Since its inception in 2000, OraSure Technologies has been a leading innovator in diagnostic technologies. We are leveraging our expertise in infectious disease and molecular sample collection to advance three distinct COVID-19 testing solutions that feature convenient, pain-free self-collection, and help improve access to testing, alleviate the burden on the healthcare system, minimize exposure risks, and conserve PPE.
Molecular sample collection devices made by our DNA Genotek subsidiary are widely used in lab-based COVID-19 molecular tests. They have been included in multiple customer Emergency Use Authorizations (EUAs) held by a range of laboratories facilitating non-invasive collection of saliva samples for COVID-19 tests. We have also received our own FDA EUAs for the use of our OMNIgene®•ORAL and ORAcollect®•RNA collection devices in COVID-19 testing, which allow for the unsupervised use of these devices at home or in healthcare settings when used as part of an approved or validated at-home COVID-19 test kit.
OraSure has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 rapid antigen tests, which the Company is branding as InteliSwab™. The FDA has authorized the InteliSwab™ COVID-19 Rapid Test for Over-the-Counter (OTC) use without a prescription. FDA has also authorized the InteliSwab™ COVID-19 Rapid Test Pro for professional use in point of care (POC) CLIA-waived settings, and InteliSwab™ COVID-19 Rapid Test Rx for Prescription Home Use. These remarkably simple COVID-19 lateral flow tests use samples self-collected from the lower nostrils. InteliSwab’s unique design incorporates a built-in swab fully integrated into the test stick. After users swab their lower nostrils, the test stick is swirled in a pre-measured buffer solution, and the result appears right on the test stick within 30 minutes, with no instruments, batteries, smartphone or laboratory analysis needed to see the result.
OraSure is also working to secure EUA for its lab-based OraSure SARS-CoV-2 Antibody ELISA using oral fluid as a sample. Currently no COVID-19 antibody tests that use oral fluid samples have received EUA. This lab-based antibody test can aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating prior infection. Antibody tests are well suited for community surveillance and seroprevalence studies to identify people who have antibodies against COVID-19.