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News

Roche and DxS signs distribution deal for cancer mutation tests

Roche Molecular Diagnostics : 03 June, 2008  (Company News)
Roche have signed an exclusive distribution agreement with DxS for the DxS TheraScreen K-RAS Mutation Test and TheraScreen EGFR 29 Mutation Test.
The tests are intended, when considered with other clinically relevant factors, to aid doctors in identifying suitable patients likely to benefit from a specific cancer therapy based on their mutation status.

'There is a growing demand for tests to indicate disease prognosis and identify patient groups more likely to benefit from a particular drug,' said Daniel O'Day, president and chief executive officer of Roche Molecular Diagnostics. 'Through our partnership with DxS, we can leverage our extensive global infrastructure and commercial reach to provide these tests, which have the potential to improve treatment outcome in some patients.'

Under the terms of the agreement, Roche is granted exclusive world-wide distribution rights for the K-RAS Test, which has CE Mark certification in Europe. For the EGFR test, which also has CE Mark certification, Roche is granted exclusive distribution rights for all global markets except the USA, Canada, Mexico, and Hong Kong.

'We are extremely pleased to have concluded this distribution agreement with Roche,' said Dr Stephen Little, chief executive officer of DxS. 'Not only does it enable us to meet the growing demand for these tests, but also gives doctors and patients access to standardised test results that provide further information to enhance treatment decisions.'

The TheraScreen K-RAS Mutation Test was the first clinically validated, CE-Mark certified companion diagnostic for tumour-specific mutations in patients with colorectal cancer. In addition, some drugs used to treat colorectal and other cancers are only indicated for patients who have a non- mutated (or ‘wild-type’) K-RAS gene. The test detects seven mutations in codons 12 and 13 of the K-RAS oncogene, which are frequently found in many cancer types. These mutations are common in colorectal cancer, pancreatic cancer, lung adenocarcinoma, gall bladder cancer, bile duct cancer and thyroid cancer.

The TheraScreen EGFR 29 Test is designed to enable detection of 29 of the most common somatic mutations in the EGFR gene and detects mutations with greater sensitivity than sequencing.

Recent studies in non-small cell lung cancer have shown that some patients carry somatic mutations in the epidermal growth factor receptor (EGFR) gene. These mutations may correlate with responsiveness to the EGFR tyrosine kinase inhibitors, with some mutations having a sensitising effect and others being linked to resistance.

Ongoing trials in metastatic NSCLC are investigating whether such a test could aid doctors in selecting lung cancer patients suitable for first line treatment with EGFR tyrosine kinase inhibitors, such as Tarceva, in the future.

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