Roche gains exclusive rights to the first test worldwide and to the second in all markets accept North America and Hong Kong.

Roche signed on to be a distributor of DxS’ TheraScreen K-RAS and EGFR 29 Mutation Tests. Roche will have exclusive, worldwide distribution rights for the K-RAS Test. For the EGFR test, Roche will be granted exclusive distribution rights for all global markets except the U.S., Canada, Mexico, and Hong Kong.

The TheraScreen K-RAS Mutation Test was, according to the companies, the first clinically validated, CE-Mark certified companion diagnostic for tumor-specific mutations in patients with colorectal cancer. The test detects seven mutations in codons 12 and 13 of the K-RAS oncogene, which are frequently found in many cancer types.

The TheraScreen EGFR 29 Test, which also has CE-Mark certification, is designed to enable detection of 29 of the most common somatic mutations in the EGFR gene and reportedly 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 EGFR gene.

These mutations may correlate with responsiveness to the EGFR tyrosine kinase inhibitors, with some mutations having a sensitizing effect and others being linked to resistance.

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