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C-Path, FDA, NCI to Develop Standards for Evaluating Companion Dx/Rx Submissions

NEW YORK (GenomeWeb News) — The Critical Path Institute will use a $2.1 million Arizona state grant to work with the US Food and Drug Administration and the National Cancer Institute to standardize how companion diagnostics and therapies for cancer are evaluated.  
“Currently, there is no proven development pathway for FDA approval of the necessary companion diagnostic tests and their associated targeted therapies,” said Ventana Medical Systems, which will test the resulting process. “The goal of this collaboration is to establish the performance standards that would serve as the model for future FDA co-submissions of these companion diagnostic tests and their targeted drug therapies.”
The collaboration intends to establish performance standards that the FDA could use for future co-submissions of companion diagnostics and cancer drugs. The first test to which the groups plan to apply the standards will be a Ventana-made diagnostic for lung cancer, the company said.
“The ultimate goal of the project is to guide the choice of targeted therapy so that patients receive the most effective treatments," C-Path CEO Raymond Woolsey said in a statement.
C-Path is a publicly funded non-profit based in Tucson, Ariz., that aims to help the FDA implement its Critical Path Initiative. The $2.1 million grant was awarded by Science Foundation Arizona.

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