BASEL, Switzerland—Last month, Roche announced that itsigned three important collaboration deals in the diagnostic arena: one withGenzyme Corp. to develop a diagnostic assay for the detection of EpidermalGrowth-Factor Receptor (EGFR) mutations; one with OSI Pharmaceuticals Inc.(OSI) for the development of a PCR-based companion diagnostic test to identifypeople with non-small cell lung cancer (NSCLC) that harbors EGFR activatingmutations; and finally, one with CapitalBio, a Beijing-based developer andmarketer of diagnostic biochips, microarray related instruments and microarrayservices, which will target molecular diagnostic applications and thedevelopment of technologies to fill the unmet needs of researchers worldwide.
TheEGFR mutation assay involved in the Genzyme agreement will run on Roche's cobas4800 System, currently approved for use in detecting infectious microorganismssuch as human papillomavirus (HPV), chlamydia and gonorrhea. In addition totesting for the EGFR mutation, Roche is exploring other oncology applicationsfor the cobas 4800 platform.
DanielO'Day, head of Roche's diagnostics division, says the companion diagnostic testinvolved in the OSI agreement will "enhance physicians' ability to customizethe use of Tarceva for people with advanced NSCLC."
Tarcevais the only EGFR inhibitor approved by both the U.S. Food and DrugAdministration and European Medicines Agency for use in maintenance andsecond-line treatment settings for the treatment of patients with advanced ormetastatic NSCLC with and without EGFR activating mutations.
Thepartnership with CapitalBio plans to focus initially on the research anddevelopment of instruments and products to enhance and automate the RocheNimbleGen microarray workflow and the application of this workflow inpreventive and personalized diagnostics. According to the partners, this new collaborationbuilds on the genomics and diagnostics expertise of the two companies and willfocus on furthering microarray technologies and complementary products formolecular diagnostic applications.
CapitalBiorecently established an Independent Medical Testing Laboratory in Chengdu,China, and has expanded its Microarray Genomics Service Facility at its Beijingheadquarters. The partnership plans closer cooperation and collaboration acrossa broad range of advanced molecular diagnostic assays for clinical diagnosticsand medical research, including the use of 454 Life Sciences' next-generationsequencing for medical services.
Specialfocus will be placed on cooperation in education on the benefits and use ofmolecular diagnostics that exploit novel technologies involving microarrays andtheir related products and next-generation sequencing in both the greater Chinaand international markets. The partnership also plans to establish educationalfacilities across China for molecular R&D and the application of clinicalmolecular diagnostics.
"Thisagreement is a significant step for Roche in forming closer relations withChina's premier biochip development company," says Dr. Manfred Baier, head ofRoche Applied Science.
Rochetells ddn the financial details of these agreements areconfidential.