Pregnancy complications — such as preterm labor, preeclampsia and gestational diabetes — can have serious and sometimes fatal consequences for mothers and their newborns. However, only 20% of pregnancy complications can be identified by the standard risk assessment most OB/GYNs use, according to personalized pregnancy care startup Mirvie.

Mirvie is working to solve that problem by developing diagnostic tools to help predict pregnancy risks. Founded in 2018, the company is building a RNA platform it says will be the first to predict preeclampsia and preterm labor months before they occur. 

Investors seemed to have taken notice of the value Mirvie’s platform could bring to pregnancy care — the startup raked in $60 million earlier this year and brought its total fundraising amount to $90 million.

“RNA messages reveal the underlying biology of a pregnancy,” Dr. Alison Cowan, Mirvie’s head of medical affairs, said in an interview. “So from looking at these RNA messages within our platform, we can tell really fundamental things about the pregnancy, such as what organs are forming for the baby and how far along a pregnancy is.”

The incorporation of RNA testing is a key way to personalized pregnancy care, she added. As an OB/GYN, Dr. Cowan has realized that providers “just haven’t had the tools” to effectively predict which patients will go on to have complications during their pregnancies. This is an especially dire problem because pregnancy complications are common — about one in five pregnancies is impacted by a complication of some type, Dr. Cowan said.

If OB/GYNs have the technology to determine who is at risk for complications like preeclampsia and preterm birth, they can work with patients and their midwives to create a more tailored pregnancy care plan. Personalized care plans usually lead to better health outcomes for mothers and their newborns, Dr. Cowan pointed out.

For example, if a patient gets her RNA test results back and they show that she is at an increased risk for preeclampsia, her OB/GYN can instruct her to take a baby aspirin once daily — a low-effort, low-risk move that can do a lot to protect a mother and her baby’s health if implemented early on in pregnancy. The OB/GYN may also check a patient’s blood pressure more frequently or track the baby’s growth more closely, knowing that pregnancies that are impacted by preeclampsia can also go hand in hand with having smaller babies that may need extra surveillance, Dr. Cowan said.

But Mirvie is not the only company focused on personalized prenatal care — there are others, such as Bloomlife and Oula Health. Mirvie differentiates itself from them with its focus on RNA, Dr. Cowan argued. The company believes that RNA sequencing is one of the best tools OB/GYNs can use to learn about the uniqueness of each of their patients’ pregnancies, which is why it’s working to eventually bring RNA testing to OB/GYN offices across the country.

Dr. Cowan, who joined the company in August, said she was drawn to work at Mirvie after seeing research the company published in Nature this January. She was impressed by the “thousands and thousands” of pregnant women’s RNA messages the company had analyzed. The study — which she said is the largest one ever published that looks at pregnancy RNA — showed that Mirvie’s RNA platform can identify 75% of women who go on to develop preeclampsia months before their first symptoms occur. 

The company went on to publish more research in April —its study published in the American Journal of Obstetrics and Gynecology demonstrated that the platform can accurately predict 76% of preterm birth cases, as well as flag distinct biological pathways driving this issue.

Mirvie has not provided a timeline on when the RNA tests it is developing may be available for OB/GYNs to order — the startup is currently focused on generating sound scientific evidence for its platform, Dr. Cowan said.

The test it is developing to predict preeclampsia received breakthrough device designation from the Food and Drug Administration in May.

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