DxS and AstraZeneca Collaborate on Companion Diagnostic for Gefitinib

The TheraScreen: EGFR29 mutation kit is based on DxS' Scorpions--a real-time polymerase chain reaction (RT-PCR)--and the Amplification Refractory Mutation System (ARMS). The kit detects low levels of a mutant in a background of wild type genomic DNA in a tumor. Results of this sensitive test are available in less than three hours.

Gefitinib has been authorized in the European Union (EU) for treatment of adults with locally advanced or metastatic NSCLC with activating mutations of epidermal growth factor receptor-tyrosine kinase (EGFR-TK), across all lines of therapy. The EU authorization is based on two phase III studies, Iressa Pan-ASia Study (IPASS) and Iressa nonsmall-cell lung cancer Trial Evaluating REsponse and Survival against Taxotere (INTEREST).

Gefitinib inhibits the tyrosine kinase enzyme in the EGFR, blocking the transmission of signals involved in the growth and spread of tumors. In approximately 10% to 15% of NSCLC cases in Caucasians, a mutation in the EGFR pathway causes tumors to be particularly susceptible to treatment with gefitinib, indicating the importance of the companion diagnostic for identifying those most suitable for treatment.

Dr Stephen Little, CEO of DxS said, "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."

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