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New York State Approves Counsyl's Noninvasive Prenatal Screen

NEW YORK (GenomeWeb) – The New York State Department of Health has approved Counsyl's noninvasive prenatal screen, Prelude, which can be run as early as 10 weeks into gestation to determine the risk of fetal chromosomal aneuploidies that can cause Down syndrome and other conditions, the company announced today.

The South San Francisco, California-based genetic testing firm uses next-generation sequencing to analyze circulating cell-free DNA in maternal blood, as well as custom algorithms and bioinformatics tools.

"We are thrilled the state’s medical authority is confident in our technology, which helps us continue our commitment to raising awareness about the importance of genetic screening before and during pregnancy," James Goldberg, chief medical officer at Counsyl, said in a statement.

Most states allow testing firms to offer certain tests after they have received CLIA certification, but New York State has its own set of requirements in order for companies to offer laboratory-developed tests there. A number of other firms have also received approval for NIPT testing in New York, including Natera, Illumina's Verinata Health, and Roche.