On May 22, 2020, OraSure Technologies announced that its OMNIgene-ORAL saliva collection device (OM-505) was included in the FDA Emergency Use Authorization granted to P23 Labs.

The P23 Labs’ TaqPath SARS-CoV-2 assay, combined with OMNIgene-ORAL (OM-505), facilitates the detection of nucleic acid from SARS-CoV-2 using oral fluid samples self-collected at-home with telemedicine support or in an assisted living setting, at a doctor’s office or at a drive through collection site.

This was the second EUA that utilizes a DNA Genotek collection device. Earlier in the month, the Company’s ORAcollect®·RNA kit (OR-100) was included as the collection device for anterior nares (nasal) samples EUA granted to Biocerna LLC for its PCR-based SARS-CoV-2 assay.