Companion Diagnostics Regulation Clarification: On the Horizon at the Food and Drug Administration


Federal regulation of diagnostic tests used in companion therapeutic-diagnostic products is seen by some to be a barrier for personalized medicine.  Others argue that definition of a clear, reasonable regulatory pathway for these tests will remove a barrier to personalized medicine. Today, drugs are regulated by one part of the Food and Drug Administration (FDA), lab kits (lab tests sold packaged in ‘boxes’) by another part of FDA, and laboratory test service companies are regulated by the Center for Medicare and Medicaid Services.  Companion diagnostics (lab tests and kits designed inform drug selection or dosage) pose a challenge to this system, and the opportunity to create a better one.

At the suggestion of the FDA, PMC convened a workgroup to suggest alterations to the agency’s 2005 white paper on the subject.  Stakeholders around the table sometimes had competing views, but all agreed that promoting high quality patient care is the central goal. This enabled the groups (including lab service companies, diagnostic kit manufactures, and pharmaceutical companies) to achieve consensus on several over-arching recommendations:

  • Regulation must recognize the various types of companion products and work for all of them.
  • Any oversight of in vitro diagnostic devices and laboratory-developed tests should be developed through an open and transparent process.
  • Regulatory policy should promote rapid access to new diagnostic information to improve clinical care and sustain innovation.

Since FDA has suggested that it might pursue a series of white papers or hold a series of workshops on topics related to companion diagnostic regulation in advance of developing draft guidance on it, PMC also suggested a series of topics that might prove valuable to the community.  They are:

  • Analysis of regulatory precedent for companion diagnostics.
  • Review and analysis of evidence requirements for companion diagnostics and co-developed drug-diagnostic products.
  • Intra-agency coordination among the office for drug regulation, the office for device regulation, and the Office of Combination Products.

The full text of the PMC’s submission to FDA can be found here:

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