C-Path Reveals Details of Diagnostic Testing Program.

Will Establish Standardized Evaluation Process for Performance of Diagnostic Tests

TUCSON, Ariz. -- The Critical Path Institute (C-Path) today released additional information about its $2.1 million grant from Science Foundation Arizona (SFAz) to fund a collaborative project with Ventana Medical Systems, Inc. (Ventana) (NASDAQ: VMSI), the U.S. Food and Drug Administration (FDA) and the National Cancer Institute (NCI). The goal of the project is to develop performance standards and an evaluation process for companion diagnostics and their associated targeted cancer therapies.

A newly created program in C-Path, US Diagnostic Standards (USDS), will establish the performance standards for these tests, a critical missing step in the road toward personalized medicine. With the SFAz grant, C-Path and Ventana will work closely with the FDA and NCI to apply the standards to one of Ventana's in-process companion diagnostic tests for lung cancer. With USDS establishing standards and providing an independent assessment of the performance of new tests, the FDA will have greater assurance of the reliability of new diagnostic tests that are submitted for approval.

FDA Commissioner Andrew von Eschenbach, MD, recently said, "Patients with serious illnesses don't just want another drug, they want a solution to their problem." "The award from Science Foundation Arizona will fund an important first step in the development of these medical solutions", noted Raymond Woosley, MD, PhD, President and CEO of C-Path.

Gary J. Kelloff, Senior Scientist at the National Cancer Institute added, "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." William C. Harris, President and CEO of SFAz said, "The 21st century is about brains and speed, and this award for a Strategic Research Group, which includes two of Arizona's most innovative teams of scientists, is certainly capable of capitalizing on both."

About The Critical Path Institute

Headquartered in Tucson, Arizona with offices in Rockville, MD, C-Path was established in 2005 as a publicly funded, nonprofit research and education institute to serve as a trusted third party for collaborations between scientists and others from government, industry and academia. C-Path's mission is to help implement the FDA's Critical Path Initiative by developing faster, safer and smarter pathways to new medical products. Visit www.C-Path.org for more information.