ARUP Labs

The ruling makes clear that the FDA lacks the legal authority to regulate LDTs, and observers suggest it could also call into question its authority in other areas.

Public health labs have handled most testing thus far for the Texas and New Mexico outbreaks, but commercial labs are beginning to bring molecular measles assays online.

Demand remains low, but lab stakeholders said the industry is significantly better prepared to meet a spike in H5N1 testing needs than it was during the COVID-19 pandemic.