Breakthrough Immunoassays to Aid in Risk Assessment of Preeclampsia

Preeclampsia, a critical complication during pregnancy, is a life-threatening hypertension condition that can arise during pregnancy and continue into the postpartum period. As the chief cause of maternal and fetal deaths and health issues globally, preeclampsia has seen a marked increase in incidence rates within the United States over the past ten years.

Now, the first and only immunoassays for the risk assessment and clinical management of preeclampsia have received breakthrough designation and clearance.

Thermo Fisher Scientific (Waltham, MA, USA) has received the U.S. Food and Drug Administration (FDA) clearance for its B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel biomarkers. These groundbreaking assays are intended for use in conjunction with other lab tests and clinical evaluations to assist in assessing the risk of pregnant women admitted for hypertensive pregnancy disorders, and determining their likelihood of developing severe preeclampsia features within the subsequent two weeks.

Testing of the blood-based biomarkers, B·R·A·H·M·S sFlt-1 KRYPTOR and B·R·A·H·M·S PlGF plus KRYPTOR, aids in identifying the onset of severe preeclampsia, as corroborated by the PRAECIS study. The study encompassed 18 U.S. hospitals and over 700 pregnant women nationwide. Women with a positive test result, determined by the risk stratification ratio of the two assays (sFlt-1/PlGF ratio ≥ 40), could benefit from increased monitoring and expedited care before the emergence of severe features. These novel assays have been designed for operation on the Thermo Scientific B•R•A•H•M•S KRYPTOR compact PLUS clinical chemistry analyzer. Utilizing TRACE technology, based on Nobel Prize-winning chemistry, the analyzer can yield results in under 30 minutes.

“Thermo Fisher is committed to advancing diagnostic solutions for reproductive health as part of our broader Mission to enable our customers to make the world healthier, cleaner, and safer,” said Alan Sachs, chief medical officer at Thermo Fisher Scientific. “Today’s clearance of these breakthrough biomarkers will have a significant impact on prognosis and treatment for thousands of women at risk for preeclampsia every year in the U.S.”