New Molecular Diagnostic Test from Randox

Monoclonal antibodies (MoAbs) targeting the epidermal growth receptor (EGFR) have proven effective in combination with chemotherapy or as single agents for treatment of mCRC 3,4. However, only a subset of patients with mCRC clinically benefit from EGFR-targeted moAbs.

Mutations in the KRAS gene are known to disrupt the EGFR pathway, rendering the anti-EGFR therapy ineffective. Presence of KRAS mutations accounts for approximately 35-45% of non-responsive patients5. Oncogenic mutations in genes encoding key downstream effectors within the EGFR signalling pathways may also be responsible for resistance to EGFR-targeted moAbs5. Mutations within the BRAF6 and PIK3CA7 genes have now 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 administrating ineffective treatment.