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Ariosa Obtains Licensure Approval from New York for Harmony NIPT

NEW YORK (GenomeWeb News) – The New York Department of Health has approved Ariosa Diagnostics to offer its non-invasive prenatal test to state residents, the company said today.

The Harmony Prenatal Test is performed at Ariosa's CLIA-certified clinical laboratory. New York, however, requires firms offering certain tests to also obtain state approval in order to offer those tests to its residents.

A handful of other states also require state approval in addition to CLIA certification for laboratory-developed tests, such as Harmony, before they can be made available. An Ariosa spokesperson told GenomeWeb Daily News in an e-mail that the company can now offer the Harmony test "in all 50 states without restriction. The laboratory is approved in each state that does require licensure and no approvals are pending."

Citing state statistics, Ariosa said that in 2011 there were more than 362,000 pregnancies in New York.

Harmony evaluates cell-free DNA from the fetus found in maternal circulation to assess the risk of fetal aneuplodies, including trisomy 21, 18, and 13. Since its launch in May 2012 through September 2013, Ariosa has performed the test on more than 150,000 women, Clinical Sequencing News reported recently.