Virax Biolabs Group Limited announced that their supplier has received an Emergency Use Authorization from the U.S. FDA for their Over-the-Counter COVID-19 Rapid Antigen Test. The Tests are ready for sale in the US 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. COVID-19 remains a significant healthcare burden in the United States. According to the CDC, as of November 23, 2022, there have been approximately 45 million cases with around 250,000 deaths attributable to COVID-19 so far in 2022. Total test volume has been over 266 million in the US 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.