EGFR Companion Diagnostics Marketed in United States and Canada

Epidermal growth factor receptor (EGFR) was originally used for predicting colorectal cancer patients' response to chemotherapeutic treatment. EGFR has also been identified as an important factor in prescribing effective treatments for non-small cell lung cancer (NSCL). This was recently demonstrated in a study that compared two NSCL cancer treatments, Iressa and Paraplatin. The mutated EGFR gene determined the patients' response to the treatments.

Genzyme (New York, NY, USA) acquired exclusive worldwide diagnostic rights for use of EGFR gene mutations in testing for NSCL cancer tumors in an agreement made in 2005 with Massachusetts General Hospital (Boston, MA, USA; and the Dana-Farber Cancer Institute (Boston, MA, USA). In early 2008 Genzyme granted DxS (Manchester, UK) rights to develop and commercialize diagnostic and research products that detect mutations in the EGFR to all countries in the world, with the exception of the United States, Canada, Mexico, and Hong Kong. This license has been extended to include the United States and Canada. Financial terms were not disclosed.

Dr Stephen Little, CEO of DxS commented, "The extension of this license is particularly timely as EGFR is becoming increasingly important in ensuring [that] patients receive the best cancer treatment. Results from the IPASS study showed a marked difference in patient's response to treatment according to their genetic status, and we expect there will be an increased demand for EGFR tests to ensure patients receive the most effective treatment."

DxS has a range of products including cancer mutation assays and kits, molecular diagnostic technologies, and genetic analysis services. Its TheraScreen can identify genetic tumor mutations affecting how patients respond to cancer therapies, enabling doctors and drug companies to provide the treatment most likely to benefit patients. DxS currently has two different EGFR products; the EGFR29 research kit and a CE-marking diagnostic called TheraScreen, which will be distributed in Europe by Roche Diagnostics early in 2009. The K-RAS assay was chosen as the companion diagnostic for Amgen's colorectal cancer therapy Vectibix.

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