Two more test nods as FDA relaxes rules still further


Thanks to the FDA, Hologic and Labcorp have managed to arrest the damage they sustained during yesterday’s bloodbath on the exchanges: their shares are up very slightly after the agency granted emergency use authorisation to their Covid-19 diagnostics. The Hologic test could be particularly beneficial to US efforts to combat the virus if the company can make good on its intentions: it expects to provide tens of thousands of Covid-19 tests this month, rising to nearly 600,000 tests a month in April. That depends, however, on reagent supplies holding out. Meanwhile the FDA has taken a small step back from regulating Covid-19 tests, and will now allow individual states to authorise lab tests. Labs developing tests in these states would engage directly with state authorities, instead of with the FDA, and would not be required to pursue an emergency use authorisation. The FDA also said it would permit the sale of unapproved serological tests that detect antibodies to the coronavirus. Those tests are less complex, but also less accurate; the FDA’s guidance states that results from antibody testing should not be used as the sole basis to diagnose or exclude Covid-19 infection.

US FDA emergency use authorisations for Covid-19 tests 
Date of EUA Company Test  Instrument Turnaround time 1-day share price move
March 16 Labcorp Covid-19 RT-PCR test Applied Biosystems QuantStudio7 Flex 24hr 2%
March 16 Hologic Panther Fusion Sars-CoV-2 assay Panther Fusion 3hr 1%
March 13 Thermo Fisher Scientific TaqPath Covid-19 Combo Kit Applied Biosystems 7500 4hr 5%
March 13 Roche Molecular Systems Cobas Sars-CoV-2 test Cobas 6800 and 8800 3.5hr 13%
Note: excludes academic-developed tests. Source: FDA and company communications.

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