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New York Certifies Verinata's Lab, Paving Way for Firm to Offer Verifi NIPD in All 50 States

NEW YORK (GenomeWeb News) – Illumina announced late Thursday that Verinata Health has received a clinical laboratory permit from the State of New York for its laboratory, allowing the company to market its Verifi non-invasive prenatal diagnostic test in the state.

As a result, the test for trisomy 21, 18, and 13 and sex chromosome abnormalities can be offered by Verinata in all 50 states. Illumina, which purchased Verinata in February, noted that Verinata's laboratory is CLIA certified and CAP accredited.

During Illumina's recent second-quarter conference call, President and CEO Jay Flatley said that it plans to obtain clearance from the US Food and Drug Administration to sell Verifi as an in vitro diagnostic test and has begun discussions with the agency on a trial design.