On Sept. 3, 2020, OraSure Technologies announced that its ORAcollect-ﾷRNA (OR-100) collection device was included along with other devices in the FDA Emergency Use Authorization (EUA) granted to MiraDx, a Los Angeles-based 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 their COVID-19 testing program for essential workers and first responders to help slow, and hopefully prevent, the spread of COVID-19. 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.