Roche’s Ariosa Diagnostics has received CE mark approval for its Forte software, which will support the firm’s Harmony prenatal test.
The Forte software will be used to analyse cell-free DNA (cfDNA) isolated from plasma of a pregnant woman, in a bid to evaluate the risk of fetal chromosome 21, 18, and 13 trisomy, as well as fetal chromosome X and Y aneuploidy and fetal sex.
Ariosa Diagnostics COO Dave Mullarkey said: "Forte software is a cornerstone of the Harmony Prenatal Test, which has been one of the most trusted brands in NIPT among patients and OB/GYNs to determine the risk of trisomies in more than 500,000 patients in the world.
"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."
The software, along with other clinical indicators and risk factors, is said to offer a more accurate assessment of fetal chromosome conditions compared to other statistical methods.
Ariosa will reside the Forte software on a server at licensed labs to enable processing of patient data in the country of testing.
Arios, which operates from San Jose of California, was acquired by Roche in 2015.
Image: Forte software will support Ariosa’s Harmony prenatal test. Photo: courtesy of Stuart Miles/ FreeDigitalPhotos.net.