GEN Exclusives

More »

GEN News Highlights

More »
Sep 2, 2009

DxS to Develop K-RAS Mutation Kit as Companion Diagnostic to Erbitux

  • 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.

     



Related content

Jobs

GEN Jobs powered by HireLifeScience.com connects you directly to employers in pharma, biotech, and the life sciences. View 40 to 50 fresh job postings daily or search for employment opportunities including those in R&D, clinical research, QA/QC, biomanufacturing, and regulatory affairs.
 Searching...
More »

GEN Poll

More » Poll Results »

Alzheimer's Therapies

Do you think an effective treatment for Alzheimer’s will be found within the next 10–15 years?