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
OraSure Technologies, a leader in point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services, 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.”
Source: Company Press Release