Bloomberg BNA reports (subscription required) that 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in addition to companion diagnostics, as part of the new framework to regulate LDTs the agency announced in two draft guidance documents last year.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.

Photo of Christina Kuhn Christina Kuhn

Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.…

Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.

Christina frequently helps multinational device manufacturers as well as start-up device companies navigate the premarket regulatory process, advising companies on regulatory classification, clinical development strategy, and agency interactions. She also has significant experience counseling medical device companies on postmarket compliance requirements, including those related to advertising and promotion, quality systems and manufacturing, medical device reporting, registration and listing, and recalls. She advises clients on responding to and resolving enforcement actions, such as FDA inspections and Warning Letters as well as Department of Justice investigations.

Christina advises clients on, and performs regulatory due diligence for, corporate transactions, including acquisitions, public offerings, co-development agreements, and clinical trial agreements.

Christina also regularly assists industry associations and medical device and pharmaceutical companies in commenting on FDA guidance documents and rulemaking as well as drafting and analyzing federal legislation.

Christina is a frequent contributor to Covington’s Digital Health and InsideMedicalDevices blogs.