publication date: Aug. 1, 2014

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By Paul Goldberg

FDA announced two plans to resolve a cluster of impediments to personalized cancer care:

• Targeted drugs will need to be approved simultaneously with companion diagnostics that would determine who should—and shouldn’t—get the drug.

• At the same time, the agency will begin phasing in oversight of the essentially unregulated terrain of laboratory-developed tests.

Tests that are intended to select therapy for deadly diseases including cancer would be among the first to be subjected to regulation.

The two actions are interconnected, FDA officials said to the press during a call July 31.

FDA’s Jeffrey Shuren

“The first category [of tests to receive scrutiny by FDA] will be those LDTs for the same intended use of a companion diagnostic we’ve already approved, because at that point you already have a companion diagnostic you know is accurate and reliable to use for directing use for that particular drug,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said at the press call.

Pharmaceutical companies that develop targeted agents have been asking the agency to regulate LDTs for years. However, the agency has been exercising “enforcement discretion,” staying away from requiring validation of such tests.

Now, the boundaries of enforcement discretion will tighten, based on risk posed by the devices in question.

The agency took the following actions:

Continue reading 40-31 FDA Moves to Regulate Lab-Developed Tests

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