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Quest Diagnostics Introduces First Comprehensive Laboratory Test To Analyze KRAS, NRAS, and BRAF Gene Mutations in Reflex Testing Service
Date:6/1/2009

em determine more reliably whether or not to provide therapy with EGFR antagonists to the individual patient," said Dr. Maher Albitar, M.D., medical director and chief of Research and Development, Hematology and Oncology, Quest Diagnostics.

Anti-EGFR therapies are designed to impede cellular proliferation caused by activation of EGFR, but can trigger several side effects, including fatigue, skin rash, and nausea and vomiting. Up to 40 percent of patients with mCRC in the U.S. have mutations in the KRAS gene that render anti-EGFR therapy ineffective. In January 2009, the American Society of Clinical Oncology (ASCO) produced a provisional clinical opinion (PCO) recommending that all patients with mCRC who are candidates for anti-EFGR therapy be tested for KRAS gene mutations (specifically in codons 12 and 13), and that anti-EFGR antibody therapy should not be administered if mutations are found.

However, fewer than 50 percent of patients with wild-type (normal) KRAS genes respond to anti-EGFR therapy, suggesting that additional mechanisms may affect response. Studies demonstrate that in patients with mCRC, about five percent may have mutations in the NRAS gene and eight percent may have mutations in the BRAF gene, and that mutations in these genes are associated with poor anti-EGFR treatment response. In February 2009, The New England Journal of Medicine published correspondence by Dr. Albitar and his colleagues at Quest Diagnostics regarding results of a study of 572 colon cancer samples that found that 11 percent of RAS mutations would have been missed if only codons 12 and 13 of the KRAS gene had been analyzed (as recommended by ASCO's PCO), and recommended RAS mutation testing include KRAS and NRAS encompassing codon 61 in addition to codons 12 and 13.

The Quest Diagnostics EGFR Pathway Test sequentially detects mutations along the EGFR Pathway, beginning with KRAS
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SOURCE Quest Diagnostics Incorporated
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