OraSure Subsidiary DNA Genotek’s OMNIgene·ORAL Included in EUA Granted to Ambry Genetics for Use in COVID-19 RT-PCR Saliva Test

This is the Eighth EUA to Include a Self-Collection Device from DNA Genotek

BETHLEHEM, Pa., Jan. 29, 2021 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (NASDAQ: OSUR), a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, today announced its OMNIgene·ORAL (OM-505) saliva collection kit, a product of subsidiary DNA Genotek, was included in the Emergency Use Authorization (EUA) granted to Ambry Genetics for use in its Ambry COVID-19 RT-PCR saliva test. OMNIgene·ORAL will be utilized for non-invasive and self-administered collection and stabilization of saliva for the detection and identification SARS CoV-2 RNA. This is the eighth EUA to include a collection device from the Company’s DNA Genotek subsidiary.

Ambry Genetics will utilize OMNIgene·ORAL with the test authorized by this EUA to provide COVID-19 viral infection testing for population screening and back to work programs, as well as for sample collection in healthcare settings. The use of the OMNIgene·ORAL collection device allows the sample to be collected unsupervised at home by individuals, or in the clinic by healthcare professionals, minimizing risk and exposure to infected individuals.

“We are proud to have our self-collection devices included in eight viral RNA tests that have received EUAs from the United States Food and Drug Administration (FDA),” said Kathleen Weber, Executive Vice-President, Business Unit Leader, Molecular Solutions at DNA Genotek. “The authorization of our devices in multiple tests for use at-home or in clinics not only provides increased patient access to tests, but also protects others from potential exposure. We are thrilled to help Ambry Genetics deliver convenient, safe, and accurate testing as part of their CARE for COVID platform.”

About OraSure Technologies

OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. OraSure, together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.