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. I'm excited to be here today to be joined by Mayo Clinic Laboratories CEO and president, Dr. Bill Morice. We're going to talk about the latest news, and then I will be speaking with Dr. Matt Binnicker about seasonal viruses during our deep dive. Bill, welcome back.

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

Yeah, great to be back.

Bobbi Pritt, M.D. (00:29):

So, we have a number of things we could talk about today. Let's talk about something that is quite interesting. Mayo Clinic and Thermo Fisher recently announced a partnership and an LLC called Precure. It's a new company based on building one of the world's largest biomedical datasets to help identify biological signals of disease, ideally long before symptoms appear. So, this would support personalized treatments. You're familiar with this. What does an initiative like this reveal about the value of laboratory medicine?

William Morice II, M.D., Ph.D. (01:02):

Precure is very much a discovery effort that reflects both the expertise and the clinical delivery and longitudinal care delivered by Mayo Clinic, and then some of the really cutting edge biomedical and biological sciences capabilities of Thermo Fisher coming together. In this case, to look at not just genomics, which have been the first bastion I think of personalized medicine, if you will, and using in-depth genomics to evaluate patients and individuals, to now look at other biomarkers essentially in the peripheral blood, including proteomics and even metabolomics, I think in some instance in a large number of individuals. Because of Mayo Clinic and our presence in our community, and our longitudinal relationship with our patients, we have specimens that well predate their actual appearance of disease. So, the concept of Precures is, can we look back essentially and start to see signals before symptoms appeared of different conditions that we could detect in the peripheral blood?

And then from there, of course, the idea would be to develop both diagnostics that in a clinical laboratory, not in a research setting, could actually validate those as clinical analytes, and then at the same time, develop therapeutics.

Bobbi Pritt, M.D. (02:16):

Yeah, it has a lot of potential. It's very exciting. And I think we're also now thinking about, as you said, not just genomics, but proteomics, and some of these partnerships I think are going to be very important.

William Morice II, M.D., Ph.D. (02:28):

Yeah. It's an interesting concept, right? On the one hand, it's kind of like, some of it's been around for a long time. So, there are a lot of studies, for those that are interested in population health and other things, there’s a lot of studies out of Olmsted County, and that's because of the Olmsted County Medical Registry, which we've had for literally decades and it's actually a partnership with the county. So, we've been able to go back and look using existing tools, but now have the ability to drive insights. And those insights will come from a place like a Mayo Clinic or a healthcare organization that has a really deep history in its community and in serving patients. And now, partnering with companies like a Thermo Fisher that has Olink and has technologies that can really provide insights into things that we just never had the capability to do before.

And the partnership has multiple facets and multiple benefits. One is that it brings the technology in contact with the clinical practice and the specimens and the Mayo researchers and others who will benefit from that and creating an open system through the LLC that others can interact with it. Then of course, the other is just that building out those diagnostics and making them scalable so they can impact positively as many patients as possible. I think collaboration, as we've talked about many times, is the way of the future here. Luckily, with Thermo in particular, we've had a history, and that's the other thing, you know, collaboration is building trust in a relationship like anyone else or any other entities. Going back to my time as department chair, we had really worked closely with Thermo Fisher in our Advanced Diagnostics Laboratory, as you recall, to kind of do some of this work at the more clinical end. So this is really an extension. It's kind of gratifying to know that our department was a big part of helping to build out that relationship, which can culminate with a big partnership like this.

Bobbi Pritt, M.D. (04:12):

Yeah, it really shows the importance of DLMP, but also lab medicine as a whole and what we can contribute. And I love the concept of Precure. Well, let's move on to another topic because this is a big one as well. CMS just released their 2027 PAMA preliminary rates, and this is the fee schedule. And of course, this is a result of the PAMA legislation that we've talked about in numerous past episodes. Can you give us a little bit of an overview on this topic and what the changes are?

William Morice II, M.D., Ph.D. (04:43):

Unfortunately, they're not changes. Just to remind people, the Protection to Access to Medicare Act, or PAMA, was passed well pre-COVID, and so several years before COVID. It was really designed to have market-based pricing for laboratory tests, meaning that we would get market data, the government would get that market data, CMS, and they would use that to determine rates for laboratory testing. Well, pre-COVID, we saw when the law was implemented, it's just very difficult for many labs to report this information. That's how the law was written, that the labs themselves have to report. And so, we get under-sampling, if you will, of the overall laboratory market, which sends a skew of the prices lower than they really are. This was raised before COVID. During COVID, there was a recognition of this by the administration, and that's why there were the delays.

So, that's why this feels new. We haven't had this in place for several years because the proverbial can was getting kicked down the road. But as of last year, they did not have another delay, so that kicked off the whole data collection process, which we talked about over the summer. The data's back, and CMS has published the results of that. Unfortunately, disappointingly, but not surprisingly, it's again, a minority of labs that have reported, particularly a minority of hospital laboratories. And so the data is, again, a bit skewed to the lower end of the reimbursement spectrum, which is a problem because now that means that CMS can cut the amount that they pay for those tests, and it's a significant number, I think over a thousand, a maximum of 15% this year. And so, many tests will actually hit that floor of 15% reduction.

Bobbi Pritt, M.D. (06:22):

Yeah, I have the actual numbers here. The rates will be reduced for 1,170 tests, and that includes 775 that would face that maximum 15% cut in 2027. And then those tests will be set up for additional reductions in 2028 and 2029.

William Morice II, M.D., Ph.D. (06:40):

Yeah. So, I mean, it's a big, big deal. It's a big deal for laboratories. It's a big deal for our patients. It will affect labs. We'll have to make choices about what tests they continue to run, which then affects access and all those sorts of things. I think the good news, if there is a silver lining on this, there's two things. First, we have the opportunity to comment to CMS. And labs, I know professional organizations, I'm sure CAP, ACLA, which I'm part of, American Clinical Lab Association, will all put public comments in, which is great. But the good news is there is a bill that's been introduced, the RESULTS Act, which would change the data collection from labs having to report not just hospital labs, but to an actual third party so the data is more complete.

Actually, would delay implementation of cuts for a couple years as we got the right data in the system to understand what the market was really doing. That has very significant bipartisan support. I think over 140 co-sponsors have signed onto that bill. So, Congress recognizes there's a problem here. So again, it's a really important time for us to have our voices heard as laboratorians. And, ACLA has this website, Stop Lab Cuts Now. There's others that are out there where you can actually find out your Congressional representation, has a form letter you can send to them. So, that will really make a difference because we're going to now have to hope that legislation will get enough attention to be passed, probably as part of end-of-year legislation, which also means we're going to be living with uncertainty about whether it will pass, probably into December.

Bobbi Pritt, M.D. (08:07):

Yeah. We're going to be talking about this probably for a little while as we wait to hear. Multiple organizations are working very hard on this right now.

William Morice II, M.D., Ph.D. (08:14):

Yeah, totally agree.

Bobbi Pritt, M.D. (08:15):

Well, thanks for touching on these two very important issues, Bill. We'll keep talking about these. Thanks again for joining us.

William Morice II, M.D., Ph.D. (08:22):

Happy to do it every time.

Bobbi Pritt, M.D. (08:23):

Wonderful. Welcome to the deep dive. We're going beyond the headlines today with Dr. Matt Binnicker, Mayo Clinic Laboratories chief scientific officer. He's also a leader in developing novel diagnostics to aid in detecting viral infections. And today, he is here to discuss with us viral activity and detection. So Matt, welcome back. It's always so good to have you with us.

Matt Binnicker, Ph.D. (08:51):

Hey, Bobbi. It's great to be back. Thanks for the invitation.

Bobbi Pritt, M.D. (08:54):

Of course. And, you know, this is such a good time because now that fall is here, I hate to say it, but fall is here, and there's an increased interest in seasonal viruses, influenza, COVID, et cetera. So maybe you could just start with an overview of, what are some of these common viruses that we see this time of year?

Matt Binnicker, Ph.D. (09:14):

Yeah. There's really the big three that we think about most prominently, usually from October to March each year. And those are influenza, respiratory syncytial virus, or RSV, and then since the pandemic, COVID-19. There are a few others that can cause problems during the winter months, human metapneumovirus being one, parainfluenza viruses, but really it's those three, influenza, RSV, and COVID-19 that we worry about the most and that seem to be most prevalent during the fall and winter months.

Bobbi Pritt, M.D. (09:47):

Yeah. Is there any reason why the viruses tend to be prevalent this time of year?

Matt Binnicker, Ph.D. (09:51):

You know, that's such a fascinating area, and there's a multitude of reasons. And many people think, well, it's cold outside. A lot of people spend time indoors and so they're around other people. That may play some role, but there's a number of factors, both host and environment, that cause increases in prevalence of these viruses. From the host side, because it's colder and drier in terms of the humidity levels, our antibody levels in our upper respiratory tract actually don't function as well, and the cilia on the cells in our nasal passage don't function as well as they do during the summer months. And so, we're not able to clear foreign pathogens and foreign objects as well. So, there's that host factor. But then from an environmental perspective, I mentioned humidity, and that's actually a huge contributor to spread of respiratory viruses. When the humidity is lower, as it is in the winter months, any droplets that we produce when we talk, cough, sneeze, are smaller in size and they're suspended for longer periods of time and further from us. And that promotes transmission of these respiratory viruses, versus in the warmer months when the humidity is higher, those droplets are larger, and they fall to the ground or floor faster. And they've actually shown that just by putting a humidifier in school classrooms, they can lower transmission of respiratory viruses. So, a number of very interesting factors all come to play.

Bobbi Pritt, M.D. (11:29):

You know, that really is fascinating. And I've heard with air travel, it tends to be quite dry. And so there's that concern about viral infections passing amongst passengers. Yeah, interesting. Well, that's really good to know. So we know it's not quite here yet, but coming up, we should all be thinking about these viruses. Do we have any predictions for what we might see this coming year? I know they like to try to predict, but I realize the crystal ball isn't always clear.

Matt Binnicker, Ph.D. (11:58):

Yeah. We can get some intelligence from what happens in the Southern Hemisphere, because as you know, the seasons are flip-flopped. And during our summer months here in the U.S., it‘s the winter months in the Southern Hemisphere, like in Australia. And so, our Centers for Disease Control and other health agencies are monitoring what's happening in countries like Australia. And Australia has experienced, I would say, a more typical influenza season. 2025 was actually a record-breaking, a severe influenza season in Australia, and it's been not to that level this year, which is good news. They're actually seeing kind of a late-season surge, so I think it remains to be seen exactly how the flu season in Australia turns out. But so far, the numbers are much less impressive in terms of sheer magnitude of influenza in Australia as we saw in 2025. So I think that's a hopeful sign, but as you pointed out, difficult to exactly determine what's going to happen here in the U.S. I know that the CDC is planning to come out with their 2026-2027 forecast for what this season may hold for us in the coming weeks. So, we should know more soon.

Bobbi Pritt, M.D. (13:17):

Well, that's good to hear. And maybe reassuring what we know about the season, for example, in the Southern Hemisphere. And of course, we do have vaccines, and Dr. Morice and I just talked about that. So, it's a good time to start talking to your healthcare provider about what's right for you. And then of course, should someone fall ill, we know testing is so important for monitoring and managing viral infections, but of course, it's not always appropriate to test everyone with symptoms. Can you tell us what guidance you have in, when we should test for seasonal viruses, what patients should know if they're not starting to feel well?

Matt Binnicker, Ph.D. (13:52):

Yeah. So, I would say that the majority of individuals who come down with a respiratory illness in the coming months, if their symptoms are mild to moderate, and by that I mean you've got a scratchy throat, you've got a cough, runny nose, maybe you just don't feel great, you probably don't need to go in and get tested. You likely are going to have a seven- to 10-day illness. You should stay home if possible. If you go out into a public setting like a grocery store or you have to go to work, I think it's still a great idea to consider wearing a mask in those situations, but probably don't require testing. But if you start to develop a fever, if you feel like you can't get off the couch, if your illness is kind of progressing from the moderate to kind of severe category, or you have an underlying health condition, let's say you're on an immunosuppressive drug, you're an elderly individual over the age of 65, or you live with someone who has an underlying health condition, for example, a spouse, a parent who is taking chemotherapy for cancer, then it's probably a good idea to go in and get tested for influenza, RSV, COVID, so you know what you're dealing with, nd so that your physician can consider treatment options for you or your family members, who may be living with you, in the event that you're positive for one of those viruses.

Bobbi Pritt, M.D. (15:26):

Yeah, that makes sense. And it's nice that we have some treatment options for some of these viruses now. And then of course, it's nice to know maybe preventative measures, if you know someone has influenza, then what they should do to avoid spreading that to other people. So, good to know. Now, this is what we have for diagnostics now. What do you think is in the pipeline? Are there any new innovations besides the standard things that we talk about, things that you might be excited about for respiratory virus detection?

Matt Binnicker, Ph.D. (15:56):

Yeah, the current tools that we have that you touched on, antigen tests are an option. You can go to your Walgreens store, local pharmacy and pick one up. I think those are good options for screening at home. PCR tests that usually combine influenza, RSV, COVID-19 if you need to go in and see a physician, and even some rapid point-of-care tests if you go to an urgent care clinic. But coming down the pipeline, there's some really exciting technologies and innovations that I think will impact how patients are tested in the future. I think things will move closer and closer to the patient, meaning you may be able to collect a sample at home and have it sent in to the laboratory. There are going to be more options where you're actually going to be able to collect a sample and get a lab-quality test performed at home more frequently in the future, more commonly.

There are also some technologies that probably won't be needed for kind of common respiratory illnesses, but maybe in more severe cases where someone might require to be seen by a physician or especially hospitalized, that's called metagenomic sequencing. I think in the future, a patient may have a swab collected from their nasal passage or their nasopharynx, and there can be a sequencing assay performed that doesn't need to be defined to two or three viruses. It's going to look for any virus that's present or other pathogen. And that may become more common. Now, probably not in the next year or two, but five to 10 years down the line, I think that that's something that we'll see. And then artificial intelligence is definitely going to impact diagnostics as well. And there's been several publications where research groups have used patient information, their symptoms that they're experiencing, and then even a photo, for example, of their throat. And the image of the patient's throat and the redness and the inflammation, along with their age and their temperature and other symptoms, and it will actually give a score of how likely you are to have one infectious agent versus another. And so, that's just kind of a proof of concept, but I think we'll definitely start to see more application of artificial intelligence, at least screening, helping to guide patients and physicians on what testing or therapies they may need.

Bobbi Pritt, M.D. (18:28):

Oh, that is very exciting, Matt. And, I see these technologies coming into the lab. They're getting cheaper and faster, more reliable. I agree. I think we're going to see metagenomics, AI just become part of routine testing.

Matt Binnicker, Ph.D. (18:40):

Totally agree.

Bobbi Pritt, M.D. (18:42):

Well, this has been a great discussion, and I think, again, good timing since we're starting to come into respiratory virus season. So, it's probably a good idea to remind everyone to talk to their physician, talk to their healthcare provider, start thinking about vaccination for some of these very important diseases. And I think you gave a really nice discussion about what some of those viruses are and how they're detected.

Matt Binnicker, Ph.D. (19:04):

Yeah. Well, thanks again for the invite. Always a great topic to discuss. And if I want to leave the audience with one thing, it's to go in and get your annual flu and COVID vaccine. And there are also options now for RSV if you fall into certain age categories.

Bobbi Pritt, M.D. (19:18):

Right. Certain risk groups. Great discussion again. Well, thanks, Matt, and I'm sure we'll have future discussions.

Matt Binnicker, Ph.D. (19:25):

Thanks, Bobbi.

Bobbi Pritt, M.D. (19:31):

Let's wrap up with the top takeaways and how to learn even more on the topics we discussed. In today's news segment, Dr. Morice and I discussed a new collaboration between Mayo Clinic and Thermo Fisher Scientific focused on identifying disease earlier, before symptoms appear. You can learn more about that initiative through a link in the show notes. We also talked about our latest PAMA developments, and we encourage you to stay engaged with your professional organizations as many prepare advocacy efforts around long-term legislative changes. We've included links to the preliminary CMS fee schedule and additional background resources in the show notes if you'd like to explore this important issue further. After that, Dr. Binnicker joined us, and we had an update on seasonal viruses, including what to expect this winter and some testing guidance. We've included resources in the show notes about testing for respiratory viruses that we discussed today.

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. Eric Hsi and I will talk about innovation in laboratory medicine. I hope you can join us.