DXS has entered into a collaboration agreement with Bristol-Myers Squibb Company and Imclone Systems to further develop a K-RAS companion diagnostic for Erbitux (cetuximab) in the US and Canada.
If approved by the US Food and Drug Administration, the DXS Therascreen: K-RAS Mutation Kit will 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 US.
The 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 per cent of patients with mCRC have K-RAS mutations while 60 per cent have the wild-type K-RAS gene.
Imclone Systems is a wholly owned subsidiary of Eli Lilly and Company.