With a press release, guidance document, and comment period, FDA launches a pilot program. Drug developers will release performance criteria for tests (such as gene mutations) used in clinical trials. This will allow labs, prior to marketing authorization (e.g. LDT not IVD or LDT not PMA) to match the performance critera.
FDA notes, as everyone knows, that it tries to release new drugs and required companion diagnostics in their PMA/IVD form at the same time. But it's also true, from time to time, that the drug is approved months before the diagnostic is, so the drug can only be used with LDTs in that interval.
- FDA writes,
- "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."
- Adding, "Laboratories may use this information to guide their development of LDTs to identify specific biomarkers used for selecting cancer treatment..."
- The program wants to "address concerns and questions around the use of unauthorized diagnostics."