FDA will recognize a regulatory category called “complementary diagnostics” for tests that provide additional information about how a drug might be used, but that are distinct from “companion diagnostics,” which are essential for the safe and effective use of a drug.

Elizabeth Mansfield, Deputy Director for Personalized Medicine in the Office of In Vitro Diagnostics and Radiological Health at FDA, stated at a recent conference that the agency will be focusing on complementary diagnostics, in addition to companion diagnostics, as part of the new framework to regulate LDTs the agency announced in two draft guidance documents last year.  Mansfield discussed laboratory tests for genomic markers to indicate whether a patient should be treated with certain classes of drugs (rather than a particular drug). An FDA spokeswoman subsequently provided to Bloomberg BNA the example of a cluster of genes that are expressed in a “signature” pattern and linked to a certain disease. The spokeswoman said that FDA has not yet formally labeled any tests as complementary diagnostics.

FDA is increasingly focused on the agency’s role in the development of personalized medicine products, stemming from the agency’s 2013 report outlining various personalized medicine initiatives at the agency.  The agency’s 2016 budget includes increases in funding for precision medicine to permit FDA to keep pace with scientific advancements and help speed the development and evaluation of precision diagnostics and therapeutics.  In addition, in January of this year, President Obama announced the launch of a new Precision Medicine Initiative to intensify efforts to apply precision medicine to the development of cancer treatments.  As part of that initiative, FDA is evaluating the appropriate regulatory approach to next generation sequencing technologies and held a workshop on the topic in February.