Company will work with ImClone and BMS to develop FDA-approved test for mCRC patients.
DxS is to work with ImClone Systems and Bristol-Myers Squibb on the development of a companion diagnostic for the anticancer drug Erbitux® in North America. The test will be based on DxS’ TheraScreen® K-RAS mutation kit.
If approved by FDA, the kit, which detects multiple mutations in codons 12 and 13 of the K-RAS gene, would be used to determine which patients with metastatic colorectal cancer patients are suitable for treatment with Erbitux. The company points out that about 60% of metastatic colorectal cancer patients have a wild-type (nonmutated) K-RAS gene, and it is these patients who are suited to anti-EGFR therapies.
In July the Canadian regulatory authorities approved the TheraScreen: K-RAS Mutation Kit for use as a diagnostic for anti-EGFR therapies and specifically as the companion diagnostic for Amgen’s colorectal cancer therapy, Vectibix™. In March DxS confirmed receipt of CE Mark certification for the same kit used on the Roche’s LightCycler® 480 Instrument II.
In July DxS signed an agreement with AstraZeneca for development of a TheraScreen EGFR29 Mutation Kit as a companion diagnostic for the non-small-cell lung cancer (NSCLC) therapy Iressa. The kit, which detects 29 of the most common somatic mutations in the EGFR gene, was granted a CE mark in 2007. Both the
TheraScreen K-RAS and TheraScreen EGFR29 Mutation kits are based on a real-time PCR format combining DxS’s Scorpions® and ARMS® (allele specific PCR) technologies.