FDA Issues Draft Guidance for Companion Diagnostics

There is a current focus on labeling in vitro companion diagnostic devices for certain cancer drugs.

U.S. Representatives Larry Bucshon (R-IN) and Diana DeGette (D-CO), members of the House Energy & Commerce Committee, have been working for two years to advance new legislation that would modernize regulations for diagnostic devices and tests. The original version of their bill –– the Diagnostic Accuracy and Innovation Act (DAIA) –– was recently revised to incorporate the approach proposed by the FDA in a recent draft guidance. The new version is being referred to as the Verifying Accurate, Leading-edge IVCT Development (VALID) Act. The big difference: the FDA’s guidance includes a precertification program as the central piece of its new regulatory framework.

One of the issues with the process used to date is approval of companion diagnostics with labels that reference the specific therapeutic product(s) for which trials were conducted, limiting their potential use with additional drugs.

The bipartisan legislation was developed in close collaboration with the FDA and incorporates the key aspects of the draft guidance. The FDA indicated that it worked with patient groups, providers, lawmakers and others to develop the framework outlined in the draft guidance. The framework is similar to the one used for medical device approvals, but with a focus on high-risk tests and the use of a precertification program for low-risk tests.

The FDA’s approach is to treat laboratory developed tests (LDTs) and FDA-reviewed diagnostic tests within the same framework to increase patient safety. The agency wishes to focus on tests with the highest risk (~10% would require premarket review) that have post-marketing authority (e.g., the ability to pull unsafe tests from the market) and establish transparent requirements for test outcomes and limits, leverage third-party reviews and inspections and be able to use an accelerated approval pathway for “breakthrough technologies,” with the latter needing a precertification pathway.


Cynthia A. Challener, Ph.D.

Dr. Challener is an established industry editor and technical writing expert in the areas of chemistry and pharmaceuticals. She writes for various corporations and associations, as well as marketing agencies and research organizations, including That’s Nice and Nice Insight.