We'll do it like that. So, Sera is a 17-year-old company that originated in Utah, and its first activity was mapping proteins in pregnancy. We discovered over 300 proteins that emerge throughout pregnancy and give us an opportunity to spot potential adverse health outcomes, both for the mom and the baby, looking at their quantity ratios at various points in the pregnancy.
So, looking at that fantastic data set, we decided to zero in on our first product, which is called PreTRM. PreTRM test is a blood test, biomarker blood test, for the blood drawn between weeks 18 and 21 in pregnancy. It's a finger prick test, easily accessible. You can get it online, you can get it in a physician's office. And being whole blood ambient shipment, we really do. Indeed, in Salt Lake City, Utah.
So, the blood gets drawn, it gets shipped to our central lab, we'll get results to the physician within five days. And the result of the test shows if a pregnant mom is at higher risk for preterm birth. So, that's the report that the physician and mom get if you're at higher risk for preterm birth or not higher risk. We set the threshold, it's a great question. We made it as simple as higher risk or not. And we set the threshold exactly at two times the average risk. So, one out of ten babies in the United States is born preterm, defined as before 37 weeks of gestation. And when we talk to OBGYNs, every day counts. And.
I have a mistake.
Don't worry, we're good. Plug right in, plug right in. I'm giving an overview of our products and Sera history.
Okay.
Yeah, yeah. So, the results of the test highlight this higher risk for preterm birth, and it tells physicians if the mom is at higher risk for preterm birth, that there's an opportunity for action, and we tested in our clinical studies with the community a bundle of very simple interventions: three, aspirin, low-dose aspirin, vaginal progesterone, both administered daily, and care management, which is a fancy statement for weekly nurse call to check in with the mom to achieve fantastic clinical outcomes.
Specifically, we published and got the front cover of the Diagnostics journal in July of this year, our study called AVERT, which was done in ChristianaCare. It's a large study, roughly 1,500 patients compared to a historical 10,000 control that highlighted that the health of the baby was significantly better.
It was an 18% reduction in a composite score of various things that go wrong for the baby when the baby is born earlier. Of course, if the baby is born before 28 weeks, it's very different than the baby that is born at 35 weeks. Both are premature, but a 24-weeker is really, really not ready for life outside the womb versus a 35-weeker.
Extension of gestation by knowing sooner that mom is at risk for preterm birth and taking more care with aspirin, progesterone, and these weekly nurse calls make a big difference by extending gestation for as long as possible and then making sure that the baby who is born later is healthier and gets out of the hospital sooner. Those were the three or four endpoints we tested in the AVERT trial.
Number one of them, which is health of the baby, measured by this composite score that includes a multitude of challenging impacts of preterm birth, like respiratory distress, various infections, was reduced by 18%, which is a great clinical outcome. We also saw extension of gestation for those earliest born. We saw a seven-day reduction in hospital stay for babies that were under care.
Specifically for the earliest born, those before 32 weeks that I talked about that could be at risk for being impacted by the most adverse health outcomes, stayed in the hospital a whopping 28 days less than the babies who were not. It's a great question. It's a question about adoption. When we overall, OBGYNs are a conservative profession by nature. And so far, until our test, there are no good predictors of preterm birth.
There are risk factors, of course, like previous preterm birth or short cervix. The downside of those is previous preterm birth, you would need to be a second or third-time mom or fourth or fifth before you have that risk factor available to you. While 40%-45% of pregnancies are first-time moms, and you just don't have that, and the second is short cervix, which is fewer than 2% of women have short cervix.
So, you just don't know, so physicians didn't have before this biomarker test a good way of predicting that this mom is likely to go into labor prematurely, and over 50% of babies who are born prematurely, the moms had no risk factors altogether, so the cost of the test, of course, will vary depending on what is the coverage. We currently talk about we have a Medicare code for $750.
And if it is, but we do have a patient assistance program. So, if the mom pays for the test herself and qualifies for the patient assistance program, it's much, much, much lower. Could be as low as a hundred and some dollars. So, it's well worth it, especially because the economics, when we think about reimbursement and what payers are looking for, are actually incredibly strong.
So, to give you a few details, the number of moms needed to be screened to save one NICU day is between three and four. The cost of one NICU day is between $4,500 and $20,000 per day. And prematurity is not a very rare condition. One out of ten babies is born before 37 weeks.
So, for payers, paying for the test and then within six months, you're saving money is very, very different than genetic screening for some condition that may or may not develop decades later or cancer screening, which while dire, again, you don't know when you're going to get paid back for the screening test. Well, in pregnancy, it's actually really predictable.
So, savings on cost of care for the pregnant mom are evident. And we're unique that we have a national payer partner, Elevance, who supported us in running this pivotal trial I spoke before you joined, David, called PRIME that we just finished. They were foresightful enough to not only partner with us, they also ran a model of 40,000 of their members to show that this test saves $1,600 per member tested because we save on NICU days stay, because the test and treat model.
You got it. Yeah, that's exactly right. So, I always talk about the clinical outcomes first, first the health of the baby and the health of the mom. But of course, economics follow right behind it, because the healthier the baby, the less time in the hospital, and of course, lifelong costs are a lot less. And on average, the cost of a healthy pregnancy to the healthcare system in the United States is maybe between $1,000 and $2,000.
The cost of a premature pregnancy, on average, is over $65,000. So, in totality, out of 3.6 million pregnancies in the United States per year, it costs the system over $25 billion to care for premature. 10%. 10%. I said one out of ten. 10%, it's a lot. It's not rare. It's not rare. You can. Now you can. With the screening test and treat approach, you asked a great question.
Why isn't everybody using it? Well, of course, physicians are data-driven. You need to bring in clinical research. And that's what we've done, yeah, prove that it works, and it works across a broad spectrum of pregnant moms, different races, different ethnicities, different geographies in the United States. So, PRIME study that I spoke about, the pivotal randomized clinical trial we just finished, was run across 19 centers in the United States, over 5,000 patients.
Right about a year ago, we announced an early stoppage of the trial for success at the interim point at the advice of DSMB, which monitored it. And just to give you magnitude, we saved only 0.00256 alpha for that, which is very little for anybody who remembers statistics. It just tells you that our results are very, very exciting.
We've submitted the results for presentation in our conferences of Society for Maternal-Fetal Medicine, and just released yesterday the news that we will be presenting those results in January from the podium. We're very excited to have the results showcased in this conference, so please be on the lookout on what we'll get presented, but this is the third trial that we tested this screening stratification model plus the treatment protocol between the PREVENT study, AVERT study that I described in
Diagnostics journal published in July of this year, and now PRIME, the third study that shows exact same endpoints, so we're very excited to show that evidence to the physician community so that they feel very confident in deploying it. We're also pursuing real-world evidence studies.
We're about to start enrolling them in the study to show that it's not just in clinical trials that you get impact, but also in real world. And of course, in today's healthcare environment in the United States, there's a lot of disruption. There's a lot of issues in preterm birth, which is actually increasing in the last 10 years. March of Dimes publishes a report every year.
Sadly, we show a grade, we, United States, as D plus. And in the last 10 years, the rate of preterm birth went up from 9.4% now to 10.4%, which equates to double-digit growth on an annual basis, which is incredible given the cost to the healthcare system and the amount of innovation. Oh, it's a great question.
It depends on the price that you would assume, but let's run with 750 code that we have for Medicaid and our annual operating costs, which roughly run between $26 to 29 million per year. So, it doesn't take a lot. It takes maybe 30,000-40,000 tests. So, now the adoption is we have a revenue of roughly less than $500,000. I'll tell you why it makes little sense to put the foot on the gas of commercialization before you have the randomized clinical trial publication.
That is a massive catalytic event to educate the community. If we have a significant sales effort to publicize data that is not a randomized clinical trial, everybody will say, well, when are you going to show a multi-center nationwide strong trial, which we are finally ready to do.
I think it will begin a very exciting and unprecedented process of getting reimbursement, talking to guideline bodies on how does it fit into today's care guidelines.
Gotcha. Can you talk about the applicable guideline committee? How do you assure that you get into some sort of guidelines, and what would be the timeline for that?
Great question. ACOG, American College of Obstetricians and Gynecologists, is the preeminent body that sets the care guidelines, and Society for Maternal-Fetal Medicine, which is the specialist group in the United States that specifically cares for high-risk pregnancies, are the two bodies that set the guidelines. When you think about guideline inclusion, it's important to ask, well, are there guidelines already that may need to be modified? The good news is there are.
ACOG Bulletin 234 governs care for spontaneous preterm birth, and biomarker testing is referenced there that it's in development with the reference to our studies. These guidelines get looked at every 24-36 months, usually on the basis of new major evidence emerging. Last time this bulletin was updated was in August 2021. We're coming up on that three-year timescale.
We are excited to share the data with the Society for Maternal-Fetal Medicine and see their reaction to the clinical benefit that the test and treat strategy brings to moms and babies. Now, there are three ways the society starts modifying the care guidelines. First lever is so-called commentary letter that accompanies a presentation of research. Usually, Society for Maternal-Fetal Medicine issues about 20 or 30 of those a year.
That could be the first signal that the society is looking at incorporation into guidelines. Second level is Practice Advisory, which usually is based on a review of multiple pieces of evidence. The last is Practice Bulletin revision. There, of course, is a spectrum of precedents that exists. How quickly? You asked about the timeline. How quickly guidelines change? I'll give you the bookends. There are examples when they were changed literally within months.
That's, for example, when hypertension treatment guidelines went down based on one important study that was first presented at a conference. It got published within a few months, and the guidelines changed. That was to bring down the blood pressure of a pregnant mom from 160 over 100 to 140 over 90.
That is one example of the community moving really fast and rallying around the results of a clinical trial. When you look at NIPT, which is now a space, is neonatal testing, that took many years and actually 87 pieces of evidence to change the guidelines. It took a lot longer than a few months. There was only one pivotal RCT, but a lot of smaller pieces of evidence of lower grade in order to make the changes in the guidelines. There, it took multiple steps.
The society and the college first put the higher-risk women into the guidelines and then expanded it over time. I don't have an eight ball to say how much time will it take, but I would say our job at Sera is to rally the community of clinicians and researchers to continue studying the benefits of the test.
And we're getting a lot of interest to continue that research and publish it and generate that evidence that shows the society the benefit of this approach.
You mentioned the 10% premature rate. Can you talk about the direction of that rate? Is that going up? Is that going down? What do you think is causing that? And do you think if there is a change in trend, there would be maybe more attention to this issue?
Yeah. Unfortunately, the trend is going in the wrong direction. There's roughly double-digit growth over the last ten years. It started maybe ten years ago with 9.4% of babies born before 37 weeks of gestation, and now it's about 10.4%. So, it's stable to increasing, I would say. You asked about why it's a multifactorial problem. I'll start with shortage of healthcare staff and OBGYNs in particular.
The recent events and the legislation change on abortion has caused physicians to start moving state lines because, of course, they don't want to make a misstep. They don't want to deal with abortion where they can't, and therefore, healthcare deserts are becoming more and more prevalent. More than 30% of counties in the United States don't have access to hospital-grade obstetric care.
What that means is if there's a pregnant mom and something goes wrong in the pregnancy, there is no hospital with a NICU for hours, so that means you need even more care early in the pregnancy to understand if the mom needs to move closer to a hospital because the pregnancy may end prematurely, so I think staff shortage is one of them. I think the second one is the payment models in the United States have moved to capitation quite a bit.
Sometimes this capitated payment for the whole pregnancy may be $1,600. So, how much can be put in that fee to really ensure that the mom is educated, understands about the risks of preterm birth that are not insignificant? One out of ten. And by the way, for Black moms, it's 1.5 times that. So, 15% of pregnancies for Black moms end up in prematurity.
Fewer than 20% of moms hear about prematurity from their physician on their first visit, which is incredible because, for example, cord blood storage is a lot more prevalent. I remember in my three pregnancies, I heard about it at least 10 times, but I never heard about prematurity and the risks of that. So, we talked about these couple of factors. There's, of course, a lot more things at play. And I think awareness is unfortunately incredibly low in this country.
The current administration made a big push to make improvement in maternal care. Kamala Harris ran and CMS Innovation Center is running a big program where they selected 15 states to give federal funding for ten years for states and Medicaid to adopt innovative methods, which include better risk stratification methods in pregnancy, as well as nontraditional staffing models for care for moms like doulas, midwife, nurses, et cetera, et cetera, that are not reimbursed everywhere, but are desperately needed because there's not enough obstetric staff to care for all of the pregnancies in the United States.
Maybe you can talk about there's a lot of companies operating in women's health, but you offer something unique in an underserved market. Why do you think that the numerous companies like Natera, Ambry, Quest, Labcorp, all of that have overlooked this market?
I actually think there's a lot more attention to this market. And a lot of companies that you mentioned are building their maternal care and women's health portfolios and are starting to look with interest to this market. And I believe there will be more. Why? Because the outcomes, unfortunately, are getting more and more press. I'm sure you've seen in lay media top athletes dying from preeclampsia in today's day and age.
That's not okay. And more and more innovations like Sera's PreTRM test are becoming available. So, the combination of unmet need, innovation, and solutions that are becoming available will make it more attractive, and more and more companies will start entering this space. But the ones you mentioned, Labcorp, Quest, they're definitely entering with their maternal care testing portfolios, as well as very well-established large diagnostics players as well.
Gotcha.
Oh, should we keep going with the questions? If you have more, absolutely. There's lots of fun things to talk about. Gotcha. Well, maybe we can go back to the $750 price. What are the conversations that you're having with payers, both public and private? And are you doing any studies in terms of showing the cost-effectiveness?
Yeah, absolutely. So, in the discussions with payers, they see the value proposition very clearly. I mentioned Elevance published their study to show the $1,600 benefit per member tested. We're also using our clinical trial results and what happened in real world to update those studies. And shortly, we will put a model on our website so that smaller payers, employers can plug in their numbers and see what savings they can expect by using PreTRM test.
We will certainly publish whatever results that will become available to showcase the economic value of the strategy. When we meet with both commercial and public payers, they very quickly see the value proposition because prematurity is not that rare, and it's really, really costly, with the cost of an ICU day ranging from $4,500-$20,000 per day, especially for a really premature baby because they're on all sorts of instruments with a lot of procedures that need to be done.
The conversation with commercial payers is a little bit different. The fee-for-service plans is a little bit different than the public payers. Public payers are interested in public health approach appropriately so.
We're really excited to engage in showing what this test can do because the screening needs to be done on all asymptomatic singleton pregnancies that are otherwise healthy where no risk factor is being spelled out. If you already have previous preterm births, no test is needed because you know that that pregnancy is already at higher risk.
Gotcha. Oh, no, keep going.
No, you asked a very rich question in terms of how the discussions are going. I think all of the payers are excited to see the results from the PRIME study because they most accurately show with a randomized control and treatment arm the results that they can expect. And we look forward to sharing those results as soon as the publication becomes available.
Gotcha. Okay. In terms of go-to-market strategy, what % of payers do you think are going to be likely to adopt before guidelines?
In terms of your expectations, how are you kind of thinking about that go-to-market strategy with that in mind?
Typically in diagnostics, as you know, commercial plans are the earlier adopters because they have to live with the consequences of poor ability to screen for higher-risk pregnancies and avert the negative health outcomes. We expect a greater portion of commercial plans and fee-for-service plans to adopt the test first. And that's what we're going to focus on. Typically, public payers trail behind by a few years. We think in our case, it's not necessarily the case because the public payers have a great interest to care for the population that is at higher risk for preterm birth. Not to forget employers and moms themselves.
Employers, especially self-insured with large female populations like grocery store chains and many others who want to retain their women and their parents because prematurity means that the employee and his or her family is out for months caring for the baby, living next to the NICU. In order to have a productive workforce, there's a great opportunity to provide the benefit of covering the test. So, we're focusing on that market also.
You mentioned earlier on about the operating costs. I think you said high 20s, high 20 millions, $750 price, pretty sufficient, pretty good cost of goods sold here. But would that increase if you're increasing your sales force? And what kind of investments do you want to make on that sales force? Because obviously you have an important message, but you need to help spread that message.
Great question. So, I'll address two separately.
One is on awareness and the sales force, and another one on cost of goods because both we're focusing on with specific initiatives. Our go-to-market model is T-shaped. We believe more awareness needs to be made about the problem of prematurity in this country and that new solutions are available to help physicians because it's not that physicians don't want to screen and apply treatment. They very much do.
They just want to be confident that it works. So, we want to bring the data, and we have large-scale awareness building and education efforts for physicians across the country. That's the top of the T. Then the vertical part of the T is dedicated geographic-specific efforts with a sales force where we've got green shoots, where we've got opinion leaders or positive news on reimbursement. There we're going to invest in pull-through.
So, those are the types of sales force investments we're going to make, really push hard on some of the conversions in reimbursement and adoption by, for example, large-scale hospital systems, and then staff up behind those wins to make sure that we get a high ROI from sales force investment. So, that's on the awareness building and sales force side. On the cost of goods, this year we made two very, very important investments and achieved great results.
One is we shifted from venous blood draw through a third-party reference lab. So, for example, women would have to go and draw blood at a Labcorp to now only needing a small kit to do a finger prick blood draw in the physician's office or at home. It could be mailed to them with a request online and mailed back with ambient shipment.
That is not only a lot cheaper for the system and for us, but also incredibly more convenient for the mom and the physician. We also changed our lab analytical process to bring down the cost of goods to up to 60%. So, we're poised for scaling with our data and with these changes at a much higher profitability level. Gotcha. So, maybe we can end this just in terms of a five-year vision. Let's pretend that it's 2029. You're looking back and you're thinking, "Wow, we accomplished a lot."
Can you run us through all the different things that you accomplished? I would say number one, we got into guidelines. So now it's a mandatory test for all women without other present risk factors like previous premature birth or short cervix. Number two, we got a substantial portion of payers to issue reimbursement.
Importantly, more and more physicians are not only aware, but are following the guidelines and adopting it. We looked at many precedents of ubiquitous and very well-known tests in the market, like Panorama, Afirma, Cologuard, the staple names in the diagnostics industry. For all of them, the peak sales were achieved in the years seven to nine post really pressing hard on the commercialization. Five years from now, I'd like to be close to that peak sales, but certainly double-digit growth, stable year over year, delivering results for moms and babies and investors alike.
Thank you so much.
Thank you so much. Appreciate all the questions. Thanks.