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, Dr. Bill Morice is back again to discuss recent topics in the news, and then he'll also join me for the deep dive where we will reflect on some of the advancements and trends we saw in clinical diagnostics this year. So Bill, as always, welcome back.

William Morice II, M.D., Ph.D.  (00:28):

Yeah, as always, great to be back.

Bobbi Pritt, M.D.  (00:30):

Let's start with the news. Let's visit what's new and noteworthy. You know, there's a number of things going on, but I think respiratory viruses would be a good thing to talk about, ‘tis the season. And one of the things that caught my eye as a clinical microbiologist is this new subclade K variant of influenza, which is a more severe flu variant and it's spreading in the U.S.

William Morice II, M.D., Ph.D.  (00:54):

You know, it's funny to think back. We just had the five-year anniversary of COVID, and this was on the news all the time, variants and strains and all these sorts of things. We got fatigued from it. But the reality is that that's the way these viruses work, as we said at the time. And so, we just had to maintain vigilance because they're always adapting and changing. And sometimes those adaptations make us either they're more transmissible, make you more sick, or both. So we have to watch out. And it seems like there's some of that happening now with influenza.

Bobbi Pritt, M.D.  (01:21):

Yeah. And they’re RNA viruses, so their proofreading mechanisms are not very good, and they're prone to mutations, and some of those mutations make them more virulent. So right now, a mutated strain of influenza H2N2, which is one of the predominant strains that circulates, it's known as subclade K. It began spreading across the northern hemisphere this fall, still spreading. Now, it's been in the U.S., Canada, Europe, the U.K., parts of Asia. The symptoms are about the same: fever, cough, runny nose, aches, and chills, but could be more severe. And it's the typical risk groups that you worry about for severe influenza, young children and the elderly. They can really easily get dehydrated, have a higher fever, maybe be hospitalized. Now the activity in the U.S. is currently low, but you know, it's going to start picking up, I'm sure. So this coming into the holiday season is what we should be thinking about is, how do we protect ourselves? How do we protect our families and our loved ones and our friends?

William Morice II, M.D., Ph.D.  (02:25):

Yeah. Influenza is no joke. I remember I used to be kind of lackadaisical, for lack of a better word, about getting vaccinated. And then one year, I got influenza and it was horrible. So even if you're not in a high-risk group, it can be a very debilitating infection. And the good news is that the same things we've talked about for prevention still hold true here. There's vaccination. It's important to get vaccinated to protect you and protect you from spreading it to others. And there's masking, and there's also avoidance. If you know you're sick, maybe begging out of the family gathering is a good idea. And thinking about masking during travel. Air travel is back to all-time highs. It's never a bad idea to think about pulling that mask out of your bag and putting them back on when you're on a crowded airplane.

Bobbi Pritt, M.D.  (03:10):

It's so true. I just got back from an international flight and the whole time I was there, I was vigilant about hand-washing. I was traveling with some family members. We were constantly pulling out the hand wash, the hand sanitizer. So being very diligent. And then of course, if you're starting to feel unwell, know when to get tested. If you're going, you come home, and now you're not feeling well, stay home or wear a mask. And then the other thing I'd recommend is, of course, get up to date on your vaccinations. When you go to get your vaccine, ask your healthcare provider, “Are there other vaccines that I am behind on?” Maybe it's time that you get your RSV vaccine, or maybe there's some other vaccines. So it's just a good chance to kind of get up to date on everything.

William Morice II, M.D., Ph.D.  (03:55):

Right. I totally agree.

Bobbi Pritt, M.D.  (04:02):

All right, so now changing gears, let's go into our deep dive section. We are now going to go beyond the headlines and reflect on some of the more significant advances in our industry this year. And Bill, you probably remember at the start of 2025, you shared some predictions for the year. I don’t know, do you remember that far back? It seems like forever ago.

William Morice II, M.D., Ph.D.  (04:25):

Like forever ago.

Bobbi Pritt, M.D.  (04:26):

I thought it would be interesting to revisit those predictions and see how they played out.

William Morice II, M.D., Ph.D.  (04:31):

Yeah, accountability. Accountability session for my predictions. Let's do it.

Bobbi Pritt, M.D.  (04:35):

So I'll remind you, you had predicted that AI, digital pathology, and mass spec would be areas of significant technological advancement. And that seems pretty accurate to me. But I'm curious, is there anything that surprised you about the technological advancements this year?

William Morice II, M.D., Ph.D.  (04:54):

No, but I think there probably are some headwinds. We saw the technological advancement and some that we didn't anticipate as much. So I mean, digital pathology is still expensive to install and institute. More and more places and practices are going to digital pathology, but it's still kind of on a relatively modest up ramp. And likewise, the AI tools that assist in pathology interpretation are also kind of on the up ramp and haven't really taken off yet completely. But those things are coming. I think when I think unanticipated headwinds, a lot of it is probably just in AI, the uncertainty around reimbursement. I just was in a meeting with people from Washington, D.C., last week, and they talked about how this administration's not particularly enthusiastic about paying for AI diagnostics as separate entities.

So we'll see. But definitely we've moved from interest to an expectation that these tools are going to get introduced into clinical workflows, both in the lab and outside the lab. I think mass spec for sure. I mean, Roche is still looking to launch their instrumentation in the U.S., but they have that automated mass spec that has drawn a lot of interest when they've been showing it at ADLM and European Hematology Association, other meetings like that. So, I do think mass spec is an area that's definitely kind of on the come as they say.

Bobbi Pritt, M.D.  (06:18):

I agree. And you know, the other thing we talked about was regulation and reimbursement, but really the regulatory environment and the uncertainty in the regulatory environment. And I would say some uncertainty still remains. But we did get some progress. To think about all those times we talked about LDTs, and now we're talking about the potential alternative to PAMA still. So what were your takeaways from that, especially with all the work you do with ACLA?

William Morice II, M.D., Ph.D.  (06:46):

Well, you know, that's an interesting one because, gosh, March seems like so long ago. But to have American Clinical Lab Association, ACLA and AMP both challenge the FDA final rule in court and have the court rule that LDTs could be regulated as medical devices by FDA and have the court overturn that or support the plaintiffs to say that lab-developed tests are not medical devices. That was a great victory, right? It is something we had been worrying about for years. It also opened the door to a couple of other things that maybe we didn't anticipate. And one is that the regulation of software as a medical device is something FDA already does. And so now does their attention pivot more towards the thing we just talked about, AI? There's a lot of churn around AI now, too, both its regulation and its reimbursement.

I think the AMA was suggesting that maybe only AI would be paid for if it was FDA cleared, which is probably not a great idea. So that's one. The other thing that I didn't anticipate, if we're going to hold the accountability crystal ball session, is that the rule on LDTs by the court and that they were not regulated as medical devices has led to a real upsurge in interest from private equity and other investors in diagnostic companies. And I think most emblematic of that was the acquisition of Exact Sciences recently by Abbott for $21 billion. So the largest deal ever in diagnostics. And I was just at the Piper Healthcare Conference in New York. And there's this whole renewed energy around particularly advanced diagnostic companies like Natera and Guardant and others. And I think that's very much been unlocked by investors now knowing that those companies won't have their tests blocked by FDA as LDTs, right? So there's always a yin and yang, and that's the way it is.

Bobbi Pritt, M.D.  (08:32):

Yeah. It's very interesting. And really that is one of the, you know, biggest, didn't you say biggest, the biggest acquisition that we know about now, right?

William Morice II, M.D., Ph.D.  (08:42):

In diagnostics it is, yeah.

Bobbi Pritt, M.D.  (08:44):

In diagnostics.

William Morice II, M.D., Ph.D.  (08:45):

And they've actually been one of the largest in healthcare in the last three years. And you think about that as a diagnostic company, it's just, I sound like Curb Your Enthusiasm, but pretty, pretty interesting. Yep.

Bobbi Pritt, M.D.  (08:56):

Yeah, we'll have to keep an eye on that. Well, what about in Mayo Clinic Labs? What are some of the things you've reflected on for important advancements in 2025?

William Morice II, M.D., Ph.D.  (09:07):

Well, I think number one, it's that we have continued to evolve our relationship with Mayo Clinic and the Department of Lab Medicine and Pathology, both in Rochester and in Florida as well. Really think about how, as DLMP innovates in response to patient needs, we as Mayo Clinic Laboratories can provide a conduit for that to reach more and more patients in a way that's economically sustainable. Also for us, it was a really successful year. We had this transition to a platform company, meaning we're bringing other people's diagnostics to market. And we've had some real success there, particularly in the neurology space with the company C2N, which was interesting because Dr. Algeciras had developed our own immunoassay, and then C2N is mass spec-based. And the question was, are people going to be confused? Is it going to hurt one versus the other?

And what we've seen is that there's a real appetite for different types of diagnostics, even for the same disease. So both have grown side by side. So the idea that Mayo Clinic, and what you've created and I've created and Mayo Clinic has created, is something that can really help provide clarity for doctors and patients on what kind of testing they need and help others that have great tests get to market, is quite gratifying. I think it's a significant advancement. And it also validates Dr. Farrugia's Bold. Forward. vision of Mayo Clinic as a platform as a whole. So those things are all kind of cool.

Bobbi Pritt, M.D.  (10:20):

It's neat that Mayo Clinic Labs can do that. It's rather uniquely placed to be able to do that, and yet still drawing upon all the rich resources and innovation within the Department of Lab Medicine and Pathology here at Mayo. And of course, all of our rich patient care and all the clinical algorithms that we're building with our colleagues that are patient-facing.

William Morice II, M.D., Ph.D.  (10:40):

Yes. The quality of the testing is really important for what we do every day, but ultimately, as you've talked about, me too, it's the knowledge around how to use that testing to really help inform a decision that a patient or a provider or a doctor or nurse has to make. I think that's really what makes our profession what it is. And so being able to grow that with Mayo Clinic, DLMP and others, it's quite a calling. So we're going to keep going after.

Bobbi Pritt, M.D.  (11:05):

Awesome. So focus on the patient, that’s what's important.

William Morice II, M.D., Ph.D.  (11:09):

That's right.

Bobbi Pritt, M.D.  (11:10):

So it was great reflecting back with you on 2025, and so I think maybe the next time we meet we should start getting that crystal ball out again and see what you predict for 2026.

William Morice II, M.D., Ph.D.  (11:22):

All right. I'll anticipate being around and being accountable at the end of the year, too.

Bobbi Pritt, M.D.  (11:26):

That's right. All right, well thanks Bill again, and happy holidays.

William Morice II, M.D., Ph.D.  (11:30):

Happy holidays to you, Bobbi.

Bobbi Pritt, M.D.  (11:37):

Let's wrap up with the top takeaways and how to learn even more of the topics we discussed. So in our news summary, we talked about a mutated strain of influenza. We shared tips for staying safe during the holidays, and you can find additional resources and safety tips from the Mayo Clinic News Network, linked in the show notes. Then Dr. Morice and I went into the deep dive summary, and we talked about the trends and advancements that shaped our industry in 2025. And we are going to hold Dr. Morice accountable for what he predicts next time we talk on advancements in 2026. So to explore more, check out Dr. Morice’s recent article on Mayo Clinic Laboratories’ innovations and his predictions for 2025 from earlier this year. They're both linked in the show notes. Thank you for joining us today. This is our final episode for 2025. It was an exciting year for “Answers From the Lab” as we rolled out our refresh and explored everything from outbreaks and regulatory changes to new tests and innovative technologies. We look forward to continuing to learn and explore with you in the new year. Our first episode of 2026 will publish on January 8, and I hope you'll join us.