New FDA Draft Guidance Addresses Companion Diagnostics

By Kelly A. Briganti, Editorial Director, G2 Intelligence

The U.S. Food and Drug Administration (FDA) released another draft guidance document last week that addresses diagnostics.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 On July 15 the agency issued draft guidance addressing companion diagnostics: “Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product.”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

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

The FDA also announced webinars are planned for July 27 concerning the next generation sequencing and variant database guidances. Those webinars will consider the technical and regulatory aspects of the draft guidances and the impact of the guidance on patients and providers.

For more information about the FDA’s webinars see www.fda.gov/CDRHwebinar.