New Test Informs Colorectal Cancer Therapy Choices

16 Dec 2011
Sonia Nicholas
Managing Editor and Clinical Lead

Randox has announced the release of a new molecular diagnostic test for detecting point mutations in KRAS, BRAF and PIK3CA genes. The KRAS/BRAF/PIK3CA Array allows clinicians to select appropriate patients for anti-EGFR therapy, maximising drug efficacy and minimising adverse side effects to the patient.

Despite recent therapeutic advances, the prognosis for metastatic Colorectal Cancer (mCRC) remains poor. Early diagnosis and assignment of the most appropriate therapy pathway is crucial in allowing the correct treatment to be commenced as quickly as possible.

Monoclonal antibodies (MoAbs) which target the epidermal growth receptor (EGFR) have been proven to be effective as single agents, or in combination with chemotherapy for treatment of mCRC. However, only a subset of patients with mCRC will benefit from EGFR-targeted MoAbs.

Mutations in the KRAS gene are known to disrupt the EGFR pathway, rendering the anti-EGFR therapy ineffective. These mutations account for approximately 35-45% of non-responsive patients. Mutations in the BRAF and PIK3CA genes have also been reported to affect patient response to EGFR-targeted MoAbs.

The KRAS/BRAF/PIK3CA Array is designed for the rapid qualitative detection of point mutations within the genes KRAS, BRAF and PIK3CA from tissue DNA. The array offers a streamlined workflow, with the protocol and reagents specially optimised for the molecular laboratory and is compatible for use with a range of genomic DNA input and type including; cell lines, FFPE tissue and fresh/frozen tissue. A single DNA sample is required for testing, with results obtained in three hours. The technique of a single reaction multiplex coupled to a biochip provides greater mutation coverage of the three most important genes (KRAS, BRAF and PIK3CA) implicated in metastatic colorectal cancer therapy response. With three internal controls on each individual biochip, results are reliable.

The KRAS/BRAF/PIK3CA Array from Randox offers a rapid, reliable and simple method of selecting patients who are more likely to respond to anti-EGFR therapy, thereby allowing correct treatment to begin early, avoiding extra costs and adverse side effects associated with administering ineffective treatment.

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