FDA proposes to regulate lab tests as devices

The U.S. Food and Drug Administration (FDA) has proposed rule changes that would regulate Laboratory Developed Tests (LDTs), including Pacific Edge's Cxbladder, as medical devices under the US Federal Food, Drug, and Cosmetic Act.

If finalised, this would require Pacific Edge and other LDT providers to provide evidence to the FDA that their tests are safe and effective.

The proposed rule change has significant implications for the US clinical testing industry.

The rule would be phased in over a four-year period, and a 60-day comment period is expected to open soon.

Pacific Edge shares the views of industry associations opposing the use of the existing Medical Device framework to assess LDTs. The company has been preparing for this potential regulatory change to minimise disruption to its US operations.