For the third time in the past four weeks, stocks within the medtech industry climbed to never-before-seen heights as 2021 reared its head. Previous highs have largely been a result of the FDA granting Moderna emergency use authorization for its vaccine candidate and its subsequent rollout to the U.S., joining the one made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX), […]
DiaSorin
DiaSorin gains BARDA funding for COVID-19 testing kit
DiaSorin Molecular announced that it received federal funding from BARDA for its Simplexa COVID-19 direct testing kit. Cypress, Calif.-based DiaSorin’s undisclosed funding total received from the Biomedical Advanced Research and Development Authority (BARDA) is slated to support the validation and submission of the test for FDA 510(k) clearance and the ramp-up of manufacturing capacity for […]
What kinds of COVID-19 tests are out there?
Months into the pandemic, the FDA continues to grant emergency use approval (EUA) to new tests to detect the virus that causes COVID-19 and the antibodies that indicate a person has had it. To date, the FDA has granted EUAs for 171 tests —142 molecular tests, 27 antibody tests, and 2 antigen tests. Given the ever-changing […]
