NEW YORK – DNA Genotek, a wholly owned subsidiary of OraSure Technologies, said on Wednesday it has obtained 510(k) clearance from the US Food and Drug Administration for its Oragene Dx sample collection kits.
The Oragene Dx kits are used for the collection of saliva samples for DNA testing. The company noted in a statement that 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." The kits also allow for long-term storage at room temperature of collected samples.
"With this 510(k) clearance genetic test providers offering diagnostic testing can confidently use our product within their test protocols without having to provide information on Oragene Dx devices in their FDA submissions," noted Kathleen Weber, executive vice president molecular solutions at the firm.
OraSure Technologies acquired Ottawa-based DNA Genotek in 2011 for $50.6 million.