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Roche Obtains CE Mark for Harmony Noninvasive Prenatal Test

NEW YORK (GenomeWeb) – Roche said today that its Harmony Prenatal Test, a noninvasive prenatal test for fetal trisomy 21 and other chromosomal disorders that uses cell-free DNA from maternal blood, has received the CE mark.

Harmony was initially launched in 2012 as a laboratory-developed test by Ariosa Diagnostics, which Roche acquired for up to $625 million in late 2014. The test assesses the probability of fetal trisomy 21, 18, 13 and sex chromosome aneuploidy. The original assay ran on a next-generation sequencing platform but was later moved to a microarray platform.

Roche said it will offer the microarray-based Harmony IVD kit and Ariosa Cell-Free DNA System (AcfS) software to laboratories outside the US in response to the growing demand for local NIPT, adding that the kit will be available for shipping at the end of 2016.