DxS Further Develops Companion Diagnostic for Erbitux

DxS (Manchester, UK) has entered into a collaboration agreement with Bristol-Myers Squibb (BMS; New York, NY, USA) and ImClone Systems (New York, NY, USA) to develop further a K-RAS companion diagnostic for Erbitux (cetuximab) in the United States and Canada. Financial terms of the agreement were not disclosed.

Erbitux is licensed to Bristol-Myers Squibb for commercialization in the U.S. and Canada and to Merck KGaA (Darmstadt, Germany), for commercialization outside the U.S. and Canada. In Japan, ImClone Systems, Bristol-Myers Squibb, and Merck KGaA jointly develop and commercialize Erbitux.

In combination with the chemotherapeutic agent irinotecan, Erbitux is indicated for the treatment of EGFR-expressing, metastatic colorectal cancer (mCRC) in irinotecan-refractory patients. As a single agent, Erbitux is indicated for the treatment of mCRC in patients who are intolerant to irinotecan-based chemotherapy. However, it can cause adverse effects and is very expensive. Therefore, only colon patients who might derive benefit from its use should be treated with it.

The use of monoclonal antibody EGFR inhibitors is not recommended for the treatment of metastatic colorectal cancer in patients with mutations in codon 12 or 13 in the K-RAS oncogene. The DxS TheraScreen: K-RAS mutation kit detects K-RAS mutations in these codons. About 40% of patients with mCRC have K-RAS mutations while the majority, 60%, has the wild-type K-RAS gene. The mutation kit, if approved by the U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA), will become a companion diagnostic for use with Erbitux in mCRC to determine which patients have wild-type K-RAS status in the United States.

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.”

DxS, a personalized company, has a portfolio of cancer mutation products for diagnostic assays and research. The TheraScreen range of CE-marked in vitro diagnostic (IVD) kits identifies genetic tumor mutations that affect how patients respond to cancer therapies. DxS currently produces two diagnostic kits, TheraScreen K-RAS and TheraScreen EGFR29. Working in partnership with pharmaceutical companies, DxS supports the development and sales of targeted cancer therapies by providing biomarkers and companion diagnostics.

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