NEW YORK (GenomeWeb News) – DNA Genotek announced that its Oragene Dx collection device has become the first salivary DNA collection and stabilization device to receive 510(k) clearance from the US Food and Drug Administration.
DNA Genotek is a subsidiary of OraSure Technologies, which acquired the firm in August. Its lead product line, Oragene, provides an all-in-one system for collecting, stabilizing, and transporting DNA from saliva. FDA clearance of Oragene Dx will provide diagnostic customers the ability to offer a non-invasive alternative to blood collection as a method of gathering DNA samples.
In addition, molecular diagnostic test manufacturers will be able "to streamline their own regulatory submissions and potentially broaden market accessibility for their genetic tests," the Ottawa, Ontario firm said in a statement.
Oragene Dx can be used in FDA-cleared molecular diagnostic applications and was cleared using results from the eSensor Warfarin Sensitivity Saliva Test from GenMark Diagnostics.