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 CEO 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 United States, Canada, Mexico, and Hong Kong.
The TheraScreen K-RAS Mutation Test was the first clinically validated, CE-Mark certified companion diagnostic for tumor-specific mutations that are an indication of disease prognosis 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 can detect 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.