Oct. 3, 2016—Roche announced that its Harmony Prenatal Test for assessing the probability of Down syndrome and other chromosomal disorders has received the CE mark. Initially introduced in 2012 as a send-out test designed to assess the probability of fetal trisomy 21, 18, 13, and sex chromosome aneuploidy, the second-generation Harmony Prenatal Test has improved performance while reducing costs and processing time. Roche now offers the micro-array based Harmony IVD kit and Ariosa Cell-Free DNA System software to laboratories outside the U.S. in response to the growing demand for local noninvasive prenatal testing.
The CE-IVD Harmony Prenatal Test is a noninvasive prenatal test for pregnant women, based on cell-free DNA analysis. This blood screening test can be used as early as 10 weeks into pregnancy. The results are intended for prenatal screening and are not intended to be the sole basis for diagnosis. The Harmony IVD kit will be available for shipping by the end of 2016.