Roche Distributes Companion Diagnostics for Tumor-Specific Mutations

Under the terms of the agreement, Roche was granted exclusive worldwide distribution rights for the K-RAS test, which has Conformité Européene (CE) marking certification in Europe. For the EGFR test, which also has CE Marking certification, Roche was granted exclusive distribution rights for all global markets except the United States, Canada, Mexico, and Hong Kong.

The TheraScreen K-RAS mutation test is a companion diagnostic for tumor-specific mutations that indicate disease prognosis in patients with colorectal cancer. 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 aid doctors in selecting lung cancer patients suitable for treatment with some of the tyrosine kinase-inhibitor therapies. It enables detection of 29 of the most common somatic mutations in the EGFR gene and detects mutations not visible by sequencing. Some patients suffering from non-small cell lung cancer carry somatic mutations in the EGFR gene. These mutations correlate with responsiveness to the tyrosine kinase-inhibitor gefitinib, with some mutations having a sensitizing effect and others being linked to resistance.

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


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