OSUR: Saliva-based At-Home Collection for 6th Company Sept 24, 2020 12:57:35 GMT
Post by icemandios on Sept 24, 2020 12:57:35 GMT
OraSure’s ORAcollect®·RNA Device Included in EUA Granted to Quadrant Biosciences Inc. for COVID-19 Test
BETHLEHEM, Pa., Sept. 24, 2020 (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 that its ORAcollect®·RNA (OR-100) saliva collection device has been included in the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) granted to Quadrant Biosciences Inc. for a COVID-19 laboratory test. Under the EUA, the ORAcollect®·RNA (OR-100) device can be used to collect saliva samples from individuals suspected of COVID-19 infection by a healthcare professional. This is the sixth EUA to include a collection device from the Company’s DNA Genotek subsidiary and the first to exclusively utilize a saliva collection method.
Quadrant’s Clarifi COVID-19 Test Kit, developed in partnership with SUNY Upstate Medical University, leverages the company’s established expertise in RNA-based diagnostics. The non-invasive, and easy to administer, saliva swab test determines the presence or absence of SARS-CoV-2 viral RNA, and will be immediately available for use by high-complexity clinical laboratories serving patients through physicians' offices, urgent care clinics and hospitals.
“Expansion of testing is a key to helping slow the spread of COVID-19 and safely reopen economies. That’s why DNA Genotek is leveraging our expertise in non-invasive sample collection to provide more devices to more testing facilities, to help check millions of people around the world for COVID-19,” said Kathleen Weber, Executive Vice President, Business Unit Leader, Molecular Solutions at DNA Genotek. “DNA Genotek, now with six EUAs that include our collection kits, has emerged as a leading company helping to detect the virus.”
“We are thrilled that the FDA has issued the Clarifi COVID-19 test EUA approval for use in the diagnosis of COVID-19,” said Richard Uhlig, Founder and CEO of Quadrant Biosciences. “The coronavirus has had a devastating effect on health and welfare worldwide, so it is extremely gratifying for us to take the expertise we have gained working on RNA diagnostic tests for other health conditions, such as autism spectrum disorder and Parkinson's disease, and apply that expertise to the development of this critically important test.”
About OraSure Technologies
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. For more information on OraSure Technologies, please visit www.orasure.com .
About DNA Genotek
DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., focuses on providing high-quality biological sample collection products and end-to-end services for human genomics and microbiome applications. The Company's Oragene®•Dx and ORAcollect®•Dx product lines are the first and only FDA 510(k) cleared saliva-based DNA collection devices for in vitro diagnostic use. DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from multiple sample types. DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries. For more information about DNA Genotek, visit www.dnagenotek.com