On May 4, 2020, DNA Genotek, a subsidiary of OraSure Technologies, announced that its ORAcollect RNA kit (OR-100) was included as the collection device for anterior nares (nasal) samples under a FDA Emergency Use Authorization granted to Biocerna for its PCR-based SARS-CoV-2 assay.

The Biocerna assay, combined with the ORAcollect®·RNA collection kit, is designed to allow for self-collection of nasal samples for the purpose of detecting the SARS-CoV-2 genome using the ThermoFisher Scientific TaqPath COVID-19 Combo Kit under the supervision of a healthcare provider. ORAcollect®·RNA is an all-in-one system for the collection, stabilization and transportation of human, microbial and viral RNA.

OraSure Technologies, DNA Genotek’s parent company, is developing a pan-SARS-coronavirus antigen rapid in-home self-test that uses oral fluid samples, and a lab-based oral fluid microplate coronavirus antibody enzyme-linked immunosorbent assay (ELISA). “We are proud to bring our experience with sample collection and infectious disease diagnostics to bear in the battle against COVID-19. Improving and increasing the capacity of COVID-19 testing is crucial to controlling the pandemic and restarting the global economy,” said Stephen S. Tang, Ph.D., President and CEO of OraSure.