Genzyme Genetics, Cambridge, Mass, has signed a sublicense agreement with DxS Ltd, Manchester, UK in which it will grant DxS worldwide rights—with the exception of North America and Hong Kong—for diagnostic testing of epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC).

The license permits DxS to commercialize diagnostic and research products that detect mutations in the kinase domain of the EGFR gene.

Genzyme Genetics is a nationwide provider of genetic testing and genetic counseling services for physicians and their patients. DxS is a personalized medicine company that provides molecular diagnostics to aid doctors and drug companies in selecting therapies for patients.

DxS has launched a diagnostic test for EGFR mutation detection, which is CE-marked across Europe. The kit aids doctors in selecting lung cancer patients suitable for treatment with tyrosine kinase inhibitor therapies such as erlotinib (Tarceva™) and gefitinib (Iressa™).

Through a 2005 agreement with Massachusetts General Hospital and the Dana-Farber Cancer Institute, Genzyme holds exclusive worldwide diagnostic rights for use of the EGFR gene mutations in testing for NSCLC tumors. Genzyme Genetics offers EGFR mutation analysis tests to identify gene mutations that have been reported to correlate with patient response to certain drugs for second- and third-line NSCLC therapy.

In September 2007, the National Comprehensive Cancer Network, a not-for-profit alliance of 21 worldwide cancer centers, published clinical practice guidelines for NSCLC that recommend testing for EGFR mutations among other molecular abnormalities that may be able to predict for sensitivity and resistance to EGFR tyrosine kinase inhibitor drugs. The development of NCCN information is based on the independent evaluation of available scientific evidence integrated with the judgment of clinicians.
Genzyme Analytical Services offers clinical trial testing services for EGFR mutations to pharmaceutical and biotechnology companies conducting global clinical trials.