On May 19, 2023, the FDA cleared a novel biomarker serum test for the risk stratification for severe preeclampsia in hypertensive pregnant women. This clearance is the first given to any blood-based biomarker test for assessing preeclampsia risk. The company is Thermo Fisher Scientific (no disclosures). But what does this test actually check for? Who qualifies for this? And what was the clinical investigation that the FDA based its clearance decision on? And most importantly…what do we do with this result?! We will answer all of these questions- the what, why, how, and what now- in this episode.
Dr. Chapa’s Clinical Pearls.