January 21, 2012 – OraSure Technologies, Inc. (Bethlehem, PA) announced that its Oragene•Dx (OGD-610) saliva collection device was included as a component in the De Novo authorization granted by the U.S. Food & Drug Administration (FDA) to Helix for its Helix Laboratory Platform, a whole exome sequencing platform.
This is the first exome sequencing-based platform authorized by the FDA. Oragene•Dx is a product of OraSure’s DNA Genotek subsidiary.
Oragene•Dx (OGD-610) was also included as a component in the 510(k) clearance Helix received for its Helix Genetic Health Risk App for late-onset Alzheimer’s Disease for over-the-counter use – the first test to be cleared on the Helix Laboratory Platform.
This FDA Authorization makes it possible for Helix and its partners to develop and obtain market authorization for future tests using subsets of sequencing data generated from the Helix Laboratory Platform, including for cancer, cardiovascular disease, and carrier screening.