New Serial Testing Pathway Enables Immediate Screening Claims for EUA Tests

The US Food and Drug Administration on Wednesday expanded on a new streamlined pathway to allow developers to quickly obtain a screening claim for COVID-19 tests.

Addressing test developers during a weekly town hall, Timothy Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said that if an EUA point-of-care or over-the-counter antigen test has a positive predictive value above 80 percent in symptomatic people, it can be immediately authorized to screen asymptomatic people using a serial testing paradigm.

The FDA is anticipating that serial testing will bring unknown performance in an asymptomatic population up to an acceptable level, Stenzel said, but nevertheless will want to measure that for each EUA test, “to confirm that performance in an asymptomatic population reaches that 80 percent or more utilizing serial testing,” he said.

Stenzel emphasized that the CLIA requirements are overseen by the Centers for Medicare and Medicaid Services, and the new pathway does not alter those requirements. However, home-use tests are not subject to CLIA requirements, he noted.

Source: https://www.360dx.com/regulatory-news-fda-approvals/new-serial-testing-pathway-enables-immediate-screening-claims-eua