DxS, a personalised medicine company, has entered into a collaboration agreement with Bristol-Myers Squibb Company (NYSE: BMY) and ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company (NYSE: LLY), to further develop a K-RAS companion diagnostic for ERBITUX® (cetuximab) in the United States and Canada.
If approved by the U.S. Food and Drug Administration, the DxS TheraScreen®: K-RAS Mutation Kit would become a companion diagnostic for use with ERBITUX in metastatic colorectal cancer (mCRC) to determine which patients have wild-type K-RAS status in the United States. The DxS TheraScreen: K-RAS Mutation Kit detects K-RAS mutations in codons 12 and 13. The use of monoclonal antibody EGFR inhibitors is not recommended for the treatment of colorectal cancer with mutations in codon 12 or 13. It is estimated that 40 percent of patients with mCRC have K-RAS mutations while the majority, 60 percent, have the wild-type K-RAS gene.
Dr. Stephen Little, CEO of DxS said: “We are very pleased to be continuing our work with Bristol-Myers Squibb and ImClone Systems to ensure K-RAS testing is available to all patients in need of treatment for metastatic colorectal cancer in the United States.”