Ariosa Diagnostics has received conditional approval from the New York State Department of Health (NYSDH) to offer its Harmony non-invasive prenatal test (NIPT) in all pregnant women, regardless of age or risk.
Ariosa president and COO Dave Mullarkey noted that the company is enthusiastic that all women in New York State, regardless of age or risk, will now have access to Harmony.
"This approval supports our mission of ensuring equality in delivery of the best medical care," Mullarkey added.
The Harmony test is a non-invasive blood test for pregnant women that can be used as early as 10 weeks into pregnancy. By evaluating cell-free DNA found in maternal circulation, the test can assess the risk of Down syndrome in the fetus with greater than 99% accuracy.
Current prenatal screening tests return false positive results as often as 5% of the time. In comparison, the Harmony test returns false positive results for Down syndrome less than 0.1% of the time, potentially lowering the frequency of unnecessary invasive procedures such as amniocentesis.
Harmony has been validated with the largest clinical data set of its kind,making it the best studied cell-free DNA based maternal blood test. The accuracy of Harmony is supported by clinical studies in more than 25,000 women of all ages and risk categories. It is available in more than 90 countries and has been used to guide clinical care in over 225,000 pregnancies worldwide.