In Brief: Biex SalEst test
This article was originally published in The Gray Sheet
Executive Summary
Biex SalEst test: FDA grants expedited review to a premarket approval application submitted in July for the test system, which is intended to identify women at risk for preterm labor and delivery, the firm states. The test is designed to predict the risk of preterm delivery via measurement of salivary estriol (E3), an estrogen hormone produced by the placenta and the fetoplacental unit after the ninth week of gestation ("The Gray Sheet" Sept. 16, 1996, I&W-7)...