's the best way to make that innovation useful for patients and useful for society.

Bobbi Pritt, M.D. (06:09):

Well, these are great news topics, Bill. Why don't we now transition to our deep dive?

William Morice II, M.D., Ph.D. (06:14):

Sounds good.

Bobbi Pritt, M.D. (06:20):

Welcome to today's deep dive. We're going to go beyond the headlines with Dr. Bill Morice to explore how collaborations are helping drive transformation in clinical diagnostics. As we've discussed in previous episodes, Mayo Clinic Laboratories has pursued new collaborations as part of its transition to a platform company. And I thought it would be insightful to explore more about the benefits of this approach. So Bill, we're gonna continue our discussion now. Let's talk about this interesting topic. Why is collaboration and clinical diagnostics such a powerful driver of innovation?

William Morice II, M.D., Ph.D. (06:55):

Well, it's a great question. It's one that certainly that I think about on an almost daily basis, if not a daily basis. As we have looked to transform Mayo Clinic Laboratories from purely a pipeline business model, meaning that the primary and sole function of Mayo Clinic Labs was to get tests to people like you and me that were working within the academic Department of Lab Medicine and Pathology at Mayo Clinic. In addition to doing that as our strategic imperative, also thinking about how we collaborate with others who are creating diagnostic capabilities that need access to patients and patients need access to them, but in a way that really helps inform their care by providing holistic diagnostic solutions. I mean, that's really the intent of Mayo Clinic Laboratories, is by opening up the aperture by which we interact with patients and laboratories, that we can help orchestrate an ecosystem that's really centered on the patient. So very much in keeping with our core value, our core mission of the needs of the patient come first. So, that can spur innovation in a lot of different ways. I saw at one point a diagram that showed like innovation, there's actually like 12 different ways to innovate. So there's many different ways we can even think about how this transition can spur innovation.

Bobbi Pritt, M.D. (08:06):

Yeah, that's great. And you know, Mayo Clinic's transition to this platform company has really shaped how we talk about collaboration even. Maybe we should just remind listeners what we mean when we talk about a platform. You've mentioned it a couple times already, Bill.

William Morice II, M.D., Ph.D. (08:19):

Yeah, so essentially, people like to use Uber. I think Uber is a very tangible example. You know, Uber doesn't own any cabs, right? It doesn't, but it provides a virtual space where someone with a car that wants to give someone a ride for money can find people that need a ride from point A to point B. And if it works for both parties, they make an agreement at a preset price, and then the trip happens. Your Uber trip happens. And so the concept then of a platform for Mayo Clinic Laboratories is that in addition to opening up our laboratories to the outside world with a focus on the real esoteric and differentiated testing that we perform at Mayo Clinic, as well as the knowledge that we have around how to consider the use of tests and delivery of care, we now can have other laboratories, other purveyors of diagnostics that meet patient-centric quality value proposition, they can also be available to patients in hospitals through Mayo Clinic Laboratories. Over time what this will do, hopefully also, is allow us to reach more patients by having other channels, right? That's really the intent is to keep what you and I do on a daily basis in terms of keeping the needs of the patient first and those Franciscan values of compassion, healing, teamwork, and kind of broadening our ability to deliver those services by bringing others in, if you will. So going back to innovation, I think that spurs innovation in a lot of different ways.

Bobbi Pritt, M.D. (09:45):

I agree, and it makes sense. Of course now, we're not opening up an Uber business, so maybe we should talk about some specific examples. Can you share a few of collaboration at Mayo Clinic Laboratories?

William Morice II, M.D., Ph.D. (09:57):

Yeah, I'd love to. Then we can kind of thread that back into even to the innovation piece as well, right? So, two things. Number one, one of the early examples that has really paid dividends for all involved is our work with the Alzheimer's disease testing company C2N. So, C2N is also a spin-out of an academic medical center, in this case, Washington University in St. Louis. It uses a mass spec-based approach to look for blood-based biomarkers for Alzheimer's disease. They were early innovators in this space. They had this testing capability where we did not. We have a lot of expertise on the diagnosis of Alzheimer's disease and other cognitive and neurologic conditions, but we didn't have a test like the C2N test. And so, we were able to bring that test to market through our neurology sales force at Mayo Clinic Laboratories.

One of the premises of a platform company is that by having multiple offerings, you can get, in this case, more patients interacting with and trusting Mayo Clinic Labs. And that actually played out. So we've seen great demand, both for the test offered by DLMP as well as for the C2N test. They really have sort of different applications, if you will. They appeal to different practitioners out there. So both have been highly successful.

Then from the innovation side, part of actually having both access to the C2N test as well as our own Lumipulse assay, did give us some insights to the neurology practice about how they compared the performance of each. And more importantly, by having kind of a broader view of how these tests are being used in practices outside of Mayo Clinic, has continued to drive innovation within DLMP in terms of test development and other tests that we need to bring up. So, there's innovation in terms of the care delivery that happens as well as what you and I think of more traditionally as innovation. That is, you bring a diagnostic up, it almost always shows where you need another diagnostic capability. So it's really accomplished both.

Bobbi Pritt, M.D. (11:55):

Well, it really does open up some opportunities. Say you have a company that, like C2N, comes up with a really novel test that's not available and perhaps it's patented technology, this is a way then for Mayo Clinic Labs to open that testing up to more patients, but also still provide the full spectrum of all of the testing we perform within the Department of Lab Medicine and Pathology, including the serious and complex. So, it's a nice model and a nice example of platform. Any other examples you want to highlight?

William Morice II, M.D., Ph.D. (12:24):

There are a few others that we already have executed. One is with Lucence, which has, their diagnostic test, meaning a test to help guide therapy, in this case, in cancer. It's unique in that it uses both circulating DNA as well as RNA. So, it's one of the more complete tests, if not the most complete test out there. Again, it's not something we have within our department. So, it's another example where we're now going out, understanding how the oncology community writ large wants to interact with these tests, what they're looking for from these tests, how we need to continue to innovate to make these tests available. So, that's another example and we'll continue to see these grow, I think, as more and more of these tests come forward. Many of them, as you said, proprietary so we can't offer them from DLMP.

And what they really do is they contribute to what I think is the most important thing that we do, in addition to the tests that we provide, and that is the knowledge on how to use them. And so again, you and I have both been in situations where patients have had a lot of diagnostic information created outside of our walls, and then the case is sent here. Either the patient comes with the materials or the case is sent consultation, and you're trying to put together the puzzle with pieces of information which are partial. And this way, by having all the testing coming through Mayo Clinic Laboratories and having us interact, we can understand and create better answers for patients and really think about all the things that go into making a diagnosis and how we can help guide that.

Bobbi Pritt, M.D. (13:48):

Yeah, that's great. And I love how you tie it back to the patient because that's really what this is all about.

William Morice II, M.D., Ph.D. (13:53):

Absolutely.

Bobbi Pritt, M.D. (13:54):

Well, this is a great discussion, Bill. So, thanks for joining me for both our news and our deeper dive, and I'll look forward to future discussions.

William Morice II, M.D., Ph.D. (14:01):

Yeah, I will too, as always.

Bobbi Pritt, M.D. (14:09):

Let's wrap up with the top takeaways and how to learn even more on the topics we discussed. In our news summary, we talked about some changes to PAMA legislation and also the FDA's approach towards wearables, and we will include some resources for you to learn more. And then in our deep dive summary, Dr. Morice stayed on and we talked about the power of collaboration to create a more holistic approach to diagnostics and drive innovation. The show notes include a few articles and podcasts with practical advice any leader can use to establish meaningful collaborations.

Thank you for joining us today. If you haven't already, make sure to subscribe so you never miss an episode. For our next episode, Dr. Matthew Schultz will be sharing a unique story about a test for a genetic condition caused by a recently identified peripheral neuropathy. I hope you'll join us.