Ariosa公司：无创产前诊断项目获得美国纽约州正式许可

2月12日，美国纽约州正式授予Ariosa诊断公司无创产前诊断许可证。Ariosa诊断公司（http://www.ariosadx.com）已为15万妇女做了无创产前诊断（其商业服务品牌为Harmony Prenatal Test，）。所用的方法也同样是采孕妇的外周静脉血，并抽提血浆中的游离DNA，通过高通量测序来检测胎儿的染色体异常增多症。现在Ariosa诊断公司拿到的政府的许可，可以不受限制地在全美国50个州开展无创产前诊断服务。

“我们很高兴获得这一许可，可以合法地为孕妇提供产前无创检测”Ariosa公司CEO，医学博士Ken Song说。

中国政府相关部分也在加速这一进程，已经为该项目设立了绿色通道，预计很快就会有一批公司获得许可。

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Ariosa Obtains Licensure Approval from New York for Harmony NIPT
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.、

来源：转化医学网