Qiagen NV added to its growing roster of panels cleared by the U.S. FDA in 2024 with the agency’s nod for its Qiastat-Dx Meningitis/Encephalitis assay. The clearance validates Qiagen’s strategy of developing rapid tests specifically for the U.S. market and builds on the respiratory, gastrointestinal and central nervous system tests already available.

The COVID-19 pandemic drove a large volume of in vitro diagnostic test efforts toward the SARS-CoV-2 virus, such as the Biofire respiratory panel by Biofire Diagnostics LLC, of Salt Lake City, a test for which the U.S. FDA released the special controls.

The wave of home-use tests for the COVID-19 pandemic has amplified the question of how device makers might validate such a test, but there is also the question of how to convert a device from prescription-only (Rx-only) use to over-the-counter (OTC) status to consider. The FDA has provided an update on OTC devices, which indicates that a conversion from prescription-only use to OTC use will require usability testing and a new regulatory filing, but the update conflicts with the agency’s own policy on changes to a device undertaken only to convert the label from prescription to OTC use.

The FDA is becoming more amenable to screening and surveillance tests for the COVID-19 pandemic, although the distinction between test uses is not always clear. Toby Lowe, the associate director of the Office of In Vitro Diagnostics and Radiological Health (OIR), said on the agency’s weekly town hall that the difference between surveillance and screening tests is whether the individuals who are screened can act on the information thus derived.