US authorisation arrives for point-of-care Covid-19 tests


In the past week the US FDA has granted emergency use authorisation for a further seven in vitro diagnostics for Covid-19 infection, bringing the total to 16. Smaller groups like Mesa Biotech and Avellino join relative majors including Perkinelmer and Biomérieux in gaining the agency’s backing for their tests for the coronavirus. Mesa’s technology is particularly interesting: its handheld Accula device, which got EUA on Monday, is designed to enable testing wherever the patient presents, and can give results in about 30 minutes. Still, this device will be unable to process the volume of samples that the large, high-throughput instruments from larger groups like Roche and Hologic can offer. On the same day the FDA granted an EUA for a test developed by Biomérieux's subsidiary Biofire Defense. The Biofire Covid-19 test was developed with funding from the US Department of Defense under an existing contract, and has a turnaround time of around 45 minutes. Biomérieux is working on two other Covid-19 tests, one of which is a panel intended to diagnose Covid-19 plus 21 other common respiratory pathogens. The full list of EUAs granted to date can be found here.

Share This Article