Roche has obtained a sublicense from Genzyme to develop a diagnostic assay for the detection of Epidermal Growth-Factor Receptor (EGFR) mutations.
Roche aims to develop Tarceva companion diagnostic test, which detects EGFR activating mutations, to enhance personalised treatment.
Reportedly, Tarceva has clinically demonstrated a survival benefit in a broad range of patients with advanced NSCLC and tumours with EGFR activating mutations have been shown to be particularly sensitive to Tarceva.
Additionally, Roche and OSI Pharmaceuticals have agreed to collaborate on the development of a PCR- based companion diagnostic test to identify people with non-small cell lung cancer (NSCLC) that harbors EGFR activating mutations.
The EGFR mutation assay will run on Roche’s cobas 4800 System, currently approved for use in detecting infectious microorganisms such as human papillomavirus (HPV), chlamydia and gonorrhea.
Roche’s Diagnostic Division head Daniel Day said that the companion diagnostic test will use Roche’s proprietary molecular diagnostics technology and the aim is to provide a simple tool that will quickly identify EGFR activating mutations and so enhance physicians’ ability to customise the use of Tarceva for people with advanced NSCLC.