Press Announcements > FDA seeks comment on proposed policy for diagnostic tests used with targeted drug therapies

The U.S. Food and Drug Administration today issued a new draft guidance to facilitate the development and review of companion diagnostics – tests used to help health care professionals determine whether a patient with a particular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 over-expression that could predict whether a drug might benefit the patient or lead to harm. For example, the FDA in 1998 approved Herceptin (trastuzumab), a breast cancer drug designed to target HER2 gene amplification or HER2 protein over-expression. The drug was approved with a companion test and today testing is routinely performed on women diagnosed with breast cancer to help health care professionals determine whether or not the patient should receive Herceptin.

The FDA is seeking public input on the draft guidance for 60 days. Comments can be submitted online or in writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For more information, please visit: In Vitro Companion Diagnostic Devices ► Press Announcements > FDA seeks comment on proposed policy for diagnostic tests used with targeted drug therapies: "- Enviado mediante la barra Google"

FDA Basic Video: Alberto Gutierrez Interviewed on Diagnostic Tests and Personalized Medicine (video)►
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm195692.htm

Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices
PDF Printer Version1DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Document issued on: July 14, 2011 ►
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm262292.htm