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

Hello, I'm 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 some trending topics. Then, Dr. Janelle Santos will join me for a deep dive and we'll discuss a diagnostic tool for preeclampsia that she's using to care for patients. So, let's start with you, Bill. Welcome back.

William Morice II, M.D., Ph.D. (00:26):

Thanks, Bobbi. I think you have to put in your tagline an accomplished podcaster as well, but there you go. But yeah, it's great to be back as always.

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

Yeah, and you've been doing a lot with ACLA recently, and of course you serve in that leadership role. And I know you have some things to share with us on that.

William Morice II, M.D., Ph.D. (00:43):

So yeah, just for the audience as a reminder, ACLA is the American Clinical Laboratory Association. So, it's the trade association for clinical laboratories in Washington, D.C. I have served as the chair of the board for the last few years. I just got elected to a second term here about a year ago.

Bobbi Pritt, M.D. (01:00):

Oh, congratulations.

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

Thank you. Yeah, it's quite an honor. I mean, a lot of the industry leaders there, from Exact Sciences and Natera to Quest and LabCorp and Myriad. So a lot around that board table, and a lot of labs participate. So it's a real honor. It's a real way to learn about what's happening in our industry and also has really opened my eyes to something we've talked about a lot on this podcast and that is this intersection between what's happening in public policy and its impact on us, on our daily lives in the labs. Right? And so, I think we're kind of removed from it. So, we may not think about it all of the time, but it's certainly there. And so the annual meeting that they have is a great one to attend if you're interested in that. And certainly, it's always a great learning experience for me when I'm there.

Bobbi Pritt, M.D. (01:40):

Yeah, I know you talk a lot about government affairs there, and of course, ACLA is really big with advocacy, advocating for our laboratories, state and federal issues. Do you want to give us an update on what's going on there?

William Morice II, M.D., Ph.D. (01:52):

Yeah, I can. I'll give you the sweeping landscape, because I could go on and on.

Bobbi Pritt, M.D. (01:58):

You could go on and on for that one.

William Morice II, M.D., Ph.D. (01:59):

Exactly. I think probably most pertinent, if there was like a couple of headlines for the labs, number one is I think a shift from the focus on FDA, when we were worried about the final rule of oversight of LDTs, and that was really the focus in 2025, really more to a focus of CMS as the agency within Health and Human Services that we'll be thinking about. CMS just put out an RFI around decreasing fraud and abuse in healthcare. I think that agency, under Dr. Oz, will be probably quite active this year. There have been some leadership changes in HHS as well, with Assistant Secretary O'Neill stepping aside, and there's new leadership in. So, that I think has more CMS-type experience. So, I think that's one of the trends that we'll see, which will be focused probably more on reimbursement.

Of course, we have PAMA, where labs will need to report their data here coming up, so that the new fee schedule can be set. So, I think that'll be sort of the main focus for us in the labs for 2026 will be a lot around reimbursement and CMS. The other thing that's really playing out, which is interesting and I'm seeing it really actually in the realm of AI, another thing you and I have talked a lot about, is actually a tension between state rights and particularly federal priorities coming out of the administration. And that is, the administration under Trump has been very vocal that we were going to be leaders globally in AI applications. Of course healthcare is a big part of that as we've talked about. And yet at the state level, I think where citizenry are concerned about some of the issues with AI around safety, there are laws being introduced, under the broad label frontier laws, which are trying to put in safeguards for individuals in terms of the use of AI.

And that's again, particularly applicable to healthcare because it's a lot about privacy, governance of data, who has primacy in that as the individual, those sorts of things. And so, this is something I think we'll see play out and will probably have an impact on the ability for AI tools to be introduced into healthcare, is sort of this dynamic between the push from the White House to say we should be leaders in this, and then some of the states, which are saying, "Whoa, we've got to make sure we do this safely." And that's a tension that I hadn't really appreciated until I was there in D.C. for the ACLA meeting.

Bobbi Pritt, M.D. (04:11):

It will get people talking about this, what is the appropriate level of safeguards that we have when we introduce these powerful new tools like AI, large language models, agentic models, in addition to all of the positives that they can provide.

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

Exactly right. Like anything, it's going to be a balance. And of course, as you and I've talked about, healthcare is a very high-trust environment. And so, any kind of misstep from one of these, that could be a real setback for an individual and also for healthcare. So, getting that balance right is going to be super important.

Bobbi Pritt, M.D. (04:42):

I completely agree. Well, those are great updates, Bill. And there was another topic I wanted to bring up with you because I think it really impacts what we do here in our Department of Lab Medicine and Pathology, but then how we provide our tests across the country, across the world. We had a great test development year last year, and some exciting new news. It was such a big year in 2025. We implemented, not just developed, but actually implemented a record number of new tests, 101 new tests. And in addition to that, we developed 78 more. And this is great because these are the innovative tests that may not be available elsewhere that could be provided for our own practice here at Mayo, as well as patients around the world. And as part of this, the team reduced the time it takes to develop tests, the median length, by 45.5%. So, we're now about an average of 31.7 weeks for test development to implementation for the development piece. That's important because of course we have very high levels of safety and quality that need to be adhered to, but at the same time, we want to get these tests out. So, how do you do that in a safe and efficient manner? And actually using a number of different tools, the teams have accomplished that. So I thought maybe you could kind of tell us, what do you think about that from a broader market standpoint?

William Morice II, M.D., Ph.D. (06:09):

Well, I have a couple of thoughts. I mean, first of all, for us at Mayo Clinic Laboratories, of course that's what people look to us is to A, that our departments continuing to create the new tests that are needed for patient care, and also the knowledge that you can trust them, that there's high quality, that they're really serving a useful purpose. Right? And then also that there's a knowledge, not just that you can do the test, but you can talk to someone about, like Dr. Pritt or Dr. Morice or someone else, about what does it mean for your patient, right? And so, I think we do all of those things really well. On a personal level, and actually something we can maybe talk about in a future podcast, it's quite gratifying. Because as you recall, during my tenure as department chair, is when we first started to institute some of the things that try to systematize our test development at the department level. That shows, I think, that this is a long game.

A culture change is a long game, but it really benefits everybody involved eventually. Right? And so to get there, it's really gratifying for me to see the department continuing on that trajectory. And I'll leave you with, it's not just getting the test out, but also the discovery. So at our sales meeting, which we talked about last time, the patient story was someone with a disease called rippling muscle disease. The test for that disease was developed through the investments made in the Advanced Diagnostics Lab early days, back when I was department chair as well. If you think systemically around innovation, you can not only make the discoveries, but you can bring them to the bedside much more quickly. And that just benefits everybody. I'm so gratified to hear it and happy to discuss it. I've been doing, actually just did, a white paper I think on innovation and kind of how to systematize innovation. So anyways, future topic perhaps.

Bobbi Pritt, M.D. (07:41):

Yeah, I love that. That would be a great future topic and being able to measure it. You can't monitor something if you can't measure it. And so it's important to be able to have these metrics and visibility so you know that you're innovating and then actually bringing these great ideas into the clinical practice.

William Morice II, M.D., Ph.D. (07:56):

Always great to end a podcast on a Peter Drucker quote, "You can't manage what you can't measure."

Bobbi Pritt, M.D. (08:01):

There you go. That's it. Well, thanks again, Bill. It was great having you on.

William Morice II, M.D., Ph.D. (08:06):

Great to be here, as always.

Bobbi Pritt, M.D. (08:13):

Welcome to today's deep dive. We're going to go beyond the headlines with Dr. Janelle Santos, a physician in obstetrics and gynecology at Mayo Clinic. Together, we'll discuss how she uses diagnostics in her practice, specifically how she uses a preeclampsia test from Mayo Clinic Laboratories to care for her patients. Thank you so much for joining me, Dr. Santos.

Janelle Santos, M.D. (08:35):

Yeah, thank you so much for having me.

Bobbi Pritt, M.D. (08:37):

I'm really thrilled to have a patient-facing colleague on the podcast today. I rarely see patients these days. And you're right on the front lines. So I wanted to start talking about this preeclampsia test. You know, it's something that, you know, we develop a test in the laboratory, but it's really nice seeing how our patient-facing colleagues are using it. And I understand that this preeclampsia test, you've been using in your practice. Can you walk us through a little bit about how the test works and how you use it to guide your decision-making?

Janelle Santos, M.D. (09:07):

Yeah, definitely. So, what's really unique about this test is, it's really the first test that is specific to preeclampsia within our preeclampsia diagnostic tools. And so, it's a biomarker test. It tests biomarkers that come specifically from the placenta, and biomarkers that we know go awry within the pathophysiology of preeclampsia. So when we have an abnormal result, that really tells us that there's something wrong with the pregnancy itself. Traditionally, we have measured blood pressure and other labs that can be abnormal in a host of other conditions that are not specific to preeclampsia at all. So that's very unique.

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

Well, that's great. So there's a few benefits it sounds like from this. What potential do you see for a test like this then in improving patient care? I know you sort of touched on this already.

Janelle Santos, M.D. (09:58):

We need something like this more than ever because our obstetric population is aging and becoming more sick. And so, there are a lot of things that can mimic preeclampsia, mostly chronic hypertension. And so, we're seeing a lot more of our patients enter a pregnancy with chronic hypertension or other diseases that can look a lot like preeclampsia, and then it becomes difficult for us to differentiate between the two. And so having a specific test like this is very helpful.

Bobbi Pritt, M.D. (10:25):

And, you know, our listeners love cases, so can you give us an example, like a generic case of maybe how you would handle like a negative result or a straightforward case where you were able to manage in an outpatient setting while still postponing delivery until a baby was more developed?

Janelle Santos, M.D. (10:43):

Yes, absolutely. So, we had a case somewhat recently. This patient who had, to her knowledge, no pre-existing hypertension, she was admitted at 12 weeks. So very early on, with a hypertensive urgency picture, severe range blood pressures were also above 160 systolics, above 110 diastolics, so high for pregnancy, and we had to start her on antihypertensives. We got to a point fairly quickly when she was 24 weeks that she was maxed out on two separate agents, on labetalol and nifedipine, which traditionally in our practice, you know, those are the two most commonly used medications for hypertension in pregnancy. Once patients are maxed out on those agents, we're typically heading towards delivery. But in her case, 24 weeks is still very early and would be, you know, carry a lot of morbidity for her baby. And so this was a case where the sFlt ratio really helped us. It was low, and so, we were able to say with more confidence, "OK, this is very likely a chronic hypertension picture." And we were able to keep her pregnant until 34 weeks.

Bobbi Pritt, M.D. (11:50):

Oh wow.

Janelle Santos, M.D. (11:51):

She ultimately got up to four antihypertensive agents. We knew she had a component of chronic hypertension, but then differentiating, OK, at what point has she crossed the line into preeclampsia? It was very difficult. And so this test was really useful in that case.

Bobbi Pritt, M.D. (12:07):

Oh, that's wonderful. I remember from my training a long time ago when I did obstetrics training in medical school that it's so important keeping the baby in mom as long as possible just for outcomes. And I don't know if you can talk about like, what is the difference between 24 weeks and 34 weeks mean?

Janelle Santos, M.D. (12:24):

Oh, I mean, huge.

Bobbi Pritt, M.D. (12:26):

Huge, right?

Janelle Santos, M.D. (12:27):

Yeah. I mean, a 34-weeker's survival is pretty much guaranteed. We expect those babies to do well. They are admitted to the NICU, but for some pretty short-term issues, so like issues coordinating feeding, hypothermia, jaundice. They're short stays and they're short-term issues, but 24-weekers survival certainly isn't a guarantee and there is a lot of morbidity associated with 24 weeks. I mean, some do well of course, but I think because of this test we're able to really guarantee a good outcome for this baby.

Bobbi Pritt, M.D. (13:00):

Yeah, that's so wonderful to hear. Now, that might be maybe, I don't know if that was straightforward, but it was a great simple discussion of how you described it. Does it help in more complex situations as well?

Janelle Santos, M.D. (13:13):

Yes, it does help in more complex situations. We've had patients, for example, like lupus is a situation that can be more complex. So with lupus, often patients not only have chronic hypertension, but can have underlying renal disease and proteinuria and other symptoms, fetal growth restriction, all of these things can really start to look like preeclampsia. And so, a low ratio, if everything else seems stable, can help us prolong a pregnancy. And sometimes, you know, not to say that the ratio is the end-all be-all, we have to take, you know, the entire picture before we make a decision. But it certainly is a valuable piece of the puzzle.

Bobbi Pritt, M.D. (13:55):

Well, this is really interesting, I think, I'm glad that what we do in the laboratory allows us to give real tools to people like you that are seeing our patients. So, Dr. Santos, you mentioned that not all of your colleagues are using this test yet. When you speak with them, do you have any talking points about how this test is useful in your practice and why they may want to consider using it for theirs?

Janelle Santos, M.D. (14:19):

Yes. Really, the biggest evidence that we have for this is the process trial. So, that was published in the New England Journal of Medicine. It's been, it was 2022, so been a few years now. But really it shows a very high negative predicted value for the test. So that's, that's the main value. Ninety-six percent was the negative predicted value. So, if you get a low result, it will help you triage a patient away from interventions. But the positive predictive value is pretty high, too. And it's a large cohort of patients, over a thousand patients that they had. So, that's the main study that I would point them towards if they wanted to learn more about this test, and was the main push for the FDA approval.

Bobbi Pritt, M.D. (14:59):

I do have one last question for you. What do you think about how care would look if you didn't have this test?

Janelle Santos, M.D. (15:06):

I think we would have a lot more unnecessary, early, preterm deliveries. And this test has been FDA approved. We know that it predicts preeclampsia diagnosis. We're still collecting data on how to use this test in real-world settings. I think as we become more and more comfortable, we're going to become more able to prolong pregnancies based off of the results of this test. You know, we still have to convince a lot of our clinical colleagues and collect more data on this. I do think it's going to lead to better outcomes for babies ultimately. And then also, you know, for moms too. Sometimes on the flip side, we've talked about negative results, but we do put stock in the positive results as well. So the opposite can happen, where we have very high results, and it becomes obvious that we have a very sick placenta. We say, "OK, we can't ignore this. We need to go to delivery."

Bobbi Pritt, M.D. (16:00):

Well, it's very helpful. Well, thank you again, Dr. Santos, for joining us today. It's really fascinating. I learned a lot from this discussion. Really appreciate you spending time with us.

Janelle Santos, M.D. (16:10):

Of course, yeah. Thank you.

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

Okay, let's wrap up with the top takeaways and how to learn even more on the topics we discussed. In our news segment, Dr. Bill Morice shared some takeaways from the recent ACLA board meeting. We also discussed Mayo Clinic's Department of Laboratory Medicine and Pathology's unprecedented year for test development, and how Mayo Clinic Laboratories helps then bring those innovations to people around the world. And Dr. Morice actually wrote an article recently on how to fuel this type of innovation that I thought listeners might find interesting. So you can find the link to that in the show notes. Then we went onto the deep dive. Dr. Janelle Santos joined us to share how she's using a test for preeclampsia to manage patients in her practice. We've included some links to more information about the test in the show notes. You can also search for it by its Mayo Test ID, P-E-R-A, at mayocliniclabs.com. 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. Chris Garcia will be back to share his thoughts on digital innovation. I hope you'll join us.