9/2/2009 2:02:23 PM
Manchester, 2 September 2009 - 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.”
Financial terms of the agreement are not disclosed.
DxS is a personalised medicine company providing molecular diagnostics to aid doctors and drug companies in selecting therapies for patients. Working in partnership with pharmaceutical companies, DxS will support the development and sales of targeted cancer therapies by providing biomarkers and companion diagnostics. Since its founding in 2001, DxS has experienced considerable growth and firmly established itself as a leader in companion diagnostics, having recently secured deals with leading healthcare companies such as Amgen, Boehringer Ingelheim and AstraZeneca. In addition, DxS has an exclusive agreement with Roche Diagnostics for the global distribution of its diagnostic products.
DxS has a portfolio of cancer mutation products including both diagnostic and assays for research use. The TheraScreen® range of CE-marked (IVD) diagnostic kits (not for sale in the U.S.) can identify genetic tumour mutations that affect how patients respond to cancer therapies. DxS currently produce two diagnostic kits, TheraScreen K-RAS and TheraScreen EGFR29. The TheraScreen: K-RAS Mutation kit is a companion diagnostic for Vectibix® (Amgen) and Erbitux® (Merck KGaA) for the treatment of colorectal cancer.
DxS is a private, venture capital-backed company operating from the heart of Manchester’s Technology Quarter in the UK.
For further information please visit www.dxsdiagnostics.com
Erbitux is a registered trademark of ImClone LLC, a wholly-owned subsidiary of Eli Lilly and Company, licensed to Bristol-Myers Squibb for commercialization in the US and Canada and to Merck KGaA, Darmstadt, Germany, for commercialization outside the US and Canada. In Japan, ImClone Systems, Bristol-Myers Squibb and Merck KGaA jointly develop and commercialize Erbitux.
TheraScreen is a registered trademark of DxS Limited.