Visby Medical has announced that the US Food and Drug Administration (FDA) has authorised its rapid PCR Covid-19 test for use at CLIA waived point-of-care settings. Based on an earlier FDA approved Emergency Use Authorization (EUA), the company’s rapid PCR Covid-19 test can now be used by any organisation with a CLIA certification.
Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI, and manufacturing partner Bio-Techne Corporation, announced that the FDA has added Covid-SeroKlir test to its revised EUA for convalescent plasma for treating hospitalised Covid-19 patients. The test can detect the presence and level of SARS-CoV-2 IgG antibodies with 98.8% sensitivity and 99.6% specificity.
Alevo Technologies, a pre-clinical stage medical diagnostics company, has received a CE mark for its be.well Covid-19 Flex Test that will help accelerate testing, treatment and surveillance of the disease. This is the company’s first regulatory approval, while it looks to submit an EUA to the FDA for the same test.