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

Download PDF

San Jose, Calif., February 12, 2014 – 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.