September 4, 2020 – OraSure Technologies, Inc. (Bethlehem, PA) announced that its ORAcollect·RNA (OR-100) collection device was included along with other devices in the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) granted to MiraDx Inc. (Los Angeles, CA), a molecular genetics company. This is the fifth EUA to include a collection device from the company’s DNA Genotek subsidiary.
MiraDx will utilize ORAcollect·RNA to collect oropharyngeal samples in its COVID-19 testing program for essential workers and first responders. Samples are collected under the supervision of a healthcare professional.
MiraDx is performing COVID-19 PCR-based viral detection testing in their CLIA-certified, high-complexity molecular diagnostics laboratory that can provide 24-48 hour turnaround time. The MiraDx SARS-CoV-2 assay, combined with ORAcollect·RNA, facilitates the detection of nucleic acid from SARS-CoV-2 using highly sensitive quantitative PCR technology.