Resources for Food and Drug Administration (FDA)

C-Path, Ventana to work with FDA on cancer patient-therapy matches

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The Tucson-based Critical Path Institute and Ventana Medical Systems Inc. of Oro Valley said Wednesday that they will work with the federal Food and Drug Administration to establish standards to match cancer patients with targeted therapies.
The goal of the "US Diagnostic Standards" project is to develop performance standards and an evaluation process for so-called "companion diagnostics," starting with lung cancer.
Such standards are seen as a critical missing step in the road toward "personalized medicine."
C-Path and Ventana executives, speaking at a Wednesday press conference, expressed frustration with the current FDA-approval process. Ventana's founder, UA pathologist Dr. Thomas Grogan, said speeding up the approval process is "a question of doing the right thing for every patient."

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