FDA Covid-19 test authorisations flatline

There is no denying that the number of emergency authorisations granted for Covid-19 tests has slowed sharply this month. Only five new tests or sample collection kits gained the FDA’s blessing over the course of November. It is hard to say why this might be. It is unlikely that diagnostics developers feel the market is saturated, since demand in the US for Covid-19 tests is so high that some test makers have reported delays – Quest Diagnostics, for example, said last week that the average turnaround time for its molecular tests had increased to 2-3 days. Perhaps development of new tests has slowed, with companies focusing more on ramping up production of assays that have already been authorised. But there are still some novel assays awaiting the FDA’s attention, such as Siemens Healthineers’ quantitative test for neutralising antibodies. The agency is gearing up to consider authorising the two leading vaccine candidates, from Pfizer/Biontech and Moderna, in December; should these get the nod, and the shots work as well as expected, the market for Covid-19 tests will slowly diminish across 2021. But currently demand is strong amid the autumn surge. An increase in the rate of test authorisations would be no bad thing.

Note: "Other" includes seven antigen tests, six home sampling kits, three saliva collection devices and two IL-6 tests. 

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