FDA Issues Guidance for Diagnostic Tests Used with Targeted Therapies


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FDAlogoThe FDA issued a new draft guidance to facilitate the development and review of “companion diagnostics”—tests used to help health-care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft document is intended to provide companies with guidance on the agency’s policy for reviewing a companion diagnostic and the corresponding therapy.

One common type of companion diagnostic looks for whether a patient has a specific gene amplification or protein overexpression that could predict whether a drug might benefit the patient or lead to harm. For example, trastuzumab (Herceptin) was approved with a companion test, and testing is routinely performed on women diagnosed with breast cancer to help determine whether the patient should receive the drug.

“These proposed guidelines support the development of innovative new targeted medicines and their corresponding diagnostic tests and are intended to provide manufacturers with greater predictability,” said Jeffrey Shuren, MD, Director of the FDA’s Center for Devices and Radiological Health. “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The draft guidance also clarifies the FDA’s definition of a companion diagnostic, recommends early engagement between the FDA and manufacturers, highlights the FDA’s intention to conduct simultaneous reviews of a drug or biologic therapy and its corresponding companion diagnostic, and identifies instances where the FDA may approve a targeted medicine in the absence of a cleared or approved companion diagnostic.

The FDA is seeking public input on the draft guidance. Comments can be submitted onlin e or in writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. ■



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