GENETIC TEST GUIDANCE COULD BE BURDENSOME, INDUSTRY SAYS
Industry is concerned that FDA recommendations on genetic test premarket approval and 510(k) applications may be overly burdensome and restrictive.
Several of the agency's recommendations in a February draft guidance "would present significant hurdles to manufacturers attempting to bring new pharmacogenetic and genetic tests to market," said Carolyn Jones, AdvaMed's associate vice president for technology and regulatory affairs, in a letter to the FDA.
Some of AdvaMed's qualms with the guidance are that:
It discourages enrichment, or selecting patients for a clinical trial based on genetic test results; and
It significantly increases the scope of product evaluation studies by asking firms to demonstrate the clinical validity of a test for a genetic marker in addition to analyzing its performance.
The guidance imposes some common in vitro diagnostic requirements that may not be relevant for genetic or biomarker-based testing, Jones said, adding that it is unclear whether the document applies to comparative genomic hybridization tests, which analyze chromosome structure at the molecular level to screen tumors for genetic changes.
The guidance should also not require separate applications for a device that is specifically designed to target multiple markers, Jones said.