Sun, Jul 05, 2009

Business

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

By Jack Gillum
Arizona Daily Star
Tucson, Arizona | Published: 10.11.2007
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."
The US Diagnostic Standards project is part of a previously announced $2.1 million grant from Science Foundation Arizona. In addition to the FDA, the groups plan to work with the National Cancer Institute.
C-Path was created as a public-private FDA partnership that brings together scientists and others from government industry and academia to safely accelerate the process for bringing lifesaving therapies to market. Oro Valley-based Ventana, which specializes in cancer-tissue testing, is Tucson's largest biotech employer with 660 local employees.
● Contact reporter Jack Gillum at 573-4178 or at jgillum@azstarnet.com.