Scouting Report-Mirvie:Earlier Detection of Pregnancy Complications with a ML mRNA Platform

The Driver:

RNA platform company Mirvie recently raised $60 million in a Series B funding led by Decheng Capital with participation from funds managed by BlackRock, Foresite Capital, General Catalyst, GV, Khosla Ventures, Mayfield, and Olympic gold medalist Allyson Felix. Mirvie’s machine learning, messenger RNA (mRNA) platform focuses on creating precise, actionable, and non-invasive tests for maternal-fetal health. The company is currently developing a blood test designed to identify the risk of preeclampsia before symptoms occur. Mirvie announced in May that they have received FDA breakthrough device designation for their blood test. The funds acquired will be used to help fund a 10,000-person clinical trial to validate Mirvie’s technology, increasing clinical evidence as it gets closer to commercialization.

Key Takeaways:

• Around 4% of the approximately 3.6 million women who will give birth in the U.S annually will be diagnosed with preeclampsia according to Forbes.

• John Hopkins University stated the overall prevalence of preeclampsia among all women was 9.5%, with Black women having the highest age-adjusted prevalence of preeclampsia (12.4%) compared with Hispanic (8.2%) and white women (7.1%).

• The estimated total incremental costs of preeclampsia were approximately $29,000 in total (approximately $3,000 for mothers and $25,000 for infants) according to The American College of Obstetricians and Gynecologists.

• Preeclampsia encompasses 2% to 8% of pregnancy-related complications, greater than 50,000 maternal deaths, and over 500,000 fetal deaths annually worldwide according to StatPearls.

The Story:

Mirvie was founded by the CEO and Co-Founder Maneesh Jain in 2018 and a team of scientific and business pioneers that have an extensive track record innovating, developing and commercializing non-invasive and liquid biopsy tests used by millions of individuals today. After experiencing complications during their own children's births, CEO Jain and Mirvie’s scientific advisory board chair Dr. Stephen Quake both committed the rest of their professional careers to helping other parents avoid unexpected conditions during pregnancy and, hopefully, any stay in the neonatal intensive care unit. As they knew, research shows that 1 in 5 pregnancies is impacted by unexpected complications such as preeclampsia, preterm birth, and gestational diabetes, impacting more women each year than all forms of cancer. Preeclampsia affects the arteries carrying blood to the placenta and can cause the inadequate blood and oxygen flow to the fetus or even preterm birth. However, as noted by Forbes, “ the main tools to identify who’s at risk [for preeclampsia] haven’t changed in decades'' and generally include whether you have had preeclampsia before and risk factors such as : high blood pressure, weight, age, and race. With the costly consequences of pregnancy complications impacting both the mental health of the mother and physical health of the child. Mirvie aims to address these disparities through early detection with an mRNA platform study and the development of their blood test. While prior tests have attempted to look at the human genome, as noted by Forbes, Mirvie’s founders felt that exploring the RNA “could indicate whether you have a particular condition at that moment in time (or may be at risk for developing it).” In early May 2022, Mirvie’s preeclampsia test received breakthrough device designation from the FDA.

The Differentiators:

One of the main differences between Mirvie and other biotech companies is that Mirvie focuses on prenatal testing based on a blood sample and RNA sequencing. This process is non-invasive and helps identify potential complication pregnancy risks in advance. In addition, Mirvie’s tailored blood test can detect early signs of preeclampsia that are not associated with common risk factors currently reviewed, some of which would be unknown to first time mothers. Mirvie’s test is a new application of “liquid biopsy” testing, which had previously been used mostly with cancer. As noted by the American College of Pathologists, “while definitions [of the term liquid biopsy] vary, it can broadly be thought of as collection of a body fluid sample to test for relevant biomarkers to inform patient management. While the current focus is predominantly on detection of cfDNA, additional components of a liquid biopsy could include... ribonucleic acids (RNA), circulating tumor cells, extracellular vesicles or exosomes, and tumor educated platelets.”

Mirvie’s technology could potentially help reduce the racial disparity of minority women with preeclampsia and other pregnancy complications through the use of their platform. The use of preeclampsia testing in underserved communities with high minority populations could improve patient health outcomes, as well as reduce long-term healthcare costs and burden on the patients. The use of this product as a primary prevention measure may also reduce overall healthcare expenditures by helping to address any known risks in advance.

The Big Picture:

Mirvie’s goal is to predict pregnancy complications months before they occur using a simple blood test, using a combination of artificial intelligence and samples of RNA proteins in blood. In fact, in a recently published study in the American Journal of Obstetrics & Gynecology, entitled “ Predictive RNA profiles for early and very early spontaneous preterm birth”, Mirvie’s technology was able to predict three out of four preterm births an average of two months in advance of other methods, thereby helping to “identify those at risk for spontaneous preterm birth by revealing the underlying pathophysiology, creating an opportunity for more targeted therapeutics and effective interventions.” As a result, Mirvie’s solution could help change the way that OB/GYN’s assess the risk of preterm delivery, help physicians diagnose complications sooner, and relieve maternal stress during pregnancy. In addition, Mirvie’s Jain hopes that in the future their company can also predict other pregnancy issues such as gestational diabetes or placenta accreta, which can lead to severe blood loss. As the CEO noted to Forbes, “even if we can make a small impact, it'll be huge just considering it's almost approaching a million women every year in the U.S. experience these complications.”

Mirvie raises $60M to develop early preeclampsia detection and more digital health fundings; Mirvie mRNA study predicts premature births 2 months in advance; Mirvie Raises $60 Million For Blood Test To Predict Pregnancy Complications