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C-Path, Ventana to Work with FDA on Cancer Patient Therapy Matches

The Tucson-based Critical Path Institute and Ventana Medical Systems Inc. (NASDAQ:VMSI) of Oro Valley said that they will work with the federal Food and Drug Administration to set up standards to go with cancer patients with targeted therapies.

The objective of the "US Diagnostic Standards" project is to develop performance standards and an assessment process for so-called "companion diagnostics," opening with lung cancer.

Such standards are seen, as an important absent step in the road towards "personalized medicine.

C-Path and Ventana executives, talking at a press conference, expressed frustration with the present FDA-approval process. Ventana's founder, UA pathologist Dr. Thomas Grogan, said speeding up the approval procedure 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. Additionally to the FDA, the groups plan to work along with the National Cancer Institute.

C-Path created as a public-private FDA partnership that brings together scientists and others from government industry and academia to accelerate safely the procedure for bringing lifesaving therapies to market. Oro Valley-based Ventana, which specializes in cancer-tissue testing, is Tucson's major biotech employer with 660 local employees.



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