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Coalition for 21st Century Medicine Issues Statement in Opposition of Genentech Petition to Restrict Lab Use of Diagnostic Tests for Physicians and Patients

Published in Drug Law Weekly, January 13th, 2009

The Coalition for 21st Century Medicine strongly opposes the citizen petition filed by Genentech, Inc. on December 5, 2008, seeking to restrict the ability of laboratories to offer diagnostic tests to physicians and patients. The request threatens innovation in laboratory tests, would harm patient care and rests on flawed scientific and legal premises.

The Coalition's mission is to encourage the research, development, and commercialization of innovative diagnostic techniques. In contrast, the petition, by requesting that the FDA approve all laboratory tests, would delay the introduction of many critically needed diagnostic tests, and prevent others from ever being...

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