On Jul. 31, 2020, OraSure Technologies announced that its OMNIgene-ORAL (OM-505) saliva collection device is included in the FDA Emergency Use Authorization (EUA) granted to Clinical Reference Laboratory, one of the largest privately held clinical testing laboratories in the U.S. for SARS-CoV-2 testing. This is the fourth EUA to include a collection device manufactured and sold by the Company’s DNA Genotek subsidiary.

The EUA authorizes CRL to use the OMNIgene®·ORAL device with CRL Rapid Response™, its saliva-based SARS-CoV-2 RT-PCR test that can be self-collected at home, work or any other setting, when COVID-19 infection is suspected by a healthcare provider. The saliva sample would be collected with the OMNIgene·ORAL (OM-505) saliva collection device, which is specifically designed for self-collection, stabilization, storage and shipment of samples to the laboratory. The OMNIgene·ORAL device offers improvements over the standard nasopharyngeal swab because virtually anyone can collect a saliva sample at home with no discomfort and return it to the lab for processing, allowing personnel and protective equipment to be saved for when they are most needed.

OraSure Technologies empowers the global community to improve health and wellness by providing access to accurate, essential information. Together with its wholly-owned subsidiaries, DNA Genotek, Diversigen, CoreBiome (now operating under the Diversigen brand), UrSure and Novosanis, OraSure 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.