April 2020

On April 13th, 2020, The Food and Drug Administration (FDA) published a final guidance entitled “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products,” in which the FDA lists several key considerations for companion diagnostic manufacturers who are considering a class-based label and provides clarification on the process required to be granted a class-based label1. The FDA developed this guidance following recommendations made in a 2018 draft guidance, which lacked clarification regarding which companion diagnostics class labeling is appropriate for and how class labeling should be pursued by companion diagnostic manufacturers.

In the 2020 guidance, The FDA outlines the following considerations to determine if a companion diagnostic may seek a broad class-based label:

  1. A companion diagnostic is not appropriate for broader labeling if a specific group of oncology therapeutic products* cannot be defined, or once defined, analytical and clinical evidence does not support usage of this defined group as an appropriate treatment for a specific patient population
  2. A broad label is not appropriate if other therapeutics in the specific therapeutic or relevant biomarkers may interact in a way that affects the mechanism of action of a therapeutic product included in the specific therapeutic group
  3. A broad label is only appropriate if there is sufficient clinical experience with at least two therapeutic products for the same biomarker-informed indications
  4. A broad label is only appropriate if analytical validity of the companion diagnostic has been demonstrated across the range of biomarkers that inform the indication.
  5. A broad label is only appropriate if clinical validity of the companion diagnostic has been demonstrated with the therapeutic products in the disease of interest

The FDA encourages manufacturers considering development of a broad label companion diagnostic to meet with the Center for Devices and Radiological Health (CDRH), Center for Biologics Evaluation and Research (CBER), or Center for Drug Evaluation and Research (CDER) to discuss the appropriate clearance pathway. In the case of a manufacturer considering broad label expansion for an existing companion diagnostic, the FDA encourages meetings with the CBER or CDRH.

The new guidance has several potential implications for manufacturers of both companion diagnostics and oncology therapeutics. Companion diagnostics that are granted class-based indications may experience continued expansion of their indication without additional regulatory burden if more therapeutics of the same class are developed and released. Conversely, companion diagnostics that are currently the sole test for a given therapeutic may experience market share erosion as the FDA grants class-based labeling to other related companion diagnostics. Manufacturers of oncology therapeutics may experience an increase in the number of tests that can be used to assess patient suitability for their drug. This new guidance could also incentivize investment in new drugs that could potentially qualify as part of a class already covered by a future existing diagnostic. However, the scope of impact on both companion diagnostics and oncology therapeutics will depend on how many biomarkers fulfill the requirements of broad labeling.

To learn more about the FDA’s new guidance for companion diagnostic manufacturers and implications for CDx innovators please contact us.

[1] Food and Drug Administration. Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products Guidance for Industry.; 2020. https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Accessed April 15, 2020.
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