in ,

OraSure Gains BARDA Backing for First Rapid COVID-19 Home Testing Kit

BARDA and OraSure Technology, Inc. are working together on the development of a point-of-care (POC) test for SARS-CoV-2 that could bring testing closer to the patient. OraSure’s rapid, point-of-care test will be available for use both in clinical settings and at home. This test could become the first for use at home in the United States.

OraSure today announced it has been awarded a $710,310 contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS), to develop a pan-SARS-coronavirus antigen rapid in-home self-test that uses oral fluid samples.  This support from BARDA will enable OraSure to file for FDA Emergency Use Authorization (EUA) allowing for an in-home self-test to debut into the U.S. market.

OraSure’s portable rapid test platform uses an oral fluid sample and provides results in 20 minutes.  No instrumentation or trained personnel would be needed to administer the test or to read the results. OraSure has a well-documented history of success with in-home infectious disease testing; the Company’s oral fluid self-test for HIV has been used to diagnose millions of people around the world and connect them to life-saving care.

Once developed and the necessary approvals are obtained, an in-home self-test for COVID-19 would help alleviate the pressure on over-burdened healthcare systems. 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. This would help maintain social distancing and curb the spread of novel coronavirus through symptomatic and asymptomatic transmission. Rapid in-home testing could also ease the burden on lab-based testing.

Most current coronavirus tests require a nasopharyngeal or oropharyngeal sample, which can be painful to collect and difficult to attain through self-sampling. An effective test based on an oral sample that can be used in home would enable an easier and pain-free sample collection, as well as much wider access to testing.

A rapid antigen test would also aid in screening initiatives to identify individuals with acute COVID-19 infection with or without symptoms, allowing immediate follow-up access to the patient for further testing and/or quarantine and treatment if necessary.

Test results are available to the user in approximately 20 minutes.

FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available

UK Launches Wide-Area Biosensor Competition