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Ariosa's Harmony NIPT Wins NY State Approval for Use in All Pregnant Women

NEW YORK (GenomeWeb News) — Ariosa Diagnostics said yesterday that it has received conditional approval from the New York State Department of Health to offer its Harmony non-invasive prenatal test in all pregnant women, regardless of age or risk.

Ariosa had already received approval from the NYS DOH in February to offer Harmony to women with high-risk pregnancies.

Harmony 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 percent accuracy, the company said.

In addition, current prenatal screening tests return false-positive results as often as 5 percent of the time. In comparison, Ariosa noted, Harmony returns false-positive results for Down syndrome less than 0.1 percent of the time, potentially lowering the frequency of unnecessary invasive procedures such as amniocentesis.

In March Ariosa filed a regulatory document with the US Securities and Exchange Commission for an initial public offering. Last month, Illumina said that it was suing Ariosa for alleged patent infringement, claiming that Harmony's underlying technology infringes on one of its patents.