C-Path and Ventana Medical Systems to Collaborate on Developing Standardized Evaluation for Companion Diagnostic Tests and Targeted Cancer Therapies

The Critical Path Institute (C-Path) and Ventana Medical Systems, Inc. (Ventana) released additional information about C-Path’s $2.1 million grant from Science Foundation Arizona (SFAz) to fund a collaboration project with the U.S. Food and Drug Administration (FDA) and the National Cancer Institute (NCI) to develop a standard testing and evaluation process for companion diagnostics and their associated targeted cancer therapies.

Currently, there is no proven development pathway for FDA approval of the necessary companion diagnostic tests and their associated targeted therapies. 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. With the SFAz grant, C-Path and Ventana will work closely with the FDA and NCI to apply these standards to one of Ventana’s in-process companion diagnostic tests for lung cancer.

Gary J. Kelloff, Senior Scientist at the National Cancer Institute said, “We applaud the collaboration among the Science Foundation Arizona, The Critical Path Institute and Ventana Medical Systems on the important project of creating a standardized evaluation process for diagnostic tests. The results of this work will complement the anticipated collaborative project with the NCI.”

C-Path’s Chief Scientific Officer and Principal Investigator on this initiative, Jeffrey Cossman, MD, said, “The award from Science Foundation Arizona will fund an important step toward making the next generation of important patient care solutions a reality. The ultimate goal of the project is to guide the choice of targeted therapy so that patients receive the most effective treatments.”

President and CEO Raymond Woosley, MD, PhD, added, “This is extremely important work, and we are fortunate to have Ventana, a global leader in cancer diagnostics, as our partner.”

Christopher Gleeson, President and Chief Executive Officer of Ventana, commented, “Ventana’s collaboration with C-Path furthers our commitment to personalized medicine and our view that companion diagnostics will increasingly become a key factor in the development and administration of many new cancer therapies.”