Virus Testing Push Leaves FDA Lab Oversight in ‘a Bizarre Limbo’

More tests to screen for a variety of ailments will hit the market without FDA oversight under an HHS policy meant to make more Covid-19 tests available, muddying the debate over the agency’s role.

While the Food and Drug Administration oversees tests developed by commercial companies like Quest Diagnostics, it has more sparingly applied its authority over individual tests developed by labs at health-care centers and universities. The FDA had required an emergency use authorization for these lab-developed tests (LDTs) for Covid-19, but last week the Department of Health and Human Services did away with even that cursory oversight to ...