Ariosa Diagnostics, a molecular diagnostics company of San Jose, Calif., has signed a deal with Laboratory Corporation of America Holdings (LabCorp) and Integrated Genetics, to distribute and administer its HarmonyPrenatal Test in the U.S. and Canada.
The Harmony Prenatal Test, which detects common fetal trisomies utilizing a directed approach to analyze cell-free DNA (cfDNA) in maternal blood—such as Trisomy 21, associated with Down syndrome—will be offered through LabCorp and will be available at its 1,000+ patient service centers. The test is performed using a simple maternal blood draw taken at a doctor’s office or patient service center and provides the safety of screening tests with accuracy approaching that of invasive testing for common fetal trisomies. The test is available to pregnant women of at least 10 weeks gestational age with a single fetus conceived without the use of an egg donor.
“Ariosa Diagnostics is very excited to announce the official launch of the Harmony Prenatal Test and the agreement with LabCorp, which helps us deliver on the promise of bringing an affordable and accessible prenatal testing option to pregnant women and their physicians,” said Ken Song, MD, CEO at Ariosa Diagnostics. “With enhanced test performance and simplicity, the Harmony Prenatal Test can be reliably incorporated into the management of pregnancies.”