OraSure Technologies 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.
 
Built on OraSure’s OraQuick platform, the rapid test would allow for in-home self-testing by lay users as well as by medical professionals. 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 SARS-coronavirus 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 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.
 
OraSure envisions a rapid development cycle of approximately 4-6 months prior to seeking Emergency Use Authorization (EUA).
 
“Lives and global economies are at stake. It’s crucial that we understand just how many people are infected with SARS-coronavirus,” said Stephen Tang, president and chief executive officer, OraSure. “In-home self-testing will dramatically increase the capacity for SARS-coronavirus testing and give our healthcare systems and labs some much-needed breathing room. We believe that the development of an easy-to-use device that delivers accurate results to individuals in their homes can play a significant role in impacting infection rates. We are proud to bring our expertise with quality, rapid, oral fluid self-tests to the battle against the COVID-19 pandemic.”
 
Rick Bright, director, BARDA, said, “We need to put tests into people’s hands to know their infection status and protect their loved ones. At BARDA, we are continually looking for transformative technologies to combat public health threats, and rapid at-home coronavirus testing would be a game-changer. We know that people can spread COVID-19 without showing any symptoms, and with rapid at-home testing people could take immediate action to prevent the spread of the virus.”
 
The pan-SARS-coronavirus antigen rapid in-home self-test project has been funded in whole or in part with Federal funds from the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00061.