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The #1 complication of childbirth: The crisis hiding in plain sight

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By Dr. Jennifer L. Payne and Alisa Marie Beyer

Postpartum depression (PPD) isn’t just the “baby blues.” It’s the most common complication of childbirth, affecting 1 in 5 new mothers, and yet it remains dangerously underdiagnosed, misunderstood, and too often untreated.

Baby blues vs. postpartum depression

Up to 80 per cent of new moms experience the baby blues: brief emotional shifts, crying, irritability, mood swings, that typically resolve on their own within 1–2 weeks after birth. But PPD is different. It’s a serious medical condition that can begin during pregnancy or emerge weeks or months after delivery. It lasts longer, hits harder, and requires clinical care.

The Impact of PPD:

  • 50 per cent of women with PPD receive no treatment
  • PPD contributes to nearly 1 in 4 maternal deaths
  • It costs the United States US$14+ bn annually in healthcare

Many women don’t recognise what they’re experiencing. Others are too overwhelmed, ashamed, or unsupported to seek help. Meanwhile, our healthcare system is still rooted in reactive models that rely on self-reporting, often when a mother is already in crisis.

A predictive breakthrough: Introducing myLuma

At Dionysus Health, we believe mothers and babies deserve better. That’s why we developed myLuma, the first clinically validated prenatal blood test that predicts a woman’s risk of developing PPD as early as 28 weeks into pregnancy.

Why this matters: A shift from reactive to predictive

Traditionally, PPD is diagnosed after symptoms appear often late, inconsistent, and subjective. myLuma changes the timeline. It gives providers a clear, scientific window into risk before birth so they can prepare personalized support and interventions before a crisis hits.

How it works: The science behind the test

The core of myLuma is epigenetics: the study of how stress and environment affect gene expression without changing the DNA itself. During pregnancy, a woman’s body undergoes massive hormonal, neurological, and emotional changes. These shifts leave molecular fingerprints – biomarkers – in the blood. Using these markers, myLuma predicts PPD with up to 85 per cent accuracy.

Our scientific journey:

  • 2014–2020: Discovery of epigenetic biosignatures linked to PPD
  • 2020–2022: Patent filings, US$4.5m NIH funding, and clinical validation in 600+ patients
  • 2022–2024: Biomarker-brain function mapping, U.S. patent secured, and national accelerator support
  • 2025: Awarded US$10m by the Department of Defense to expand clinical trials and pursue FDA approval

So… is this really the first blood test to predict PPD?Yes. Thanks to a decade of innovation in molecular diagnostics, AI-powered analytics, and epigenetic discovery, myLuma offers a new lens into maternal mental health that was never before possible.👉 It’s a third-trimester blood test.
👉 It offers early, personalised insights.
👉 It empowers OBs, midwives, and health systems to intervene before it’s too late.

The solution: Prediction + care coordination

Prediction alone isn’t enough. That’s why Dionysus Health has partnered with Mammha, a leading perinatal mental health platform, to ensure every woman flagged as high risk is met with wraparound support: behavioral health, therapy, doula access, medication planning, and more.

This new model combines biological insight + human support: a proactive care plan tailored to each mother’s unique needs.

What Is a clinical study—and what’s live now?

A clinical study is a carefully designed research trial used to evaluate the safety, effectiveness, and real-world impact of a medical test or treatment. Right now, Dionysus Health is leading two major studies, funded by the U.S. Department of Defense, to validate the clinical utility of our test, myLuma™, the first prenatal blood test that predicts a woman’s risk of PPD.

Study #1: PREVAIL (UVA + Inova Health System) is a 1,000-participant study evaluating how the availability of biological risk information for PPD during pregnancy might influence healthcare decision-making and patient outcomes.

The study follows participants from their third trimester through postpart

um to assess impacts on referral patterns, treatment engagement, and depression symptoms. This information is being used solely for research purposes and is not intended for clinical decision-making outside of the study.

Study #2: BRAVE: This observational study follows 1,000 pregnant women using both blood and saliva samples, testing the accuracy of the myLuma biomarkers without sharing results with participants or doctors.

It’s designed to validate the algorithm, strengthen the FDA approval pathway, and expand accessibility—especially for underserved populations or those in rural areas.

Together, these studies are paving the way for myLuma to become the first-ever biological test to predict a mental health condition before symptoms appear, a potential game-changer in maternal care.

Setting the standard in maternal mental health

PPD has long been an invisible crisis. With myLuma, we’re finally changing that. This isn’t just a test, it’s a paradigm shift.

Because when we see it coming, we can act sooner, intervene smarter, and help moms thrive, not just survive.

The path ahead

myLuma launches commercially in October 2025, with clinical pilots already underway in OB and IVF clinics in California, Florida, and Texas.

Together, we can rewrite the postpartum story for millions of women.

Because when mothers thrive, families flourish, and the entire healthcare system benefits.

About the authors

Dr. Jennifer L. Payne is the chief medical officer at Dionysus Health and a leading psychiatrist and researcher in reproductive mental health. She is the founder of the Women’s Mood Disorders Center at Johns Hopkins, vice chair of research at the University of Virginia, and director of the Reproductive Psychiatry Research Program at UVA.

Alisa Marie Beyer is a healthcare executive, birthing professional, and entrepreneur with over 20 years of experience bridging birth and business. As chief operating officer of Dionysus Health, she leads commercial strategy for myLuma, a pioneering prenatal test predicting postpartum depression risk. She also founded Let’s Talk Birthy, providing childbirth education for first-time moms.

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Congress urged to invest over $20bn to close women’s health gap

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Congress is being urged to invest US$20bn over 10 years to close the women’s health gap.

The American College of Obstetricians and Gynecologists, the Society for Women’s Health Research and the Women First Research Coalition have unveiled the National Strategy to Close the Women’s Health Gap.

The framework calls for a coordinated national effort to improve women’s health research, care and outcomes.

It says women make up more than half of the US population, but their health needs across conditions and life stages have been understudied and underserved for decades.

Kathryn Schubert, president and chief executive of the Society for Women’s Health Research, said: “The women’s health gap has persisted for far too long.

“This strategy offers Congress a road map to improve health outcomes, drive innovation, and build a healthier future for women, families, and communities.”

The strategy notes that Congress required women to be included in National Institutes of Health-funded clinical research through the NIH Revitalization Act in 1993.

However, it says major gaps remain in women’s health research, clinical care and how evidence is put into practice.

The plan proposes US$7bn for research and innovation, including expanded federal investment in women’s health research across the NIH, VA, DoD and the Advanced Research Projects Agency for Health.

It would also establish a Women’s Health Research Interdisciplinary Fund at the NIH and create a national network of Women’s Health Centers of Excellence.

The centres would aim to accelerate the translation of research into clinical care and serve as training sites for researchers and clinicians.

A further US$1bn would be used for regulatory coordination and modernisation, including cross-agency collaboration and work to address sex differences in drug and treatment approvals.

Sex differences are biological differences between females and males that can affect disease risk, symptoms, treatment response and side-effects.

The funding would also support updated NIH tracking systems for women’s health research investment and publication standards on how sex as a biological variable is considered in research.

The strategy calls for US$4bn for data and evidence infrastructure, including a public-private partnership focused on women’s midlife health data.

It would also convene a public workshop to review existing women’s health research datasets and develop common data elements to fill gaps and make datasets more widely available.

Another US$7bn would go towards strengthening the clinical and research workforce.

This would include career pathways, loan repayment programmes, a women’s health clinical workforce loan repayment programme modelled on the National Health Service Corps and interdisciplinary training.

The workforce measures would include particular emphasis on rural and underserved areas.

The final US$1bn would support public awareness and education campaigns to improve health literacy, preventive care and participation in women’s health research.

Health literacy means a person’s ability to find, understand and use health information to make decisions about care.

The campaigns would use digital and traditional media developed in consultation with patient advocacy organisations and relevant medical societies.

Sandra E Brooks, chief executive of the American College of Obstetricians and Gynecologists, said: “Closing the women’s health gap requires not only funding research, but also investment in the people who conduct that research and those who translate research findings and discoveries into better patient care.

“Strengthening the women’s health research and clinical workforce is critical to accelerating the innovation needed to improve health outcomes for women.”

The strategy says women have higher annual out-of-pocket healthcare costs than men and live 25 per cent of their lives in poorer health.

Supporters say this strengthens the economic and public health case for long-term congressional investment.

The framework has been endorsed by organisations across women’s health, ageing, heart disease, autoimmune disease, cancer, reproductive medicine and neurological conditions, including the Women’s Alzheimer’s Movement at Cleveland Clinic, the National MS Society and UsAgainstAlzheimer’s.

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Hormonal health

Stardust period tracker shares health data, study reveals

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Stardust shared sensitive period tracking data with third-party analytics firms, according to new privacy research from Mozilla.

The findings expose a privacy divide in femtech, where users often trust apps with highly sensitive reproductive health information.

The research was carried out by Mozilla’s Privacy Not Included team, which tested several period tracking apps.

It found that Stardust, a period tracker used by millions, shared users’ reproductive health data with analytics companies, a practice the research said contrasted with its privacy-first marketing.

Analytics companies collect and examine information about how people use digital products, often to help businesses understand user behaviour or improve marketing.

The findings raise questions about whether privacy promises made by health apps match what happens to users’ data.

According to research reported by TechCrunch, one other period tracking app tested by Mozilla received what researchers called a “squeaky clean” rating, suggesting similar services can operate without sharing sensitive health data in the same way.

Period tracking apps have come under greater scrutiny in the US since the 2022 overturning of Roe v Wade, which removed federal constitutional protection for abortion.

Some users and privacy advocates have warned that menstrual and reproductive health data could potentially be sought in legal cases.

The research also points to a broader regulatory problem for consumer health apps.

In the US, many health apps are not covered by HIPAA, the health privacy law that applies to medical providers and some healthcare organisations.

That means some consumer apps may be able to collect, share or monetise sensitive health data under rules that differ from traditional healthcare privacy protections.

The femtech market, estimated in the report at US$50bn, has grown quickly, but privacy regulation has not always kept pace with app development.

Stardust had not publicly responded to Mozilla’s findings at the time of the original report, and its privacy policy remained live on its website.

The issue is particularly sensitive for period tracking because the data can reveal patterns around fertility, pregnancy, contraception and reproductive health.

Mozilla’s wider Privacy Not Included initiative has examined consumer technology products for privacy and security concerns since launching in 2017, including connected devices, children’s toys and health apps.

The findings come as US lawmakers continue to debate stronger federal privacy rules for sensitive health information collected by consumer apps.

The American Data Privacy and Protection Act, which has been stalled in Congress since 2023, includes provisions addressing sensitive health information collected by consumer apps.

Experts have also warned that anonymised health data can sometimes be re-identified when combined with other information, such as location data.

Re-identification means linking supposedly anonymous data back to a specific person.

A 2019 study found that menstrual cycle data combined with location information could identify individual users with high accuracy.

State-level privacy laws in places such as California, Virginia and Colorado have also given consumers new rights around personal data, although enforcement can vary.

Privacy advocates say the research underlines the need for clearer data practices, stronger safeguards and greater transparency in femtech.

For users, the findings are a reminder that health apps do not automatically protect health information in the same way as healthcare providers.

The report suggests period tracker companies that put privacy first may be better placed to build trust in a market where long-term use depends on confidence.

Mozilla’s investigation suggests privacy promises in femtech do not always match practice, and that period trackers can function without sharing sensitive user data in the same way.

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Juno Bio secures US$3.8m for precision diagnostics

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Juno Bio has secured US$3.8m to expand its diagnostics platform for vaginal health and reproductive care.

The funding round was led by Ada Ventures, with participation from Artesian, Entrepreneur First and Illumina Accelerator.

The women’s health startup said the seed funding will support the launch of its first CLIA-certified sequencing laboratory in Oakland, California, and a new clinical vaginal microbiome and STI test for healthcare providers.

CLIA certification refers to US laboratory standards for testing human samples used in diagnosis, prevention or treatment decisions.

Dr Leighton Turner, co-founder and chief scientific officer of Juno Bio, said: “The vaginal microbiome is still one of the least understood systems in the body at a clinical scale.

“With our lab, we’re starting to build a measurement standard that clinicians can actually use.

“We believe the level of detail from this kind of testing can meaningfully improve how vaginal healthcare is provided.”

The company is developing precision diagnostics for vaginal health, where patients can experience recurring symptoms, inconsistent diagnoses and treatments based on trial and error.

Juno Bio said bringing testing in-house gives it greater control over the process, from sample handling to results, while allowing it to refine its technology and build what it says is one of the largest datasets focused on the vaginal microbiome.

The vaginal microbiome is the community of bacteria and fungi that naturally live in the vagina. Changes in this balance can be linked to infections, symptoms and wider reproductive health issues.

Juno Bio’s newly launched clinical test examines the wider vaginal microbiome and screens for four common sexually transmitted infections, or STIs.

Rather than looking for a single cause, the test is intended to give clinicians a broader picture of what may be contributing to symptoms.

Juno Bio says this matters because multiple infections can occur at the same time and microbiome changes may be linked to fertility, menopause or recurrent infections.

Dr Anna Powell of Johns Hopkins said: “Vaginal microbiome testing has the potential to significantly reshape how we understand and manage vaginal health, particularly for patients with recurrent or unexplained symptoms.

“While the field is still evolving, advances in sequencing and data interpretation are moving us closer to a future where more personalised, microbiome-informed care can complement existing diagnostic approaches.”

Check Warner, co-founding partner at Ada Ventures, added: “Juno Bio is setting a new standard for how vaginal health is understood and managed.

“What they’ve built at this stage, with this level of capital efficiency, is exceptional.

“We’re proud to support the team as they scale their clinical infrastructure and continue leading innovation in this critically underserved category.”

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