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Foreign. Sometimes we have to be careful what we ask for. All right, now let me put this in perspective. Sometimes there's innovation that changes clinical management and changes outcomes for the better, and that's what we all should seek. And innovation that improves maternal or neonatal outcomes. Specifically talking about pregnancy, right? Or high risk pregnancies. But sometimes we get tests that we get a result for and we're like, okay, I dig it. I'm with it. Now what and what happens is we're not really sure of what to do with the result because we don't have any targeted treatments for it. Now we're gonna get into this and we've covered something similar to this in the past. Back when the FDA cleared serum biomarker screening for patients already diagnosed and who are inpatients with a hypertensive disorder or preeclampsia, there was a blood test that looked at a specific ratio that you could draw and that gave a prediction of who could get into severe criteria within the next two weeks. ACOG then released a statement about that. And you know, that statement is, look, I don't know what to do with it. That was ACOG's clinical practice update on biomarker prediction of preeclampsia with severe features. And just to be clear, this was based on the Thermo Fisher test that came out like in 2023 and this practice update came out in June of 2024. Release regarding the blood test, I looked at a specific ratio. It looked at the ratio and we've covered this in the past between serum soluble FMS like tyrosine kinase 1 and placental growth factor, that was intended to represent the imbalance in angiogenic substances and biomarkers. All right, we've covered this. That's the Thermo Fisher test to look for those who are inpatient, already diagnosed with a hypertensive disorder or preeclampsia to see if. If they're gonna get severe criteria in two weeks. The problem with that is what do we do with that when it comes back positive? They're already in the hospital. They're already getting surveillance. They are already getting rate of growth ultrasounds to look for problems. Well, how does that change management? So ACOG's clinical recommendations back in 2024 regarding that test, remember those patients were already diagnosed with a problem. ACOG's clinical recommendation was that there was, quote, insufficient data to recommend management strategies after a positive or a negative test result. In other words, I don't know what to do with that. And that also was echoed in smfm, who also adopted that clinical practice update, and it's on the SMFM website as well. Okay, well, now there's a new San Francisco company that has launched a new blood test that has also been marketed, by the way, direct to consumer. Right? So patients can order this. They'll send off a lobotomist to their house between 18 and 22 weeks, draw a blood test. It goes to a CLIA certified lab. Boom, boom, boom, they get a little app, and it says, hey, you have 99% chance of not developing preeclampsia or, oh, you have a higher risk of developing preeclampsia. Okay, now the question is, what do we do with that? Is there a specific treatment to take that can prevent that patient from going down that road? And the answer is yes, we already have a test. I'm sorry, a treatment to do that, and that is aspirin. Now, if you're really worried about the patient, you can give them two baby aspirins. And we've covered that at 162 milligrams versus 81. Or you can stick with the 81 milligrams. We've talked about all of this. Now, remember, guys, we're talking about a new blood test called the Mervey Encompass test. We're going to get into it in a minute. But. But it's meant to be drawn between 18 and 22 weeks to predict who can then develop preeclampsia, and it did that. The test actually had some positive predictive value. And it showed that nine out of 10 people, women who actually had the blood test drawn and it was off, 9 out of 10 of these pregnant women went on to develop preterm preeclampsia. All right, so yes, the question is not does it work? The question is what? What do we do with that? Now, remember right now there's three strategies, three strategies on how to prevent preeclampsia. One is the risk factor based classification system from acog, which is ACOG obviously endorsed to put patients into either high risk or moderate risk or low risk category. Those with two moderate risk factors or a single high risk factor, then get aspirin. That's called risk stratification. That's, that's algorithm one. Algorithm two, or pathway two, is universal aspirin. That's my idea. Just give everybody aspirin less. There's a contraindication. And those who you are really worried about, like they have an IVF pregnancy and they are obese and they're African American and say they smoke, they need two baby aspirins. That's algorithm two, just universal. And then up the ante, up the dose. If they've got super high risk factors. And. And then the third, which is this possibility. Again, while they are now marketing to physicians offices, there's also a component of this that is direct to consumers. So I'm doing this because your patients may ask you about the Mervey Encompass test. Now, again, this is done between 18 and 22 weeks. And my issue with this, we're going to talk about it in a minute after the intro's over is you get this at 18 to 22 weeks, but the peak time to start Aspirin is when 16 weeks or under. It seems that the earlier you take it. Remember, aspirin is supposed to be taken and the current recommendation, starting after 12 weeks upwards up to 28 weeks, but the goal is to start at or under 16. So you've kind of missed this window. Okay, so what do we do with this? I mean, ideally she should have been on aspirin already. Starting aspirin at 22 weeks is fine, but you get most of the benefit in the angiogenic imbalance. You try to reset that. Most of that benefit is at or under 16 weeks. So here's the deal. When somebody says, hey, we got a new blood test that a patient can order between 18 and 22 weeks and it's going to give them a prediction of preterm preeclampsia, my first answer is,
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well, isn't that special?
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Well, isn't that special? Now, I'm not trying to be mean about it. I'm all for innovation. You all know me, I'm all for innovation. Well, isn't that special? I'm all for innovation and I think there's a place for this. I really do. However. Okay, well, I have a blood test. It can predict pre eclampsia. Well, that's great. Isn't that special? What do I do with this? Once it's positive, does this actually change neonatal and maternal outcome? We don't have that data. So I'm going to give you some of the limitations on this brand new test. Again, there is a publication I'm going to talk about briefly out of Nature Communications in 2025, but that was a validation study where patients who had preterm preeclampsia or late onset preeclampsia, they drew their blood looking at RNA signatures. I'm gonna tell you the science behind this after the intro and they said, all right, these patients have these biomarkers off that. We're gonna use those then to include that for patients as their BioMarker screen at 18 and 22 weeks. So, yeah, there is some science there. This makes biological sense, guys. This, the, the science behind Mervy Encompass is legit. It does work. The question is just like Thermo Fisher, what do I do with a test that tells me something that I don't really have a medicine to fix outside of aspirin?
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Well, isn't that special?
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So again, I'm all for innovation. And I am not. Just to be clear, I am not, you know, minimizing this. I love it. Anything that we have in our armamentarium to fight preeclampsia I think is fine. But it is yet to be seen what this means in the general population. Yes, it does work. The test can identify nine out of 10 pregnancies that will develop preterm preeclampsia. But if you're worried about them anyway, they should be on aspirin. I think I've set it up enough. We will come back and talk about Mervey's new Encompass serum blood test that also has a component of direct to consumer. We're going to talk about this when we come back. This is Dr. Chapma's obgyn no spin podcast. So good, so good, so good.
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Hey, there's a new blood test that can help predict preeclampsia. Well, isn't that special? All right. I couldn't resist. All right, Michael, stop. Stop it. Stop it. When you get in trouble. All right, so yeah, you can actually go to encompasstest.com not a sponsor. And patients can order this themselves. They will send out a vampire, a phlebotomist, suck some blood out, send that to the lab between 18 and 22 weeks. You get your results in 10 to 14 days. I'm preparing you podcast family. If your patient comes into you with their app and it says, I am at high risk, and they're 22 weeks already, your answer is, honey, you missed that boat. That should have been 16 weeks or under to start aspirin, but I guess we'll do it now. And since there's no specific targeted treatment yet to do something with this result. We're just gonna have to see how it goes. So this is the issue here. Now, I'm all for finding better ways than risk stratification. As you all know. I don't like that. I don't do that. I offer universal aspirin. I think aspirin should be in prenatal vitamins. As long as you don't have, you know, some kind of gastritis or bleeding ulcer or aspirin induced airway, you know, reactivity or something. Aspirin is legit. It works. I think everybody should get it. And there you go, you fix the problem right off the bat with a baseline of 81 milligrams and then again, kick it up a notch to 162 milligrams, take two of them at night because nighttime dosing is better. We've covered that. Is there a better time to take aspirin? The answer is yes. It should be at night and has to do with circadian rhythms, cortisol levels, and a lot of other things. But I'm not sure what to do with this. I'm all for something else. We do know that the risk ratification is okay. That's why it's ACOG endorsed. But There was a study out of JAMA that said, yeah, it's actually pretty good, it's okay, but it can only pick up about 89 and change. So let's round it up to 90. 90% of pregnancies at increased risk of preeclampsia. That's all right. That's pretty damn good to me. If it's missing 10%. Okay. However, if we can move that up a little bit, then that's even better. The question is, then what do I do with that? Again, if somebody is positive on the risk stratification profile, they get aspirin. Well, if somebody's positive on this, they've kind of missed the best time to take aspirin, but I'm still going to give them aspirin anyway. We don't have the data as to whether true neonatal outcomes is different. Now the idea is that, you know, if you could potentially, you can do, do lifestyle modification, you know, put them into surveillance, you know, do something and it comes, the app comes with, you know, little ideas and strategies. But we don't have data for that. Then maybe you can keep a kid out of the nicu. But we don't have that yet. We don't have that yet. Right. But there, there is data here. I mean, again, the science behind this is legitimate and it's looking for sell free. So just to be clear, what we're doing with the child in genetic screening is cell free DNA. Now this is using cell free RNA and it uses a variety of different algorithms and biomarkers through RNA signatures and AI algorithm. Okay. To kick out this RNA profile, again, you can go back to the nature publication from 2025. They kind of looked at thousands of pregnancies, those who had early onset hypertensive disorder or late onset, and said these are the signatures that we're going to look for. And sure, yes. I mean, this has some validity here in that if it's negative, you've got like a 99% chance of not developing. So that's good. I guess. I could stop aspirin, I guess. But the issue is, is that if it's positive. Yes. Nine out of ten of those will go on to develop some kind of preeclampsia and it tended to function better in the preterm range. All right, so yes, this is good. I mean, this works. The problem is I don't have a targeted treatment to give you an injection and go there. I have now fixed this imbalance and you're going to be better. There's also something Very important here, guys. Very important here that there's a specific population that Mervey, the company, has put out as to who qualifies for this. I'm going to say this right off the bat. This isn't a lot of my patients, okay? So, I mean, I have a very high risk population. Duh. And with the patients that come in are sick and they're over 35, they've got some kind of diabetes, you know, type 1 or type 2, and they've got some form of essential hypertension. So let me just tell you who is eligible for this, okay? So they got to be 35 and above and pretty much have no medical issue. Now, let me explain this. Here are the ones that are that. This is not validated for multiple gestation. That's too bad, because that's a higher risk for hypertensive disorder, pregnancy. Those with preeclampsia in prior pregnancies. Well, damn. I mean, that's. You got the high risk right there. Again, I'm giving them 162 milligrams. Anyway, those who have type 1 or type 2 diabetes, so class B diabetes on the white scale or above, they can get this, okay? That takes out a lot of my patients. Those who have chronic hypertension, renal disease, lupus. We've got a lot of patients with lupus or antiphospholipid antibody syndrome. So, you know, if Your patient is 35 and, you know, has none of those, then they would qualify. So 35 or older at time of delivery. I want to be clear. If 35 or older at time of delivery and without things like chronic hypertension, renal disease, it can't have lupus antiphospholipid syndrome. They can't have preeclampsia in a previous pregnancy. They can't have multiple gestation, has to be a singleton, and they cannot have class B diabetes. Or further on down the letters, okay? Or chronic hypertension. So it's a very niche deal, right? Again, I'm not trying to poopoo this, guys. I'm really not. I just don't know. I don't know what to do with this. When Thermo Fisher came out and I saw all that data, I was like, okay, okay, maybe I can get with this. And then we started. You know, all the reports started coming in and the commentaries, which I agree, somebody asked for a comment on that, and who knows? I forgot where that came out. Anyway, I said the same thing. I don't know how this changes anything except maybe give the patient more anxiety. So while this is innovative. I think the use of cell free RNA as a direct to consumer or physician offered test. You gotta know what you're getting and the limitations here. And first of all, we need definite real world, multi site population based studies that these things work. And right now ACOG says these biomarkers for preeclampsia hypertensive disorders. I don't know what to do with this. Give them aspirin. That's the best that we got right now. And until we have a true biomarker equilibration tool to fix the ratio, I don't know what to do with this. So the clinical actionability. Yes, that is actually a word. The actionability of a study is kind of uncertain. It's kind of in the same camp here, guys, as Thermo Fishers. Plus you got to send it to that one lab, it's got its proprietary and its algorithm. I don't know, is this going to take off and it's going to revolutionize preeclampsia management? No way. Because it's 35 or older at time of delivery without those issues. And we're missing a big chunk here of our pregnancy population, especially our teenage patients, which I've got a vast, vast percentage of mine are in the teenage years. So I'm gonna give them aspirin anyway. So these are just some of the issues here. I just want to let you know I'm not against this. I just, I'm definitely not gonna be an adopter of this right now until we have more data. So I'm just. And the reason we're doing this is because somebody asked me to opine on this. Got a buddy in Austin who said, hey, what do you think about this? I'm like, bro, I'm not feeling it right now. I'm not feeling it. And I don't like them going direct to consumer because it's going to put physicians in a bind. If you haven't heard about it, you're like, I don't know what this is, some weird app, what some strategy, what is this about? And that's why I'm doing this right now. So that you know, so you're not blindsided. Because it's out there. All right? It's out there. So anyway, it is what it is. The Mervey Encompass blood test for preeclampsia prediction. Fine, let's see what happens. I suspect that there will be another statement that would come out like, hey, you know best what we can do is risk stratified. Best that we can do is give them aspirin. If you're really worried about them, up the dose. And that's about it for right now. There are some clinical actionability issues on this, but, you know, we just want to let you know what's out there. The latest publication from this was 2025 in Nature Communications, which again, looked at early in late preeclampsia and looked at their RNA signatures. But we definitely need real world data. Podcast family, I think I have done what I'm supposed to do. I think we have worn out the church lady from snl Isn't that special? Michael, before we get into trouble, let's just shut this down, all right? Podcast family, we're thankful for you. We'll see you on the next episode of the Ob GYN no Spin Podcast. Michael, let's take it home. This is Dr. Chapa's obgyn no spin podcast.