On Jun. 8, 2020, OraSure Technologies announced that Phosphorus Diagnostics, a leader in diagnostic and bioinformatic solutions for clinical next generation sequencing (NGS), was granted an Emergency Use Authorization (EUA) by the the U.S. Food and Drug Administration (FDA) allowing individuals to self-collect saliva specimens with the Companyﾒs Oragene-Dx (OGD-510) collection kit for the detection of SARS-CoV-2 using the Phosphorus COVID-19 RT-qPCR test.

The Phosphorus COVID-19 RT-qPCR test detects nucleic acid from SARS-CoV-2 in the saliva of individuals who are suspected of being infected with COVID-19 by a healthcare professional. Combined with the easy-to-use Oragene^® Dx (OGD-510) saliva collection device from OraSure’s subsidiary, DNA Genotek, this is an easily deployable testing option for patient or employee populations and for at-home use. Eligibility to receive an Oragene^® Dx collection device for in-home self-collection will be determined based on a medical questionnaire reviewed by a healthcare professional before shipment.

This is the third EUA for SARS-CoV-2 testing that utilizes a DNA Genotek collection device and the first that allows a fully at-home, unsupervised collection solution utilizing a DNA Genotek device. Earlier this month, the Company’s ORAcollect^® RNA kit (OR-100) was included as the collection device for the EUA granted to Biocerna LLC. The Company’s OMNIgene^® ORAL (OM-505) was included in the EUA recently granted to P23 Labs.