The license permits DxS to commercialise diagnostic and research products that detect mutations in the kinase domain of the EGFR gene
Genzyme Genetics has entered into a sublicense agreement with DxS, 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).
Based in Manchester, UK, DxS is a personalised medicine company providing molecular diagnostics to aid doctors and drug companies in selecting therapies for patients.
DxS has already launched a diagnostic test for EGFR mutation detection which is CE-marked across Europe.
The DxS EGFR kit is used to aid doctors in selecting lung cancer patients suitable for treatment with tyrosine kinase inhibitor therapies such as erlotinib (Tarceva) and gefitinib (Iressa).
"Genzyme's agreement with DxS is illustrative of our strong interest in ensuring global access to this important lung cancer test," said Mara Aspinall, president of Genzyme Genetics.
"It also expands our own reach in offering the most sophisticated cancer diagnostics to better help doctors diagnose and treat their patients.
"We believe that the mutation detection technology employed by DxS will enable the delivery of a superior and highly sensitive test for lung cancer patients around the world".
Through a 2005 agreement with Massachusetts General Hospital and the Dana-Farber Cancer Institute, Genzyme holds the exclusive worldwide diagnostic rights for use of the EGFR gene mutations in testing for NSCLC tumours.
Genzyme Genetics currently 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.
"Genzyme Genetics is a leader in diagnostic testing and we are pleased to work together to bring EGFR testing to a wider group of NSCLC patients," said Stephen Little, chief executive officer of DxS.
"The importance of a patients EGFR mutation status has become apparent in the last few years as studies have shown that patients that carry mutations in the EGFR gene correlate with responsiveness to tyrosine kinase inhibitor therapies.
"In the exciting era of personalised medicine, this is a leading example of mutation status guiding an oncologist's selection of patients eligible for some drugs".
In September 2007, the National Comprehensive Cancer Network, a not-for-profit alliance of 21 of the world's leading 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 upon the independent evaluation of available scientific evidence integrated with the expert judgment of leading clinicians.
