Despite the ongoing maternal health crisis in the United States, there is hope for pregnancy health on the horizon. Thanks to the power of precision medicine, a new era of pregnancy health is rapidly evolving and becoming a reality. By applying the latest scientific approaches from precision medicine to pregnancy, we can improve the health of expectant mothers and their babies. Leading the way in creating this new era is the Mirvie RNA platform, which can decipher the intricate biology of pregnancy and predict potential complications months before symptoms.
Recently, Mirvie CEO and Co-Founder Maneesh Jain sat down with one of Mirvie’s investors, Holly Maloney, Managing Director at General Catalyst, to discuss how better diagnostics can enable biology-driven and preventative care that can leapfrog pregnancy care into the 21st century.
During their discussion, Maneesh and Holly highlighted the urgent need for widespread and systematic change in pregnancy health. They shared how their personal experiences ignited a sense of urgency to chart a new course for pregnancy health.
How did your personal experiences help you understand how pregnancy care had to change?
Holly: I actually referred to pregnancy as a black box. I had a clean bill of health my whole life. I had two really healthy early pregnancies with both of my daughters, however, both ended in stressful deliveries. Just highlighting my second, I had a placenta abruption a month before my due date. Because I had been viewed as healthy so far in my pregnancy journey, I was completely uninformed as to what was happening. The doctors still don't know why it happened. So there clearly hasn't been enough research conducted such that my situation could be understood to know what caused this outcome. This really impacts me the most in my decision-making as to whether I have more children. Suppose there were some kind of precision healthcare plan to guide me through a future pregnancy. In that case, I'd be much more open-minded to considering having another child, knowing that if I were at risk, if there were some sort of tailored medical or procedural care plan that could result in a healthy mom and baby, that would be incredibly enlightening and comforting for me.
Maneesh: My personal experience with our first child was eye-opening. We went in expecting a routine delivery with induction, and then 36 hours later, it’s just chaos - an emergency C-section and with very little information about a baby in distress. I just remember this feeling of utter helplessness, knowing so little about something that matters so much. We've heard many moms describe pregnancy like a black box. Mirvie’s co-founder Stephen Quake also had a profound experience. Everything was totally routine and normal in the pregnancy, and then several weeks before the due date, they rushed to the ER for a preterm baby. I was shocked to learn that complications strike 1 in 5 pregnancies, often without warning.
If families like ours knew their risk for complications months earlier in pregnancy, we’d have the opportunity for earlier and more effective interventions to prevent or prepare for them. In oncology, cardiology, and infectious diseases, these principles of precision medicine are quickly becoming the rule, not the exception. Why should pregnancy health be any different? It became clear to Dr. Quake and me that the Mirvie RNA platform could spark a revolution that could pave the way for a fundamentally different pregnancy care ecosystem, one that meets the expectations of the 21st century.
Why is pregnancy health the next frontier in precision medicine?
Maneesh: Each week delivers fresh headlines that remind us of the critical state of maternal health in the United States. It's a heartbreaking narrative and a stark contrast against the backdrop of what The New York Times recently coined as a "Golden Age for Medicine," characterized by astonishing innovation, pushing limits and the boundaries of imagination. But amid this wave revolutionizing many medical fields, the potential of precision medicine in pregnancy has remained untapped. But now, with the introduction of the Mirvie RNA Platform, a profound shift is on the horizon. This groundbreaking platform can predict pregnancy complications months before symptoms manifest, a monumental leap forward that opens the door to a sweeping, head-on reimagining of pregnancy care that personalizes treatment based on the unique needs of the biology of that pregnancy.
Did your experience make you second guess whether you were doing everything you could to have the healthiest pregnancy possible?
Holly: I've rethought every single step of the way. I've thought maybe I shouldn't have done that one extra Peloton ride, or maybe that hike that I went on a couple weeks prior was too strenuous, or was I sleeping enough? I had another baby at the time. Was I carrying that baby more than I should have? But of course, then there are implications of not doing that. There are so many question marks and no answers, which is frustrating. I think there are greater rippling implications from a mental health perspective. If you have shock and trauma, what are the other things that are happening in your body that may negatively affect the pregnancy in real time? Then also, what are the longer-term effects of going through that kind of trauma? When you look at pregnancy health at a systems level and through the lens of precision medicine, you start to see so many opportunities to tailor care to suit the distinctive needs of each family and the unique biology of every pregnancy.
What do you see as the priorities in women’s health and pregnancy health?
Holly: Women’s health was so under-resourced and under-researched for a really long time. I think the first law requiring women to be included in clinical research wasn't even passed until 1993, which is shocking. But I think people are finally waking up to the fact that, yes, women make up roughly half the population, but they also manage approximately 80% of healthcare spending. Creating opportunities for funding and innovation for women's health is really the entry point into broader family health. While there's absolutely a ton of innovation that will occur around fertility and pregnancy, menopause is the next high-cost event in a woman's life. The need for continuous care, higher engagement and an increase in education for women about how and when they can access our healthcare system before it's an emergency is going to benefit our system longer term.
Maneesh: If we can reduce the number of high-risk pregnancies in the U.S. annually, we are much more likely to have better outcomes, not just for mom and baby at the time of birth, but also over their lifespans. Pregnancy health has a compounding effect on our healthcare system from a cost perspective. Sometimes we treat events as individual events and episodes, but what happens in pregnancy can have an impact far downstream. So if you have preeclampsia, then there's a much higher lifetime risk of cardiovascular disease and stroke, and these things for a long time have been treated completely separately.
What areas of women’s health can we advance that have been left behind over the decades?
Holly: Very few people understand the maternal health crisis in our country. Anytime I tell somebody the stat that you're better off having a baby in 40-plus other countries than you are here in the U.S., they are shocked. And if you were to look at the Black Medicaid population, it's just abysmal. I think our country did a decent job in elevating the awareness of the mental health crisis holistically since Covid. We need a similar ringing of the bell about the crisis related to maternal health outcomes in our country to create a sense of urgency and priority from an investment perspective.
Among the highest priorities is figuring out how we can engage under-resourced moms. In some states, moms are enrolling in Medicaid during their second trimester. If that's when people are only starting to engage in the process of their pregnancy journeys, it's sort of too late to impact the outcomes. Figuring out how to bring moms into our healthcare system early regardless of the resources they have is critical.
Maneesh: There's definitely the sense that we need to leapfrog decades of stasis. So because it's been decades behind, we can't take decades to make a difference. It has to be an approach that could leapfrog within a few years. Whether it's advances in genomics or AI, machine learning, or just even borrowing from fields that have advanced further, like cardiology, oncology or infectious disease, bringing those things over to pregnancy health will create tremendous opportunity. It's not just a pregnancy issue or women's issue, but it's really a family health issue.
Why is the Mirvie RNA platform a breakthrough, and what are the next steps to bring it to market?
Maneesh: Pregnancy complications can happen to anyone, often with no warning – from the fittest athletes to your own colleagues, friends and family. Many complications, including preeclampsia, are much more likely to be prevented if the underlying disease biology is detected early enough. The Mirvie RNA platform’s breakthrough approach for predicting complications months in advance will be able to give families a solid path to create the healthiest pregnancy possible. Recent landmark research shows the Mirvie RNA platform can predict preeclampsia and preterm birth months in advance. For the first time, a simple blood test from mom will provide expecting parents with an understanding of the underlying biology of their individual pregnancy and risk of complications.
We’re currently enrolling over 10,000 women in a landmark pregnancy study to build the only comprehensive pregnancy complication dataset of its kind. Before bringing a test to market, it's our top priority to ensure we've developed the test in a large diverse U.S. population, to mirror the population we will soon serve so it works for all women.
