September 24, 2020 – OraSure Technologies, Inc. (Bethlehem, PA) 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 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.