Virax Biolabs, a biotechnology company focused on the prevention, detection, and diagnosis of viral diseases, announced their supplier has received an Emergency Use Authorization (EUA) from the U.S. FDA for their over-the-counter COVID-19 rapid antigen test.

The tests are ready for sale in the U.S. by Virax. Additionally, another point-of-care rapid antigen test to be distributed by Virax is seeking an approval with Health Canada for Canadian distribution. The tests have been eligible for sale in markets accepting the CE Mark since 2020.   

“This is an important milestone for Virax as we now have the ability to enter into the key U.S. market,” says James Foster, Virax’s chairman of the board and CEO. “COVID-19 remains a major viral threat and has become endemic. We have significant manufacturing capacity (through our partner) of up 2 million tests per day which will allow us to serve a large portion of the US market, if necessary. We look forward to updating you on distribution contracts as they are signed.”

According to the CDC, as of Nov. 23, 2022, there have been approximately 45 million cases of COVID with around 250,000 deaths attributable to the infection so far in 2022. Total test volume has been over 266 million in the U.S. in 2022. 

The test is intended for non-prescription self-use and for an adult lay user to test another person 2 years of age or older in a non-laboratory setting via a nasal swab. The test seeks to identify infections related to COVID-19 with results typically available in 10 minutes. Testing in symptomatic subjects indicate 98.8% sensitivity and 97.2% specificity.