NEW YORK (GenomeWeb) – DNA Genotek announced today that it has received 501(k) clearance from the US Food and Drug Administration for its sample collection device, an alternative to buccal swabs that enables makers of molecular diagnostic devices and laboratory developed tests to reduce the time and regulatory burden associated with their FDA submissions.
The device, the ORAcollectDx, is part of DNA Genotek's OrageneDx saliva-based DNA collection and stabilization devices.
DNA Genotek, which is a wholly owned subsidiary of OraSure Technologies, said the ORAcollectDx collection device consists of a liquid-based sample that improves lab efficiency, and that it eliminates manual steps such as cutting tips, reducing the probability of errors and cross-contamination. According to the firm, the device provides higher DNA yields than buccal swabs, reduces bacterial contamination, and is stable for months at ambient temperatures.
ORAcollectDx is complementary to the company's OrageneDx, which received FDA 501(k) clearance in 2011. In the same year, the Oragene DNA collection product was selected by the International Collaboration on ADHD and Substance Abuse study, conducted in the US, Australia, and eight European countries.
"Our robust portfolio of FDA-cleared products offers our diagnostic customers in the US a broad range of options for DNA collection for tests requiring both low and high amounts of high-quality DNA," Brian Smith, general manager, genomics and microbiome at DNA Genotek, said in a statement. "ORAcollectDx fills a critical need for a cleared device that improves on the stability and yield of buccal swabs while offering a liquid sample."
ORAcollectDx is FDA cleared for in vitro diagnostic use with Genmark Diagnostics' PCR-based eSensor Warfarin Sensitivity Saliva Test.