Bobbi Pritt, M.D. (00:04):

Hello, I'm Dr. Bobbi Pritt, a clinical microbiologist and laboratory leader at Mayo Clinic and your host for today's episode. Thank you for joining us for our first episode of the year. Dr. Bill Morice is back again to discuss some trending topics. Then, Dr. Matt Binnicker will join me for a deep dive where we'll talk about how you can accelerate innovation while keeping quality and safety paramount. But let's first start with Dr. Morice. Bill, welcome back.

William Morice II, M.D., Ph.D. (00:31):

Yeah, it's great to be back for 2026.

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

Absolutely. Another year. Happy New Year.

William Morice II, M.D., Ph.D. (00:36):

Happy New Year to you as well.

Bobbi Pritt, M.D. (00:38):

So we'll start off by visiting what's new and noteworthy. And you know, Bill, we just recently talked about industry trends, and you were quoted in a really nice article in 2025 about industry trends. And the last time that we spoke, we covered some of those. But one thing I noted that we didn't really get into was direct-to-consumer trends. So, I thought that would be a really good topic for today.

William Morice II, M.D., Ph.D. (01:03):

Yeah. All the way back to last year, that article. But certainly I think it's actually kind of timely that we didn't talk about the direct-to-consumer trends because I do think with the news about some of the changes in governmental subsidies for personal health insurance, it's predicted that healthcare costs will go up for individuals, which will probably drive a whole other wave of interest in consumerism, if you will. But really paying close attention to what they're buying for their health and what they're paying for their healthcare.

Bobbi Pritt, M.D. (01:30):

And you really can't go on anything these days ― social media, TV, radio ― and you hear these direct-to-consumer ads, and I think they're increasing even more. I've seen some for testing. So maybe you could just start by sharing with our listeners some examples of direct-to-consumer trends, especially as they impact laboratories.

William Morice II, M.D., Ph.D. (01:50):

Yeah. Well, it's interesting because when we think of direct-to-consumer, it almost has a pejorative name in healthcare that we wouldn't be trying to just get on the shill, if you will. But really this trend goes back to COVID, right? Where, when you and I were doing these “Answers From the Lab” podcasts and there was a lot of interest obviously in at-home testing at that time, a lot of companies popped up because we thought this was going to be the future, that people would do most of their infectious disease testing for things like common respiratory viruses at home. That groundswell really didn't take off and receded. But on its heels, we do see a different kind of consumerism coming forward, and it really is a lot of its function more just on general health and wellness and screening. And I think this is great.

William Morice II, M.D., Ph.D. (02:31):

I think actually if we can get more kind of screening technologies and health and wellness technologies and tests out to individuals such that more use them, then really it will overall improve health and healthcare. The perfect example obviously would be Exact Sciences’ Cologuard test. It was a real groundbreaker in terms of, you know, at-home testing that you still send into a lab for colon cancer screening. And I think that's going to be a big bulk when you ask about what it means for the labs. That'll be part of it ―part of it will be collection devices that are done at home but still sent back to a lab for testing.

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

Yeah, and you brought up a good point. There's differences between at-home collection, where you still send to a laboratory for testing, versus at-home collection and testing. And there are options for both, and I certainly have seen them. And for laboratory, I really do, like you, appreciate the emphasis on wellness, as long as it's not overdone. Because sometimes I see options for people to get a hundred different tests performed. But it is nice, it is putting more of the emphasis on the patient and giving them more the responsibility to take responsibility for their own care.

William Morice II, M.D., Ph.D. (03:39):

Yeah. And I think really the at-home testing or direct-to-consumer testing kind of will fall into two categories at least, or maybe even three. One would be sort of physician-directed but at-home testing, that could be really helpful for patients that are in really test intensive healthcare delivery situations, such as post –transplantation, where there's a lot of routine testing that is part of that. A lot of times, patients have to drive several miles to go to a care facility just to get their test drawn. And then there's also going to be the wearables, which are kind of at the one end of the spectrum. You know, not even a test at all in the traditional sense, and then back to the self-collection. I think we'll see all three in this coming year all kind of come forward and so it'll just be more options for patients and more things for labs to think about how they support diagnostics that are not within the lab but kind of peripheral to the lab but still need to be incorporated into healthcare.

Bobbi Pritt, M.D. (04:29):

Yeah, I agree. So what would the challenges be that you foresee, Bill, in this area?

William Morice II, M.D., Ph.D. (04:34):

Well, I mean it's going to fall down to the individual technology almost. But I think the big ones are, number one will be, just the data, right? How does data created outside of the healthcare environment make it in, you know, the lab data ― we don't want to see more fragmentation where the patient has their own data around their diagnostics, but it's not coming into their overall health record. I think there'll be concerns around data privacy, because a lot of these things again, will be out there in the public domain, and then there'll be continued concerns or questions around quality and reimbursement. So are the tests of sufficient quality? Are the collection devices of sufficient quality? And then who's going to pay? I mean that's the big thing. A lot of these right now are as out of pocket, meaning the patient has to pay. So we'll have to see. Those would be some of the barriers I think that we're going to have to overcome if we're really going to see real growth in this area.

Bobbi Pritt, M.D. (05:21):

Yeah. Well, it's a very interesting topic dynamic for sure. You and I'll have to keep an eye on it in 2026.

William Morice II, M.D., Ph.D. (05:27):

We'll put it on the list.

Bobbi Pritt, M.D. (05:29):

Absolutely. Thanks again, Bill, for joining.

William Morice II, M.D., Ph.D. (05:31):

Oh, it's my pleasure. I look forward to the next time.

Bobbi Pritt, M.D. (05:38):

Welcome to today's deep dive. We're going to go beyond the headlines with Dr. Matt Binnicker, Mayo Clinic Laboratories’ chief scientific officer. Together, we'll explore the accelerating pace of innovation in diagnostics and how we can keep patients safe and deliver accurate results as the industry moves faster than ever. Thank you for joining me, Matt.

Matthew Binnicker, Ph.D. (05:59):

Hey, Dr. Pritt, always good to be back.

Bobbi Pritt, M.D. (06:01):

Yeah, it's always great having you on our podcast. So, I have a number of questions for you today. Let's start with maybe a straightforward one. Well, maybe it's not straightforward. What is driving the acceleration of innovation and diagnostics?

Matthew Binnicker, Ph.D. (06:15):

Yeah, I think there's a few reasons why we're seeing such an accelerated pace of change in diagnostics. First and foremost, technology is accelerating and changing and improving faster than we've ever seen it change before. That's because technologies and the companies that are working on these are just moving into such an innovative space and evolving at a pace we've never seen before. We're also seeing, I think it's coming out of the pandemic, raising expectations from both patients and their physicians on new technologies, new diagnostics to improve healthcare. Again, during the pandemic we saw new tests coming out at a rate that we haven't ever seen before. And so that set a new baseline in terms of expectations. So that along with just the technology that we have available to us today, I think, is really two of the main accelerators behind the change in diagnostics.

Bobbi Pritt, M.D. (07:23):

Well those are great points and the technologies we have these days are just amazing and they seem like they're changing. Every week there's a new AI program, or now we're talking about agentic AI. So, you published a recent article where you talked about the scientific process and how it's our most important safeguard, and that would be for patient safety, for keeping the field safe for our patients. Why is that so important?

Matthew Binnicker, Ph.D. (07:50):

Yeah, I mean the change in healthcare, the change and accelerated pace in diagnostics, those are good things. But we have to improve, and we have to iterate and have those evolving diagnostics along with certain safeguards in place to ensure that there's trust from our patients and that there's safety. And the good news is I think we can accomplish both. I think we can accomplish rapid pace of innovation and diagnostics while maintaining trust and safety if we follow a few important steps. First and foremost, we've always used the scientific method in healthcare and medicine and science and research to help ensure quality and safety, and that has a foundational role in diagnostic innovation as well. So what does that mean? It means that while we're innovating, we've got to design our experiments to test and not confirm a hypothesis. So really pressure testing new innovation throughout the process continues to be important. And what we want to avoid is that potential danger of saying we've got to rapidly innovate, and so we've got to design our experiments to confirm a preconceived notion. That's what we have to avoid. We have to pressure test our hypothesis throughout the pace of innovation.

We're generating so much data today as well with these new technologies and tools. And we have to be really disciplined with the data that we generate and assess our data with an objective mindset. And I think if we keep patients at the center of our decision-making and at the center of the data that we're evaluating, that also helps to ground us and keep that as a quality and safety check on everything we're doing.

And then the last point I'd make before we move on to the next question, is that, to accelerate, we have to work in new ways. Many times in research and in diagnostic innovation, companies and healthcare institutions have completed the process or work in a sequential, step-by-step fashion. And that continues to be important. But sometimes we have to finish those important steps of the scientific process in parallel, and that allows us to get important work done more quickly. And you have to design your experiments in the right way to be able to accomplish that. But it can be achieved, and it helps us to reach our endpoint in a faster, more rapid timeframe.

Bobbi Pritt, M.D. (10:33):

Yeah, that's a good point Matt. And I like how you said it's about the science. We're scientists, as laboratory leaders, and we can't forget the scientific process. And then of course, keeping the human in the loop, making sure that we're keeping it patient-centered, those are all important things. It doesn't change whether we're talking about agentic AI or just validating an immunoassay, for example, like a lateral flow assay. Well, what other strategies help balance that speed and quality?

Matthew Binnicker, Ph.D. (11:01):

Well there's been so much discussion and focus on artificial intelligence over the last few years, so I want to spend just a minute talking about that. AI and data analytics is really the next frontier in allowing us to rapidly get answers for complex questions, including patient disease and making their diagnoses. But with artificial intelligence comes a whole new level of responsibility in starting with clear, measurable questions, and again, avoiding those predetermined conclusions if we use data sets to help train our AI algorithms that are biased. And what do I mean by that? It means taking data only from a certain geographical region, like the Midwest in the U.S., where you live, and then applying that AI algorithm to patients all over the world. That won't generate high-quality results because we know there's a lot of variability in patients throughout the world. So, we have to design our experiments to include patients from all the geographic locations, all the ethnicities, races, genders that we plan to include for patient purposes, to train that AI algorithm to generate the safe, quality results for patient care. So that's a really important step with all of the data and the utilization of artificial intelligence, is making sure we're really assessing how it's going to be used, and then again, pressure testing it against those use cases.

Bobbi Pritt, M.D. (12:44):

I agree completely. You know, I just came back from London, England, where I was at the 12th Digital Pathology and AI Conference in Europe, and they were talking about all of these things and I actually had the honor of presenting some of the work we've been doing at Mayo Clinic, and all of the issues you just mentioned came up. We are still talking about this as we should be in the field, and there's some areas that we're still trying to work out ― how do we use AI and big data with discipline? But going back to those founding principles of keeping the patient in mind and being good scientists and really accurately applying the scientific method. Those are all the basic principles.

Matthew Binnicker, Ph.D. (13:24):

Yeah, absolutely. And I'd also say that the regulatory process has been a key foundational step in diagnostics for years, and it will continue to be. And for us to continue to innovate in diagnostics at the pace that is being expected of us, we're going to need to, one, understand the regulatory process better than we ever have before. Two, partner with those in the regulatory industry, such as the Food and Drug Administration and our state regulators, so that we are aligned and seeing the issues from the same perspective, having discussions early on so that we can help remove barriers and roadblocks before we encounter them, and then designing a reproducible framework for how we address the regulatory requirements so that we're not redesigning the wheel every time we're coming up with a new test. So again, partnering with, having conversations with those in the regulatory industry because ultimately those steps are in place to ensure quality and safety. And so, we need to do everything we can to meet those requirements while doing it in a timely and rapid fashion.

Bobbi Pritt, M.D. (14:43):

I completely agree. Well, Dr. Binnicker, as always, it's a pleasure having you here with us talking about these important issues. I'm sure we'll have you again in the future. I'll be looking forward to it.

Matthew Binnicker, Ph.D. (14:55):

Yeah. Thanks again for having me back.

Bobbi Pritt, M.D. (15:02):

Let's wrap up with the top takeaways of how to learn even more on the topics we discussed. In the news, Dr. Morice and I discuss direct-to-consumer diagnostics, exploring what's fueling their growth and what challenges lay ahead. In the show notes, you'll find links to the article we mentioned and our December episode on 2025 trends to learn more. Then, Dr. Binnicker joined me to discuss how we can accelerate innovation while safeguarding quality and trust. My biggest takeaway is the importance of staying anchored to what has always been our guiding principle, the scientific process and what's best for the patient. For more strategies and insight, check out the link to Dr. Binnicker's article in “Fierce Healthcare,” which we've included in the show notes. Thank you for joining us today. For our next episode, Dr. Morice and I will dive into what we anticipate is ahead for our industry in 2026. I hope you'll join us.