NEW YORK (GenomeWeb) – Roche's Ariosa Diagnostics has received the CE mark for its proprietary FORTE software that is part of its noninvasive Harmony Prenatal Test and has licensed the test technology to several laboratories.
"Achieving this regulatory milestone validates our efforts and allows Ariosa to partner with labs throughout Europe and license the FORTE software required for technology transfers," said Ariosa Chief Operating Officer Dave Mullarkey in a statement.
The FORTE software will reside on a server at laboratories licensing it to allow for processing of patient data in the country of testing.
Separately, Ariosa said it has licensed the Harmony test technology to several laboratories, and that a "first wave" of labs in Europe will conduct the test. Ariosa continues to pursue CE-IVD certification for the Harmony test.
German startup Cenata is the first laboratory offering the test.