Mirvie

RNA-powered Pregnancy Insights

Andrew Kuzemczak
May 20, 2025

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Welcome to the 9 new subscribers who have joined Future Human since our last edition! Join 182 other leaders learning about the future of human health by subscribing here:

Hi friend,

Welcome back to Future Human! Last week, we sent what I thought was one of our best pieces yet. It probably had to do with the fact that I was finishing our oncology unit while writing about the future of the space, but wow was it inspiring. I hope you appreciated it just as much!

This week, we have a special edition, a newsletter informed by another founder interview. Last month, I was contacted by Dr. Maneesh Jain, CEO and Co-founder of Mirvie. In just a few sentences, he had me hooked. Put simply, the journey into parenthood too often begins in the dark: vague risk assessments, reactive care, and preventable complications that leave families blindsided. Despite its profound impact on health, society, and equity, pregnancy remains a black box in modern medicine. But that’s starting to change, and his team is leading the charge.

So with that, let me ask you:

If your body held molecular clues that could predict a complicated pregnancy before the first symptom appeared—would you want to know? And more importantly, would you trust them?

The Story

Life’s biggest moments shift with time—graduations, first jobs, weddings. But few would argue that the day you become a parent does not belong near the top. At the same time, if you are a subscriber of Future Human, I would venture to guess you understand at least broadly the level of risk that comes with pregnancy, even in the modern era. Postpartum hemorrhage, infection, preterm labor, and gestational diabetes are all top of mind for a physician and a soon-to-be mother. Among expectant mothers worldwide, however, few conditions are as feared as preeclampsia.

Surely then, we must understand most that there is to know about the condition so dreaded in obstetrics?

Far from it…

Preeclampsia is a pregnancy-specific condition characterized by high blood pressure (hypertension) and protein in the urine (proteinuria) that develops after 20 weeks of gestation. It likely originates from abnormal placental development. Defects in the arteries can lead to placental ischemia, which triggers the release of anti-angiogenic factors (substances inhibiting formation of new blood vessels) into the maternal circulation. These foreign products drive a deadly reaction, accounting for 70,000 deaths annually, or 14% of all maternal deaths.

In 2018, two brilliant minds sat with this issue and demanded more. After experiencing traumatic deliveries of their own children, Drs. Maneesh Jain and Stephen Quake set out to better understand what was going on and how we could better predict it.

“This is the most important moment in people’s lives, and yet we understand so little.”

Maneesh Jain, PhD, CEO and Co-founder of Mirvie

Dr. Jain's prior work at Grail and Celera taught him that molecular signals can be detected from blood well before disease manifests. Dr. Quake, a Stanford bioengineer, had the research background in RNA to help support this understanding with a technical solution. Soon came Mirvie.

Mirvie set out to build a solution designed to predict pregnancy complications—such as preeclampsia—months before symptoms appear. The company’s RNA platform technology utilizes a simple maternal blood test to analyze cell-free RNA (cfRNA), providing a window into the unique biology of each pregnancy.¹^,²

In my interview with Dr. Jain, he pointed out that despite enormous advances in areas like oncology and cardiology, pregnancy care remains largely reactive. We largely “hope for the best.” Preeclampsia, preterm birth, and fetal growth restriction all emerge during pregnancy but are largely unpredictable.

As is widely discussed in medicine, we must shift the system from reactive to preventive care. Mirvie is doing just that. Mirvie enables prediction and early action in obstetrics just like in cancer or cardiovascular disease.

In medical school, I hear providers and executives speak about the need to adopt a preventive model. Pregnancy complications are among the clearest examples of why. It is refreshing to see a brilliant duo delivering tangible tools to make this paradigm shift possible.

The Tech

Prepare for sci-fi. Based on Dr. Quake’s work at Stanford, Mirvie developed the first RNA-based blood test to predict pregnancy complications months before symptoms. The most inquisitive among you may be asking: how, exactly, is this possible?

Here is my attempt to break it down.

Unlike DNA, which is binary and static, RNA reflects the dynamic, real-time biology.

“RNA is messier, but it’s the right tool. Pregnancy is the fastest developing state in human biology.”

Maneesh Jain, PhD, CEO and Co-founder of Mirvie

To state the obvious, if you want to transform a sensitive and medically intensive sector like obstetrics, your science must be robust. In that regard, Mirvie seems to have left no stone unturned.

In 2018, their first work arrived, a pilot study from Dr. Quake’s lab in Stanford. Published in Science, the paper demonstrated that RNA profiles accurately classified women who delivered preterm up to 2 months in advance using a simple blood sample. By analyzing nine cfRNA transcripts from the placenta, researchers accurately estimated gestational age in 31 healthy pregnancies. The accuracy was comparable to first-trimester ultrasounds, offering a cost-effective alternative. In a related study involving 38 women at elevated risk for preterm delivery, seven cfRNA transcripts were identified that could predict preterm births up to two months in advance with 82.6% accuracy. This predictive capability surpassed existing methods like cervical length measurement and fetal fibronectin testing.³

With the science published and a company founded, they needed to validate those first findings. In January of 2022, they published in Nature their new approach to prenatal care by utilizing plasma cell-free RNA (cfRNA) profiling to predict preeclampsia, well before symptoms emerge. By analyzing cfRNA from a single maternal blood draw, the retrospective study achieved a 75% sensitivity and a 32.3% positive predictive value in predicting preeclampsia, outperforming accepted methods. The cfRNA signatures were found to be independent of clinical factors such as maternal age, body mass index, and race, meaning the test can predict complications based on real-time signals, not just demographics or medical history.⁴

Fast forward to now, where just last month they published prospective data confirming their test’s predictive power across diverse, real-world settings. The April article in Nature Communications showed that their blood test can identify 91% of pregnancies that will develop preterm preeclampsia in women aged 35+ without pre-existing high-risk conditions four months before symptoms. Those with a low-risk result had a 99.7% probability of not developing preterm preeclampsia. Using data from >9,000 pregnancies, they validated certain RNA signatures that can distinguish between severe (placental-driven) and mild (immune-driven) hypertensive disorders of pregnancy, including preeclampsia.⁵

The Mirvie RNA platform has now been used in over 11,000 pregnancies, with its machine learning algorithm running through 200M+ RNA data points. Although preeclampsia remains the first frontier, the company is also exploring predicting additional pregnancy complications, with research demonstrating the success of Mirvie's technology in predicting spontaneous preterm birth and severe fetal growth restriction.⁶

For those wondering how to get your hands on this tech, they announced their launch just last week. The clinically validated blood test is now available under the brand name Encompass™ (encompasstest.com). It combines the blood test with a preventive action plan and a responsive virtual assistant to offer individualized support for preeclampsia.

They have launched Encompass™ across the U.S. with an easy, patient-initiated online purchase process. You get telehealth clinician review, mobile phlebotomy, and results delivered within 10-14 days.⁷

Okay, there you have it. A bit of a dense tech section, but to make this big of a leap, we had to know the science was strong.

The Market

Medicine has made undeniable progress in the previous decades, but that progress has not been shared equally by all disease states and patient populations. Despite all the innovation, preeclampsia rates have doubled in 15 years. Sure, improved diagnosis may be a factor, but even then the current rate of 1 in 12 pregnancies is expected to reach 1 in 10 by 2028. By our current standards, nearly 80% of pregnancies fall into the “moderate risk” category (e.g. first-time, Black, BMI>30, >35 years old, low income).

“The biology is strongest exactly where the unmet need is greatest.”

Maneesh Jain, PhD, CEO and Co-founder of Mirvie

The global preeclampsia market reached a $725 million valuation in 2024. It is expected to grow to $880 million by 2035. Although this is not the biggest market we have assessed, it is no less critical. Additionally, the broader prenatal care market, which Mirvie can expand into, is much larger. Prenatal care worldwide is valued at $3.90 billion, growing quicker with a CAGR of 6.10%. The increasing prevalence of reproductive health problems is propelling market demand for care. Public health campaigns aimed to improve maternal and child health are key factors driving growth.⁸^,⁹

Mirvie operates in the non-invasive maternal-fetal health diagnostics space, but is also adding customer- and provider-centric support experiences that have been more the hallmark of digital health products. Unlike those who test for and diagnose conditions after symptom onset, Mirvie predicts risk so reduction or prevention is possible. They are the only validated preeclampsia test in asymptomatic populations. With that said, it is still valuable to explore what potential competitors exist and if their tech is at all similar or just complementary.

Thermo Fisher Scientific: offers an FDA-cleared immunoassay measuring the sFlt-1/PlGF ratio, a biomarker used to assess the short-term risk of preeclampsia (targeted for use between 23 and 34 weeks of gestation to aid clinical decisions in high-risk pregnancies)¹⁰
Roche: developed the Elecsys sFlt-1/PlGF ratio test, also FDA-cleared, for the same gestational window and biomarker-based risk stratification (helps differentiate preeclampsia from other hypertensive disorders in pregnancy)¹¹
Sera Prognostics: focuses on proteomic blood tests like PreTRM, which predicts risk of preterm birth, including cases related to preeclampsia (includes machine learning approach to analyze proteins in maternal blood for early risk assessment around ~19–20 weeks)¹²

If it was not clear, none of the competitors focus on RNA in their current diagnostic products for pregnancy complications. Thermo Fisher and Roche use protein biomarkers—specifically the sFlt-1/PlGF ratio, which involves angiogenic proteins, not genetic material. Sera Prognostics' PreTRM test is based on proteomics, analyzing circulating proteins, not DNA or RNA. Separately, all but Sera are only effective later in the pregnancy. The Mirvie RNA test is designed for use between 17.5 and 22 weeks of gestation, aligning with the standard prenatal anomaly scan.

Mirvie represents a refreshing approach to a critically important and underserved community. They are surrounded by more complementary tech than adversarial, but even if it was the opposite, their tech and science seem truly hard to beat.

The Sick

Pregnant women are normally told they are at risk for preeclampsia for vague reasons, like their weight or race. Often they are not convinced, as they are symptom-free and have not been provided personalized reasoning. Mirvie opens the door for targeted and biology-based analysis.

Preeclampsia is the leading cause of maternal and neonatal ICU admissions. Alongside those 70,000 maternal deaths per year come 500,000 fetal or newborn deaths. This “risk” is not to be taken lightly, so we must offer each patient the details they need to treat it seriously.

With preeclampsia affecting upwards of 8% of pregnancies worldwide, not only do the mothers need help, so do the OBGYNs. Most OBGYNs see 30-40 patients/day. If 80% are flagged as “moderate risk”, there is little ability to triage effectively. Mirvie’s Encompass™ narrows the list to 1 in 4 patients needing added attention. In the physician-patient workflow, Mirvie’s preventative care plans help support clinical decisions and the communication of instruction. The virtual assistant helps patients adhere to evidence-based interventions and complements recommendations offered by their OBGYN. Mirvie is not simply the diagnostician at the start. It subsequently fills in as the administrator for the remainder of the patient experience.¹³

As always, I love considering what the future holds.

Hence the name…

I mentioned above how these RNA signatures could help identify other conditions including spontaneous preterm birth, fetal growth restriction, etc.

According to the World Health Organization, approximately 15 million babies (10%) are born prematurely each year globally. It may appear as a stretch to think our RNA can tell us how likely our baby is to deliver early, but I bet you would have said the same thing for preeclampsia. Look where we are now. Supporting mothers through birthing complications is a universally shared priority. To now be able to offer that support early, preventively, and non-invasively would have been a dream a few years ago.¹⁴

For moms and babies everywhere, I hope Mirvie validates its science in as many conditions as possible.

The Economy

Pregnancy is expensive and complications do not simply add on, they multiply. In the US, the annual costs of preeclampsia are about $2.18 billion in the first year after delivery. In 2019, Biora Therapeutics, a biotechnology company out of San Diego, looked to see how the cost of pregnancy complicated by preeclampsia compared to an uncomplicated cohort. Well, the results may shock you.

The mean combined maternal and infant medical care costs in the uncomplicated cohort was $13,187 (P<.001). The preeclampsia cohort… $41,790. A multiple of 3.2. What is more shocking, when you separate infant costs from maternal costs, you find the mean infant cost in the preeclampsia cohort was $28,898, while in the uncomplicated cohort just $3,669. Nearly 8x more.¹⁵

The impact on the infant propels the cost much more than that to the mother. Avoiding even a fraction of NICU admissions and severe maternal complications would save billions. Preventive care means fewer ER visits, shorter stays, and healthier moms and babies.

Next, preeclampsia is not an isolated episode with no long term effects. Mothers have an 8x higher cardiovascular mortality after preeclampsia. The link from the condition to heart disease is well established, so it would behoove us all to prevent preeclampsia not just for the short term impact, but also to avoid the long term burden.

I do not need to remind you all of the global cost of cardiovascular disease. I think I have covered it in half our newsletters at this point.

Preventive care is not some new phenomenon in obstetrics. For example, we know low-dose aspirin can prevent preeclampsia, but it is only taken in ~10% of moderate-risk cases. Physicians lack a framework for when to initiate or avoid specific regimens. Mirvie’s Encompass™ can clarify who needs what and when, improving physician satisfaction and patient adherence.

Although Mirvie is rapidly chasing insurance coverage, it will take some time (shoutout USA). In the interim, I am happy to see they have taken an easy, online purchase approach. I will be watching closely to see how their sales model develops.

My Thoughts

In a world where pregnancy is still treated as a mystery box of outcomes, Mirvie is handing clinicians and patients a much-needed flashlight—and RNA is the bulb. With science robust enough to spot preeclampsia before it starts and a mission rooted in empathy, Mirvie is not just decoding pregnancy complications, it is rewriting the expectations.

I am immensely grateful to Dr. Jain, Dr. Quake, and the entire Mirvie team for letting me chat with them for this edition of Future Human. In their hands, the future of maternal health is not only more predictable, but also brighter and profoundly more human.

To more lives saved,

Andrew

I always appreciate feedback, questions, and conversation. Feel free to reach out on LinkedIn @andrewkuzemczak.

Mirvie

RNA-powered Pregnancy Insights

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The Story

The Tech

The Market

The Sick

The Economy

My Thoughts

References