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DxS to Team with BMS, ImClone on Erbitux Dx

NEW YORK (GenomeWeb News) – DxS will collaborate with drug developers Bristol-Myers Squibb and Eli lilly subsidiary ImClone Systems to continue development of a companion diagnostic for the drug cetuximab, which is marketed as Erbitux, in the US and Canada, DxS said today.

The DxS TheraScreen K-RAS Mutation Kit will serve as a diagnostic for colorectal cancer patients who may be candidates for the drug. The test, which has not yet been cleared by the US Food and Drug Administration, was designed to determine which patients have wild-type K-RAS status in order to help doctors decide if cetuximab is an advisable treatment.

Cetuximab was developed by ImClone and has been licensed to BMS for commercialization in the US and Canada, and to Merck KGaA for commercialization outside the US and Canada. In Japan, the drug is sold by ImClone, BMS, and Merck KGaA.

The drug is not recommended for metastatic colorectal cancer patients with that mutation in codon 12 or 13. Around 60 percent of mCRC patients have the wild-type K-RAS gene.

The American Society of Clinical Oncology and the National Comprehensive Cancer Network have recommended that doctors test all mCRC patients for K-RAS variants before they are treated with anti-EGFR antibody therapies such as cetuximab.

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