FDA Issues Draft Guidelines for Companion Diagnostics

The U.S. Food and Drug Administration (FDA) released another draft guidance addressing diagnostics. Earlier this month, two guidances addressed next generation sequencing and variant databases that support clinical validity of genetic tests. July 15, the agency issued draft guidance addressing companion diagnostics: “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.”

The FDA indicates the document is intended to guide in vitro diagnostic device (IVD) and therapeutic product sponsors in codeveloping their products and seeking “contemporaneous marketing authorization.” The new draft is a follow-up to a 2014 guidance document which defined in vitro diagnostic devices and encouraged earlier development of companion diagnostics. The FDA’s announcement of this latest guidance indicates it “provides general principles for addressing issues that may arise when codeveloping a therapeutic product and a corresponding IVD companion diagnostic. It also provides considerations for planning and executing clinical trials and successfully fulfilling FDA regulatory requirements.”

Reiterating the 2014 definition of IVD companion diagnostics, this new guidance highlights four uses for these diagnostics:

ffDetermining who will benefit from a therapy ffDetect those who might suffer adverse reactions to products ffMonitor and guide adjustment to treatment ffID patients for whom a product is safe and effective

Noting that “[c]odevelopment of IVD companion diagnostics and therapeutic products is critical to the advancement of precision medicine,” the FDA indicates that it won’t approve a therapeutic product or a new indication for one if a companion diagnostic is “essential to assuring safety or effectiveness” and hasn’t already been approved or is contemporaneously being approved for market. The 13-page 2014 guidance focused on defining IVD companion diagnostics, describing general FDA policies regarding review of therapeutic and companion diagnostic products, and ensuring consistency between labeling for the therapy and the diagnostic. This latest 48-page guidance document covers codevelopment planning, clinical trial design considerations, development of IVD companion diagnostics later in the process of developing a therapeutic product, contemporaneous marketing authorizations, as well as labeling and post market considerations.

An Aug. 18 webinar will provide more information about the guidance and answers to questions. Public comments on the guidance should be submitted by Oct. 13, 2016 to be considered before issuance of the final guidance. For more information about the FDA’s webinar click here.

Takeaway: Recognizing the importance of diagnostics to precision medicine, FDA provides guidelines for contemporaneous development and approval of companion diagnostic and therapeutic products.