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Roche inks several important diagnostic deals
BASEL, SwitzerlandóLast month, Roche announced that it signed three important collaboration deals in the diagnostic arena: one with Genzyme Corp. to develop a diagnostic assay for the detection of Epidermal Growth-Factor Receptor (EGFR) mutations; one with OSI Pharmaceuticals Inc. (OSI) for the development of a PCR-based companion diagnostic test to identify people with non-small cell lung cancer (NSCLC) that harbors EGFR activating mutations; and finally, one with CapitalBio, a Beijing-based developer and marketer of diagnostic biochips, microarray related instruments and microarray services, which will target molecular diagnostic applications and the development of technologies to fill the unmet needs of researchers worldwide.
The EGFR mutation assay involved in the Genzyme agreement will run on Roche's cobas 4800 System, currently approved for use in detecting infectious microorganisms such as human papillomavirus (HPV), chlamydia and gonorrhea. In addition to testing for the EGFR mutation, Roche is exploring other oncology applications for the cobas 4800 platform.
Daniel O'Day, head of Roche's diagnostics division, says the companion diagnostic test involved in the OSI agreement will "enhance physicians' ability to customize the use of Tarceva for people with advanced NSCLC."
Tarceva is the only EGFR inhibitor approved by both the U.S. Food and Drug Administration and European Medicines Agency for use in maintenance and second-line treatment settings for the treatment of patients with advanced or metastatic NSCLC with and without EGFR activating mutations.
The partnership with CapitalBio plans to focus initially on the research and development of instruments and products to enhance and automate the Roche NimbleGen microarray workflow and the application of this workflow in preventive and personalized diagnostics. According to the partners, this new collaboration builds on the genomics and diagnostics expertise of the two companies and will focus on furthering microarray technologies and complementary products for molecular diagnostic applications.
CapitalBio recently established an Independent Medical Testing Laboratory in Chengdu, China, and has expanded its Microarray Genomics Service Facility at its Beijing headquarters. The partnership plans closer cooperation and collaboration across a broad range of advanced molecular diagnostic assays for clinical diagnostics and medical research, including the use of 454 Life Sciences' next-generation sequencing for medical services.
Special focus will be placed on cooperation in education on the benefits and use of molecular diagnostics that exploit novel technologies involving microarrays and their related products and next-generation sequencing in both the greater China and international markets. The partnership also plans to establish educational facilities across China for molecular R&D and the application of clinical molecular diagnostics.
"This agreement is a significant step for Roche in forming closer relations with China's premier biochip development company," says Dr. Manfred Baier, head of Roche Applied Science.
Roche tells ddn the financial details of these agreements are confidential.