Read up on our latest news

A new blood test performed in the second trimester could help identify pregnancies at risk of early and very early spontaneous preterm birth (sPTB), based on a prospective cohort trial. The cell-free RNA (cfRNA) profiling tool could guide patient and provider decision-making, while the underlying research illuminates biological pathways that may facilitate novel interventions.

"Prenatal care as we know it in the U.S. was first developed to primarily diagnose pre-eclampsia, yet these protocols have not changed in over 50 years," said Eleni Tsigas, CEO of the Preeclampsia Foundation. "Mothers and babies deserve more – there is an urgent need for innovation that not only identifies the risk of developing pre-eclampsia early, but also helps bring pregnancy health into the 21st century."

The Mirvie Preeclampsia Test is the first test for early identification of preeclampsia risk months before any clinical presentation of symptoms to receive FDA breakthrough designation, Mirvie said. “This designation shows the FDA recognizes the chasm between what’s available to expecting parents and doctors today and the need for a breakthrough to address this enormous problem,” said Maneesh Jain, CEO and co-founder of Mirvie.

Mirvie Co-founder & CEO Maneesh Jain shares: “At Mirvie, we find it unacceptable that pregnancy health has not advanced meaningfully in decades. We believe the Mirvie RNA platform can shape a new future of predictive, preventive, and personalized pregnancy care for the well-being of millions of expecting parents and babies. We are thrilled to welcome several top-tier investors who recognize this staggering unmet need and have backed us to make a difference.”

The South San Francisco company is developing a platform to test and analyze RNA samples from pregnant people in order to detect markers from an array of complications that can occur during pregnancy. Mirvie's goal is to catch potential health conditions in the second trimester, much earlier than they are currently diagnosed which typically happens in the third trimester only after many symptoms appear.

Preeclampsia is a potentially serious problem that usually surfaces late in pregnancy, posing an immediate risk of preterm birth, stillbirth, and death as well a later danger of stroke for the mother. New research published Wednesday in Nature shows how RNA molecules sequenced from a single blood sample could predict preeclampsia months before symptoms appear, holding promise for detecting and treating this and other pregnancy complications before they cause harm.

“Early detection of preterm birth and identification of distinct pathways driving it is a fantastic advance. This new knowledge has real potential to improve the application of existing interventions and aid the development of new therapies for preterm birth that directly target its cause.”

“We see very unique RNA profiles that are associated with the development of preterm birth months ahead of time. If we’re actually able to say, I not only can identify who is at risk, I can identify the biology that makes you at risk, it just opens up this whole new world for pregnancy health and for moms.”

After being neglected for many years, adverse pregnancy outcomes such as pre-eclampsia and preterm birth are now the focus of a small group of researchers and companies that are aiming to fill a much-needed gap in the clinical testing market.

Cell-free RNA transcripts in maternal blood can be analysed to monitor the progression of pregnancy and to predict a potentially harmful pregnancy-specific condition called pre‑eclampsia.