FDA launches pilot program to help reduce risks associated with using laboratory developed tests to identify cancer biomarkers

June 21, 2023
Pilot geared toward sponsors of certain oncology drug products used with certain in vitro diagnostic tests to identify patients for certain cancer treatments.

The U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients.

Through the pilot program, the FDA will request, from drug manufacturers, performance information for the tests used to enroll patients into the clinical trials that support drug approval.  Based on an assessment of that information, the FDA will post to the FDA website the minimum performance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug. Laboratories may use this information to guide their development of LDTs to identify specific biomarkers used for selecting cancer treatment. This transparency aims to help facilitate better and more consistent performance of these tests, resulting in better drug selection and improved care for patients with cancer.

As discussed in the guidance, the initial phase of the pilot program is anticipated to last up to one year, during which the FDA will evaluate no more than nine drug sponsors for possible acceptance into the pilot. The minimum recommended performance characteristics for in vitro diagnostic tests used with each approved drug product under the pilot, based on the clinical trial assays, will be made publicly available on the FDA’s website following drug approval.

FDA release