The U.S. federal government’s Biomedical Advanced Research and Development Authority, known as BARDA, has funded the development of a rapid coronavirus test that can be self-administered at home.
Designed by OraSure Technologies, the test would not only detect the novel infection that causes COVID-19 but all coronaviruses that can lead to severe respiratory disease, such as the strain behind the previous SARS outbreak of the early 2000s.
However, the test could still be four to six months away from being completed and ready for market, the company said. The BARDA contract awarded the company $710,310 to help OraSure eventually file for an emergency product authorization from the FDA.
“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,” OraSure President and CEO Stephen Tang said in a statement. “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.”
Compared to other diagnostic tests, which may use a swab to collect samples deep in the nose or throat, OraSure’s OraQuick platform would use oral fluid samples such as saliva.
Similar to a home pregnancy test, it could provide results in 20 minutes without any extra equipment or training. The platform has been previously used to detect HIV, the Ebola virus, influenza and hepatitis C.
Previously, the FDA clamped down on home-based coronavirus tests, in part to defend against the myriad fake products being offered online. The agency’s pronouncement late last month said it would pursue warning letters, seizures and injunctions against scammers, while working with legitimate companies to develop self-tests.
But, in addition, the sample collection methods employed by certain home-testing and telehealth companies—and commonly used for COVID-19 testing by healthcare professionals, including painful nasopharyngeal swabs and sensitive molecular sequencing—could be extremely difficult for someone untrained to gather effectively without contamination, especially on themselves. OraSure’s rapid antigen test could avoid that.
“We need to put tests into people’s hands to know their infection status and protect their loved ones,” said BARDA Director Rick Bright. “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,” Bright added.