Ariosa Receives Conditional Approval from New York State Department of Health for Harmony™ Prenatal Test in All Pregnant Women

May 05, 2014, 13:00 ET from Ariosa Diagnostics, Inc.

SAN JOSE, Calif., May 5, 2014 /PRNewswire/ -- Ariosa Diagnostics, Inc. today announced that it has received conditional approval from the New York State Department of Health to offer its Harmony™ non-invasive prenatal test (NIPT) in all pregnant women, regardless of age or risk.

"We are 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," said Dave Mullarkey, President and COO of Ariosa.

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.

About Ariosa Diagnostics

Ariosa Diagnostics, Inc. is a global commercial-stage molecular diagnostics company focused on improving overall patient care by developing and delivering innovative, affordable and widely-accessible genetic testing.  Led by an experienced team, we use our proprietary technology to perform a directed analysis of cell-free DNA in blood. The Harmony™ Prenatal Test equips pregnant women and their healthcare providers with reliable information to make decisions regarding their health, without creating unnecessary stress or anxiety.

The company is headquartered in San Jose, California. For more information, visit Follow us on Twitter @HarmonyPrenatal and on Facebook at Harmony Prenatal for Healthy Pregnancy.


Margaret Theeuwes, VP Marketing

Ariosa Diagnostics


Logo -

SOURCE Ariosa Diagnostics, Inc.