Roche’s Ariosa Diagnostics has announced CE Mark approval for its Forte software, which will support continued expansion of the firm’s Harmony prenatal test in Europe and worldwide.
Forte software is used for analysis of cell-free DNA (cfDNA) isolated from plasma of a pregnant woman, in a bid to evaluate the risk of foetal chromosome 21, 18, and 13 trisomy, as well as foetal chromosome X and Y aneuploidy and foetal sex.
Combined with other clinical indicators and risk factors, the software is capable of providing a more accurate assessment of foetal chromosome conditions than other statistical methods.
Ariosa chief operating officer 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 company intends to reside the software on a server at licensed labs to enable processing of patient data in the country of testing.
In a separate development, the company also granted licenses to laboratories to develop, validate and conduct non-invasive prenatal testing (NIPT) using its Harmony prenatal test technology in their own labs.
Features of the Harmony prenatal test technology include rapid turnaround time, foetal fraction measurement and reporting, scalability, as well as individualised patient risk score.
Ariosa Diagnostics CEO Ken Song said: "They represent a significant step in reaching our goal to offer the broadest access to the world’s leading and most validated NIPT to pregnant women worldwide."