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DxS Collaborates with AstraZeneca to Provide a Companion Diagnostic for IRESSA™

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DxS Ltd has announced it is working closely with AstraZeneca to make available a companion diagnostic for use with IRESSA™ (gefitinib), AstraZeneca’s treatment for non small cell lung cancer (NSCLC).

DxS’ clinical diagnostic, the TheraScreen®: EGFR29 Mutation Kit will be used to test the mutation status of a patient’s EGFR oncogene to identify their eligibility for treatment with IRESSA™.

The TheraScreen®: EGFR29 Mutation Kit, is the only CE-marked kit currently available and is based on DxS’ real-time PCR technology ARMS® and Scorpions® which allows for a highly sensitive and selective test which can detect low levels of mutant in a background of wild type genomic DNA in a tumor with time to result in less than three hours.

The collaboration follows the granting of marketing authorization for IRESSA™ in the EU for the treatment of adults with locally advanced or metastatic NSCLC with activating mutations of EGFR-TK across all lines of therapy. IRESSA™ acts by inhibiting the tyrosine kinase enzyme in the Epidermal Growth Factor Receptor (EGFR), thus blocking the transmission of signals involved in the growth and spread of tumors.

In around 10-15 percent of NSCLC cases in Caucasians, a mutation in the EGFR pathway causes tumors to be particularly susceptible to treatment with IRESSA, making the use of a companion diagnostic to identify those most suitable for treatment extremely important. The EU authorization is based on a submission package including two pivotal Phase III studies, IPASS and INTEREST.

Dr Stephen Little, CEO of DxS said: “We are very pleased to be working with AstraZeneca to provide a diagnostic for use with IRESSA™. The results from the IPASS trial show just how important the development of a companion diagnostic is for use with IRESSA in ensuring that patients most likely to benefit receive the therapy. We hope that through the better understanding of the relationship between EGFR mutation status and response to anti-EGFR therapies such as IRESSA™, patients receive the best possible cancer treatment.”