Roche and DxS have signed an exclusive distribution agreement 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 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".
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.
"We are extremely pleased to have concluded this distribution agreement with Roche," said Stephen Little, CEO 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 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 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.
Recent publications have shown that the successful treatment of metastatic colorectal cancer (mCRC), using some monoclonal antibody therapies is directly linked to the oncogenic activation of the K-RAS signaling pathway.
Recently, the European Commission granted a conditional marketing authorisation for a monoclonal antibody, panitumumab, as monotherapy for the treatment of patients with wild-type K-RAS genes after failure of standard chemotherapy regimens.
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.
Recent studies into non-small cell lung cancer have shown that some patients carry somatic mutations in the epidermal growth factor receptor (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.
