FDA authorisations for Covid-19 antibody tests stall


The pace at which the US FDA is granting emergency use authorisation to tests designed to detect antibodies to the novel coronavirus is beginning to slow. No antibody test has been granted an EUA since May 4. This is good news for the nine companies that have managed to secure authorisation for their tests, especially since these are now reimbursed under Medicare. Developers of tests using a multi-step method, the most common type, will receive $42 per test, the CMS said last week. One antibody test that could gain authorisation in short order is that from Siemens Healthineers. This has gone on sale worldwide, and an EUA application has been made. With Healthineers claiming 100% sensitivity and 99.8% specificity it would seem unlikely that the agency could turn it down for lack of accuracy. The number of EUAs for tests that detect the coronavirus’s RNA, meanwhile, has been ticking up, though since May 15 just five assays have been greenlit by the regulator.

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