Mirvie Inc. continues the development of precision medicine for pregnancy-related conditions with its Encompass blood test to predict preeclampsia risk and individualized support to head off the life-threatening complication that affects one in 12 pregnancies. The test, which received U.S. FDA breakthrough device designation in 2022, is now available to order online with clinician review via telehealth.
With rates of preeclampsia skyrocketing, the U.S. FDA’s510(k) clearance of Roche Holding AG’s Elecsys test for preeclampsia offers some hope of reducing the number of women and infants who die or experience life-long consequences from the development of dangerously high blood pressure during late pregnancy and in the days immediately following delivery.
Omini SA hopes that the multiplexed blood testing platform it is developing will transform the lives of patients suffering from heart failure. With its multiplex, sensor-based testing strip that simultaneously measures four key biomarkers from a single drop of blood, the company’s technology should increase the chance of a patient’s survival and reduce pressure on health care systems, Joanne Kanaan, CEO and co-founder of Omini, told BioWorld.