Benzinga | Jan 21, 2021 06:07AM EST

OraSure's Oragene Dx Saliva Collection Kit Included in Industry's First FDA Authorization for a Whole Exome Sequencing Platform

OraSure Technologies, Inc. (NASDAQ:OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced that its Oragene(r)*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 their Helix(r) Laboratory Platform1, a whole exome sequencing platform. This is the first exome sequencing-based platform authorized by the FDA. Oragene(r)*Dx is a product of OraSure's DNA Genotek subsidiary.

Oragene(r)*Dx (OGD-610) was also included as a component in the 510(k) clearance Helix received for its Helix(r) Genetic Health Risk App2 for late-onset Alzheimer's Disease for over-the-counter use -- the first test to be cleared on the Helix(r) Laboratory Platform.

"The inclusion of our Oragene(r)*Dx saliva collection device in the FDA authorization granted to Helix for the first and only whole exome sequencing platform highlights how genetic test providers offering diagnostic testing can confidently use our product within their protocols," says Kathleen Weber, Executive Vice President Molecular Solutions. "This saves time and cost for diagnostic companies that want to leverage an FDA-cleared saliva collection device into their methodologies for both supervised (i.e. prescription) and unsupervised at home collection. The team at DNA Genotek congratulates Helix on this important work."

In 2020, Oragene(r)*Dx received U.S. Food and Drug Administration (FDA) general use 510(k) clearance and remains the first and only device with general clearance for collection and stabilization of DNA from saliva for use in genetic testing, including prescription or over-the-counter (direct-to-consumer) use. Saliva samples collected using Oragene(r)*Dx are stabilized for use in downstream diagnostic testing applications and can be transported and/or stored long-term at ambient temperatures.

"Now, more than ever, it's important to offer non-invasive, at-home sample collection for clinical testing," said Marc Laurent, VP of Operations and Partnerships, Helix. "DNA Genotek's product and support were an important part of our efforts to obtain FDA authorization. We are proud to have worked with the team at DNA Genotek and to include the Oragene(r)*Dx saliva collection device in our FDA authorization."

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(r) Laboratory Platform, including for cancer, cardiovascular disease, and carrier screening.