Clovis Oncology, Inc. and Roche, 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 testing efficiency and medically relevant diagnostic information. Cobas 4800 was recently approved in the US and all countries accepting a CE mark for use with the HPV test.
About Clovis Oncology, Inc.
Clovis Oncology, Inc. is a biopharmaceutical company focused on acquiring, developing and commercializing innovative anti-cancer agents in the U.S., Europe and additional international markets. Clovis intends to target development programs at specific subsets of cancer populations, and will simultaneously develop diagnostic tools that direct a compound in development to the population that is most likely to benefit from its use. The Company is headquartered in Boulder, Colorado, and has additional offices and laboratories in San Francisco and Cambridge, England. For more information about Clovis Oncology, please visit the Company’s website at www.clovisoncology.com.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80,000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
For Clovis Oncology
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SOURCE Clovis Oncology, Inc.; Roche Molecular Systems, Inc.
