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BOULDER, Colo., and PLEASANTON, Calif., June 2, 2011 /PRNewswire/ -- Clovis Oncology, Inc. and Roche (SIX: RO, ROG; OTCQX: RHHBY), announced today that they have entered into an agreement to develop an in vitro PCR (Polymerase Chain Reaction) based companion diagnostic test. The goal is to identify activating epidermal growth factor receptor (EGFR) mutations in patients with non-small cell lung cancer (NSCLC), including the EGFR T790M mutation.  

"Once again we are able to demonstrate Roche's expertise in Personalized Healthcare. Our agreement with Clovis Oncology strengthens our position as the partner of choice for the development of companion diagnostics. Roche hopes that through this collaboration we will be able to advance oncology diagnostic testing and drug therapy for the benefit of many patients world-wide," said Paul Brown, Head of Roche Molecular Diagnostics.

Patrick Mahaffy, President and CEO, Clovis Oncology added: "We are very pleased to partner with Roche, a clear leader in the development, manufacturing and marketing of companion diagnostic tools.  By incorporating a companion diagnostic during clinical and commercial development of CO-1686, we reinforce our commitment to focus development programs on specific subsets of cancer populations that are most likely to benefit from our targeted therapies."

About CO-1686

CO-1686 is currently in pre-clinical development for advanced NSCLC patients.  CO-1686 has been designed to target and covalently bind to the activating and T790M mutant forms of EGFR.  It does so while also sparing wild-type (normal) EGFR and may thus treat refractory NSCLC while minimizing dose-limiting side effects.   CO-1686 was licensed to Clovis Oncology from Avila Therapeutics, Inc.

About the cobas 4800 system

The cobas EGFR mutation assay will run on the Roche cobas 4800 System, a platform designed to deliver new standards in laboratory testi

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