Elizabeth Mansfield, Ph.D., Director of Personalized Medicine, Office of In Vitro Diagnostics, Center for Devices and Radiological Health of the Food and Drug Administration (FDA) announced today at the 2012 Personalized Medicine World Conference that the FDA is targeting the second quarter of 2012 to release the FDA’s Final Guidance for In Vitro Companion Diagnostic Devices. The FDA issued its Draft Guidance for In Vitro Diagnostic Devices on July 14th, 2011.  A summary of the FDA’s Draft Guidance is provided in our July 17th, 2011 post.  Thirty-three comments on the Draft Guidance were received in response to the FDA’s invitation for comments and suggestions. All public comments are available for viewing at www.regulations.gov, docket ID: FDA 2011-D-0215. The commentators represented pharmaceutical companies, diagnostic companies, trade organizations, interested individuals and patient advocacy groups.  

The 2011 Draft Guidance

By way of background, the FDA indicated that the Drat Guidance was intended to assist those (1) who develop a therapeutic product that depends on the use of such a device/test for the product’s safe and effective use, and (2) who develop a companion diagnostic device intended for use with a corresponding therapeutic product. The FDA noted that when diagnostic device results are a determining factor in patient health, the device must provide reliable results. The device cannot fail analytically (e.g., fail to accurately measure protein levels) or clinically (e.g., fail to identify patients accurately). The FDA stated that such Guidance has become more necessary because  therapeutic products increasingly depend on the use of diagnostic tests to be safe and effective.

Companion Diagnostic Tests

Companion diagnostic tests typically fall into two main categories, diagnostic kits and laboratory-developed tests (“LDTs”). Diagnostic tests contain all the reagents and information necessary to carry out the test and are regulated by the FDA as medical devices. The majority of current companion diagnostics are LDTs. LDTs require more extensive sample preparation or/and specialized equipment to perform the tests. The FDA and the Centers for Medicare and Medicaid Services (CMS) have jurisdiction to regulate LDTs. Historically, the FDA has not exercized its regulatory authority over LTDs thereby allowing CMS to regulate LTDs under the Clinical Laboratory Improvement Amendment (CLIA) rules.

Industry Comments

The industry comments addressed all aspects of the Draft Guidance. Treatment of all the issues raised in the comments is beyond the scope of this post. However, a common theme within many of the comments was the need for more clarity and direction regarding what tests would be treated as a “companion diagnostic” by the FDA. Would LDTs be treated as a companion diagnostic and if so, would they be regulated by the FDA ?

Dr. Mansfield addressed this issue today and announced that yes, LDTs that fall within the definition of a companion diagnostic would be treated as such and would be regulated by the FDA. Thus, LDTs linked to a therapeutic will be regulated by the FDA  – a significant departure from the current regulatory oversight of LDTs that are linked to targeted therapeutic treatments.