FDA Addressing Safety Issues

Companion diagnostic tests are used to help physicians select appropriate therapies for individual patients and commonly used to detect certain types of gene-based cancers. FDA announced on July 31, that FDA is issuing a final companion diagnostic guidance for the development, review, and approval or clearance of companion diagnostics tests.

The guidance is intended to help companies identify the need for these tests during the earliest stages of drug development and to plan for the development of a drug and a companion test at the same time.

The ultimate goal for the final guidance is to stimulate early collaborations that will result in faster access to promising new treatments for patients living with serious and life threatening diseases. This final guidance finalizes and takes into consideration public comments on the draft guidance issued in 2011.

The FDA has long required premarket review of commercial test kits sold to laboratories, hospitals, clinics, or directly to the public as home test kits. In addition to commercial tests, many laboratories have been developing, using, and marketing their own Laboratory Developed Tests (LDT).

In order to meet the requirements of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), FDA intends to publish a pre-draft guidance on FDA’s proposed risk-based oversight framework for LDTs that are designed, manufactured, and used within a single laboratory. The LDTs may include some genetic tests and tests that are used by healthcare professionals to guide medical treatment for their patients.

The FDA has historically exercised enforcement discretion over LDTs but now these tests may compete with FDA approved tests without clinical studies to support their use. The pre-draft guidance discusses how FDA proposes to establish an LDT oversight framework, including pre-market review for higher risk LDTs.

The pre-draft guidance would also propose to phase in enforcement of pre-market review for other high risk and moderate risk LDTs over time. The agency intends to propose continuing exercise enforcement discretion for low risk LDTs, LDTs for rare diseases, and under certain circumstances, for LDTs where there is no FDA-approved or cleared test.

FDA also intends to publish a draft guidance outlining how laboratories can notify the FDA that they are currently manufacturing and using LDTs, how to provide information about their LDTs, and how they can comply with the medical device reporting requirements.

For more information, go to www.fda.gov.

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