NEW YORK – OraSure Technologies said Monday it has been awarded a $710,310 contract from Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) to develop a pan-SARS-coronavirus antigen test that uses oral fluid samples.
The firm said that the contract will support OraSure's filing for Emergency Use Authorization from the US Food and Drug Administration that would enable use of a coronavirus self-test in US homes.
OraSure’s portable rapid test platform uses an oral fluid sample and provides results in 20 minutes without an instrument.
If it receives an FDA EUA, the rapid assay ─ built on OraSure’s OraQuick antibody-based platform ─ will enable testing by lay users and medical professionals, the Bethlehem, Pennsylvania-based firm said.
An in-home self-test for SARS-coronavirus would help alleviate pressure on an overburdened healthcare system, OraSure added. Healthcare providers, retailers, and online vendors could ship tests directly to an individual’s home, eliminating unnecessary trips to hospitals, doctors’ offices, and testing facilities.
OraSure said it envisions a development cycle of approximately four to six months prior to seeking Emergency Use Authorization.