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OraSure Subsidiary DNA Genotek Announces FDA General Use Clearance For Oragene·Dx Family Of Products

OTTAWA, Jan. 22, 2020 (GLOBE NEWSWIRE) -- DNA Genotek Inc., a leading provider of sample collection kits and end-to-end services and a wholly-owned subsidiary of OraSure Technologies, Inc. (NASDAQ:OSUR), announced today

Benzinga · 01/22/2020 11:04

OTTAWA, Jan. 22, 2020 (GLOBE NEWSWIRE) -- DNA Genotek Inc., a leading provider of sample collection kits and end-to-end services and a wholly-owned subsidiary of OraSure Technologies, Inc. (NASDAQ:OSUR), announced today that the U.S. Food and Drug Administration (FDA) has granted a general use 510(k) clearance for its Oragene®•Dx family of products.
 

Oragene®•Dx is intended for use in the non-invasive collection of saliva samples for in vitro diagnostic testing of human DNA. Oragene®•Dx is now the first and only device with general clearance for collection and stabilization of DNA from saliva for use in genetic testing of human germline DNA, including prescription or over-the-counter (direct-to-consumer) use. Saliva samples collected using Oragene®•Dx are stabilized for use in downstream diagnostic testing applications and can be transported and/or stored long-term at ambient temperatures.