The FDA has issued an Emergency Use Authorization (EUA) for the Novacyt COVID-19 test. As a result, hospitals and laboratories in the United States will be able to use the test for clinical diagnosis of COVID-19. The test is available for immediate distribution in the US market. The French group also announced that its RUO COVID-19 test has been approved by the Indonesian Ministry of Health, thereby opening a new market.
Graham Mullis, CEO of Novacyt, says: "The clearance received from the US FDA is further important proof of the performance and quality of our COVID-19 test, which once again demonstrates the growing role of Novacyt in fighting against this pandemic. We are committed to providing our COVID-19 test to clinicians around the world and are delighted to be able to support the US market now. "
" ..This represents approximately 18 months of total sales for the division under normal circumstances and already exceeds the total sales achieved by Primerdesign in 2019. All Novacyt staff and the Company's recently appointed manufacturing partner are working at full capacity to fulfil this demand. "
This has been achieved in just 6 weeks, imagine what the next 6 or 12 or 18 weeks will bring, We could have 5 years sales in the next 3 months alone, and thats without every other product we produce