How Mirvie Is Predicting Pregnancy Complications Before They Happen

For a century, pregnancy care has been built around a reactive model: wait for symptoms, then respond. By the time a complication like preeclampsia or preterm birth becomes clinically apparent, clinicians are often racing against the clock to protect both mother and baby.

Mirvie, a Portfolia portfolio company, is pioneering a different path—using RNA signatures from a simple blood test to predict pregnancy complications months before symptoms appear and enabling a new era of proactive, precision pregnancy care.

Why Do Pregnancy Complications Need Predictive Diagnostics Instead of Reactive Care?

Pregnancy complications are one of the most urgent and costly challenges in women’s healthcare.

• Over 370,000 babies were born preterm in 2023 in the U.S., with a national preterm birth rate of 10.4%.
• The United States received a D+ preterm birth grade for the third consecutive year, the worst in the March of Dimes report’s history.
• Preeclampsia and related hypertensive disorders now affect 1 in 12 pregnancies in the U.S., with rates nearly doubling over the last decade.
• Globally, preeclampsia contributes to over 70,000 maternal deaths and 500,000 fetal deaths annually.

The burden is not evenly distributed. Black women in the U.S. face preterm birth rates nearly 1.5x higher than the national average and maternal mortality rates 2–3x higher than white women.

Current risk assessment tools rely mainly on clinical history and demographic factors, but:

• Traditional models identify only about 20% of women who will later develop preeclampsia.
• That means 80% of cases arrive as unexpected emergencies, leading to crisis interventions, extended NICU stays, and long-term health consequences.

The economic impact is equally significant:

• Preeclampsia alone costs the U.S. healthcare system $2.18 billion in the first 12 months after delivery—roughly split between mother and infant care.
• Maternal morbidity for 2019 births cost $32.3 billion from conception through age five when including medical costs, lost productivity, and social services.

Predictive diagnostics offer a path to move from emergency response to early intervention—before complications escalate for mothers and babies.

Who Is Mirvie and What Problem Is This Pregnancy Complications Test Solving?

Mirvie was founded in 2018 to address what CEO Maneesh Jain has called an “absolutely staggering” unmet need in pregnancy health.

The origins of the company trace back to Stanford University, where:

• Dr. Stephen Quake began groundbreaking research on cell-free RNA in pregnancy after the premature birth of his own daughter.
• Quake is also known for inventing non-invasive prenatal testing (NIPT) for chromosomal abnormalities, now used by millions of expectant families worldwide.

Mirvie builds on that legacy but targets a far larger problem:

• Chromosomal disorders like Down syndrome affect <1% of pregnancies.
• Complications such as preeclampsia, preterm birth, and gestational diabetes affect ~1 in 5 pregnancies globally—around 45 million women each year.

The leadership and investor base underscore the ambition:

• Founding Board Chair Stanley Lapidus founded Exact Sciences and invented the ThinPrep Pap test, now the standard in cervical cancer screening.
• Chief Medical Advisor Dr. Michal Elovitz brings deep maternal-fetal medicine and translational research expertise.
• Mirvie has raised $114 million from investors including BlackRock, the Gates Foundation, Khosla Ventures, General Catalyst, Foresite Capital, and GV.

Mirvie’s goal: predict and help prevent pregnancy complications before they become emergencies, at scale.

How Does Mirvie’s RNA-Based Pregnancy Test Work?

The Mirvie RNA platform takes a fundamentally different approach to pregnancy monitoring.

Traditional prenatal tools:

• Look at static markers, or
• Wait for physical symptoms to appear

Mirvie’s test instead analyzes cell-free RNA (cfRNA) circulating in a pregnant woman’s blood to understand what is happening at the molecular level across the entire maternal–fetal–placental system.

A Molecular Snapshot of Pregnancy Health

Here’s what makes the approach powerful:

• Around 25% of maternal blood flows to the placenta with each heartbeat.
• As blood circulates, RNA from the mother, baby, and placenta is released into the maternal bloodstream.
• These RNA “messages” reflect real-time gene expression—a molecular snapshot of pregnancy health from a single blood draw.

Mirvie’s platform:

• Analyzes over 22,000 RNA transcripts per patient
• Uses advanced machine learning
• Compares signals against a database of nearly 11,000 pregnancies—the largest molecular study of its kind

By detecting deviations from healthy pregnancy patterns, Mirvie can identify elevated risk for specific complications months before symptoms appear.

This enables what Mirvie calls precision pregnancy care: tailored monitoring and interventions based on each pregnancy’s unique biology, not just broad risk categories.

Which Pregnancy Complications Can Mirvie Predict Before Symptoms Appear?

Mirvie’s most advanced application today is preeclampsia prediction.

• In April 2025, Mirvie published breakthrough results in Nature Communications showing its RNA-based blood test can predict preeclampsia months before symptoms appear.
• The test is administered between 17.5 and 22 weeks of gestation, aligning with the routine fetal anomaly scan many pregnant women already receive.

Key performance data:

• Identified 91% of pregnancies that would develop preterm preeclampsia in women aged 35+ without pre-existing high-risk conditions.
• A low-risk result gives a 99.7% probability of not developing preterm preeclampsia.
• This represents roughly a 15-fold improvement compared to clinical and demographic risk models alone.

Beyond preeclampsia, Mirvie’s platform has shown predictive capabilities for:

• Severe fetal growth restriction (as presented at the Society for Maternal-Fetal Medicine)
• Spontaneous preterm birth, with earlier studies demonstrating prediction about two months in advance

The platform can predict ~75% of preterm births, compared to the ~20% identified by current clinical risk models.

Why Early Prediction Matters

For preeclampsia, timing is everything:

• The U.S. Preventive Services Task Force recommends low-dose aspirin for women at high risk.
• When started before 16 weeks, aspirin can reduce preeclampsia risk by 24% and preterm birth risk by 14%.
• Yet current risk assessment tools miss most women who would benefit.

Mirvie’s test offers a way to identify truly high-risk pregnancies early enough for prevention and closer monitoring to make a meaningful difference.

What Do Clinical Studies Tell Us About Mirvie’s Impact on Maternal Health?

Mirvie’s evidence base is anchored in the Miracle of Life (MoL) prospective study—the largest molecular study of pregnancy health ever conducted.

The study:

• Analyzed nearly 11,000 diverse pregnancies across 11 U.S. medical centers
• Measured 22,000 cfRNA transcripts per patient
• Generated over 200 million data points

The April 2025 Nature Communications publication revealed a major scientific insight:

• Preeclampsia is not one disease but is associated with at least two distinct molecular subtypes
  • One more placenta-driven
  • One more immune-system-driven

These subtypes share similar clinical presentations but differ biologically—one reason preeclampsia has been so difficult to predict and treat as a single entity.

Mirvie’s RNA signatures can distinguish these subtypes, enabling more precise risk stratification and the potential for more targeted interventions over time.

The study also showed:

• Accuracy across real-world populations and settings
• Performance that is independent of maternal age, BMI, and race—a critical point given existing risk models often underperform in diverse populations

Mirvie’s clinically validated blood test will be available under the brand name Encompass™. As Dr. Thomas McElrath, Mirvie’s VP of Clinical Development and a maternal-fetal medicine physician at Brigham and Women's Hospital, has noted: reactive care has been the default for 100 years—this platform offers a credible path to proactive care.

How Big Is the Market Opportunity for Predictive Pregnancy Diagnostics?

Predictive pregnancy diagnostics sit at the intersection of multiple high-growth segments.

• The global women’s health diagnostics market was valued at ~$21 billion in 2024 and is projected to reach $31–42 billion by 2030–2034, growing at ~6–7% annually.
• Prenatal testing is one of the fastest-growing segments, driven by rising maternal age, increasing healthcare spend, and more advanced diagnostics.

On the cost side:

• NICU stays average around $3,000 per day, with extremely premature infants often generating bills exceeding $100,000.
• A pregnancy complicated by preeclampsia costs $41,790 in combined maternal and infant care in the first year, versus $13,187 for an uncomplicated pregnancy—more than triple the cost.

The value proposition for predictive diagnostics extends across:

• Health systems and payers – fewer emergency interventions, NICU admissions, and long-term complications; Mirvie estimates potential healthcare cost reductions of up to 65%.
• Families – healthier babies, fewer traumatic emergencies, and reduced long-term health consequences.
• Employers – lower disability claims and productivity losses tied to maternal morbidity.

Despite the scale, maternal health has historically been underfunded compared to other disease areas—even though conditions like preeclampsia are growing faster than diabetes, heart disease, Alzheimer’s disease, obesity, and chronic kidney disease. That gap is both a market inefficiency and an investment opportunity.

How Does Mirvie Fit Portfolia’s Women’s Health Investing Thesis?

Portfolia pioneered women’s health investing and is now the most active investor globally in the category, with 46+ portfolio companies and 100+ investments.

Our thesis focuses on companies that:

• Address large, high-burden conditions where women are underserved
• Build infrastructure-level platforms, not just single-point products
• Combine strong clinical evidence with clear economic value for the system

Mirvie fits this thesis on multiple levels:

• It is an infrastructure play in pregnancy: a platform that can generate insights across preeclampsia, preterm birth, fetal growth restriction, and beyond.
• The Miracle of Life dataset—200 million data points across 11,000 pregnancies—is a strategic asset that supports future products and indications.
• It complements other Portfolia investments across the reproductive continuum, from fertility and IVF to maternal health and menopause.

Pregnancy affects approximately 140 million women globally each year. A predictive test that:

• Can be administered as part of standard prenatal care
• Has strong clinical validation
• Delivers clear cost savings

is positioned to become a standard of care—similar to NIPT’s trajectory in chromosomal screening.

What Should Investors Look For When Evaluating Predictive Pregnancy Companies?

Predictive pregnancy diagnostics look promising on the surface; the real differentiation lies in the details. Key questions for investors include:

1. Is the Clinical Evidence Strong and Prospective?

Investors should prioritize:

• Prospective studies in diverse populations, not just retrospective analyses
• Clear performance metrics:
  • Sensitivity
  • Specificity
  • Negative predictive value

Mirvie’s 91% sensitivity and 99.7% negative predictive value for preterm preeclampsia in key populations set a high benchmark.

2. Is the Business Model and Reimbursement Pathway Clear?

In diagnostics, economics matter as much as accuracy:

• Is there a clear path to reimbursement?
• Are payer or health system partnerships in development?
• How does the test integrate into existing prenatal workflows?

Mirvie’s timing (17–22 weeks) aligns with visits and scans most pregnant women already have, reducing friction for adoption.

3. Is the Data Strategy a Real Moat?

Leading companies build data assets that compound over time:

• Proprietary datasets
• Deep clinical annotations
• Evidence that new products and indications can be derived from the same platform

Mirvie’s MoL study is a strong example of this kind of data moat.

4. Does the Team Have the Right Mix of Expertise?

Differentiated teams include:

• Maternal-fetal medicine and OB/GYN expertise
• Regulatory and diagnostics commercialization experience
• Deep technical skills in genomics and machine learning

Mirvie’s mix of academic pioneers, clinical leaders, and commercial operators reflects the multi-disciplinary requirements of this space.

Why Is Mirvie a Signal for the Future of Predictive Health in Women’s Care?

Mirvie is more than a pregnancy test—it points to where women’s healthcare is heading.

Pregnancy is an ideal entry point for predictive health because:

• There are frequent, structured clinical touchpoints.
• Blood draws and routine monitoring are already standard.
• Women are highly motivated to act on health information during this time.

The implications extend beyond childbirth:

• Women who experience preeclampsia have elevated cardiovascular risk later in life.
• Molecular signatures identified during pregnancy may inform lifelong preventive care for heart disease and other conditions.
• Platforms like Mirvie’s could eventually support broader maternal and cardiovascular risk prediction across the lifespan.

For investors, Mirvie is a signal that predictive, RNA-based, and data-rich platforms are poised to rewrite standards of care in women’s health—starting with pregnancy, but not ending there.

How Can Investors Partner With Portfolia to Back the Next Wave of Maternal Health Innovation?

Portfolia offers investors a purpose-built way to participate in the next generation of maternal and women’s health innovation.

Through our women’s health funds, investors gain:

• Diversified exposure to companies across the female healthspan—from fertility and pregnancy to menopause and longevity
• Access to curated deal flow informed by deep clinical, scientific, and operational experience
• Participation in a community of 2,000+ investors who provide feedback, networks, and distribution support for portfolio companies

Our diligence on companies like Mirvie goes beyond surface metrics. We evaluate:

• Clinical evidence quality and regulatory pathways
• Reimbursement and payer strategies
• Competitive landscape and defensibility
• Alignment with closing the gender health gap at scale