FDA opens discussion on guidance for companion diagnostics

September 1, 2011

FDA issued a new draft guidance to facilitate the development and review of companion diagnostics-tests used to help clinicians determine optimal pharmaceutical use.

WASHINGTON-FDA issued a new draft guidance to facilitate the development and review of companion diagnostics-tests used to help clinicians determine optimal pharmaceutical use. The draft document is intended to provide guidance on the agency's policy for reviewing a companion diagnostic and the corresponding drug therapy.

One common type of companion diagnostic determines whether a patient has a specific gene amplification or protein overexpression that could predict whether a drug might benefit the patient. For example, in 1998, FDA approved Herceptin (trastuzumab), a breast cancer drug designed to target HER2 gene amplification or HER2 protein overexpression. The drug was approved with a companion gene test.

Today, testing is routinely performed on women diagnosed with breast cancer to help healthcare professionals determine whether the patient would benefit from Herceptin.

ENTITIES MUST COLLABORATE

Jeffrey Shuren, MD, director of FDA's Center for Devices and Radiological Health, said in a release that it is the agency's goal "to help stimulate early collaborations between drug and device makers so they can develop the best medical products for treating patients."

The draft guidance also clarifies FDA's definition of a companion diagnostic and identifies instances where FDA may approve a targeted medicine when the potential benefits outweigh the risks of not having a cleared or approved companion diagnostic. The therapy could be approved first while the companion diagnostic may be approved or cleared later through the appropriate device submission process.