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COVID-19 Rapid Antigen Test Distributed By Virax Biolabs Receives Emergency Use Authorization in the United States
Kits available Now for Distribution LONDON, Dec. 6, 2022 /PRNewswire/ -- Virax Biolabs Group Limited ("Virax" or the "Company") (Nasdaq: VRAX), an innovative
About this update from Virax Biolabs Group Limited
[{"type":"text","content":"Kits available Now for Distribution\nLONDON, Dec. 6, 2022 /PRNewswire/ -- Virax Biolabs Group Limited (\"Virax\" or the \"Company\") (Nasdaq: VRAX), an innovative biotechnology company focused on the prevention, detection, and diagnosis of viral diseases, announced today that 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 \"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. \n\n \n \n \n \n \n \n\n \nVirax's Chairman of the Board and Chief Executive Officer, James Foster commented \"This is an important milestone for Virax as we now have the ability to enter into the key US market. 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.\"\nCOVID-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. \nThe 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.\nAbout Virax Biolabs Group LimitedFounded in 2013, Virax Biolabs is an Innovative Biotechnology company focused on the diagnosis of and the detection of immune responses to viral diseases.\nIn addition to distributing an array of viral test kits in unique geographies, Virax Biolabs Group Limited is currently developing a proprietary T-Cell Test technology with the intention of providing an immunology profiling platform that assesses each individual's immune risk pr...