ARTICLE | Clinical News

Harmony Prenatal Test regulatory update

October 24, 2016 7:00 AM UTC

Roche received CE Mark approval for the second-generation Harmony Prenatal Test to screen for Down syndrome and other chromosomal disorders. The test is a non-invasive prenatal multiplex assay that detects fetal trisomies 13, 18 and 21 in maternal plasma cell-free DNA (cfDNA). It runs on the microarray-based Ariosa cell-free DNA System. The company said the approval enables labs to perform local in vitro diagnostic testing in countries that accept CE Mark...