FDA guidance on developing genetic tests

FDA is seeking comment on draft guidance covering the data and analyses needed to support approval of pharmacogenetic tests and genetic tests for heritable markers. The guidance applies to submissions for products to test for single or multiple markers, including array-based tests.

The agency said it may be possible to use medical literature as evidence of the effectiveness of "established" markers, while tests using new markers may require clinical validation. Tests designed to assay the presence of a particular pattern, such as a set of SNPs, should ideally be validated in a prospective clinical trial. The guidance is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0012-gdl0001.pdf ...