Ariosa Diagnostics Secures New York Lab Licensure Approval for the Harmony™ Prenatal Test

Feb 12, 2014, 09:02 ET from Ariosa Diagnostics

SAN JOSE, Calif., Feb. 12, 2014 /PRNewswire/ -- Ariosa Diagnostics, Inc., maker of the Harmony™ Prenatal Test has received approval from the New York Department of Health, Division of Laboratory Quality Certification, to offer, market and report results of the Harmony test to healthcare providers in the State of New York. According to state statistics from 2011, New York reported over 362,000 pregnancies, underscoring the significant number of potential patients in New York who may benefit from the Harmony Prenatal Test.


The laboratory quality standards required by the State of New York are seen as one of the most rigorous in the nation. Commenting on the approval, Ken Song, MD CEO of Ariosa Diagnostics stated "We are pleased to be able to make available the Harmony Prenatal Test to patients and their health care providers in New York State."

The Harmony test is a blood test for pregnant women that can be used as early as 10 weeks in pregnancy.  By evaluating cell-free DNA from the fetus found in maternal circulation, the test can assess the risk of Down syndrome with greater than 99% accuracy.  Compared to traditional prenatal screening tests, the Harmony test with its much higher accuracy represents a significant advance in prenatal testing. 

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. Our Harmony Prenatal Test is a safe, non-invasive and highly accurate blood test for pregnant women that can assess, with a high degree of accuracy, the risk of the most prevalent fetal chromosome conditions, such as Down syndrome. Led by an experienced team, we believe our approach is fundamentally transforming complex molecular testing into an affordable solution that meets the rapidly evolving needs of patients, providers and payers.

The company was incorporated in 2008 and is headquartered in San Jose, Calif. For more information, visit Follow us on Twitter @HarmonyPrenatal and on Facebook at Harmony Prenatal for Healthy Pregnancy.

Jen Bruursema

SOURCE Ariosa Diagnostics