FDA approves Abbott’s rapid portable COVID-19 test
pharmafile | August 27, 2020 | News story | Research and Development | Abbott, COVID-19, FDA, test
The FDA has given emergency clearance for Abbott’s portable COVID-19 test that it will sell for just $5.
The company’s BinaxNOW COVID-19 Ag Card test can give results within 15 minutes and is designed to be administered in places like schools and workplaces to carry out mass testing. However, the test still needs a nasal swab to be administered by a medical professional.
Joseph Petrosino, a Professor and Chairman of molecular virology and microbiology at the Baylor College of Medicine in Houston, said: “The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing. With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don’t spread the virus.”
This follows the FDA granting Emergency Use Authorization back in March to Abbott’s ID NOW rapid molecular test that can provide results in 30 minutes and can be used in doctor’s office labs and nursing homes.
The new test is different as it uses a companion mobile app for iPhone and Android to quickly display the results. Abbott says the test will ship by the end of the month and it will produce 50 million tests by October.
Robert Ford, the President and Chief Executive of Abbott, said: “We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives. BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a digital health tool to help us have a bit more normalcy in our daily lives.”
Conor Kavanagh
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