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New Releases: Jun 3, 2009

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Quest Diagnostics this week launched the EGFR Pathway Test which detects mutations in KRAS with reflex to NRAS, BRAF.

Quest is touting the product as "the first laboratory-developed test from a national commercial reference laboratory for comprehensively identifying, in a single reflex test offering, genetic mutations in the KRAS, NRAS, and BRAF genes."

According to the company, the test identifies roughly half of all metastatic colorectal cancer patients who due to certain EGFR mutations do not respond to anti-EGFR monoclonal antibody treatments for metastatic colon cancer.

"While some commercial laboratory tests for predicting anti-EGFR response analyze certain mutations of the KRAS and BRAF genes, such as codons 12 and 13 of KRAS," Quest's test detects mutations in codons 12, 13, and 61 of both the KRAS and NRAS genes and mutations in exons 11, 12, and 15 of the BRAF gene, "in a sequential reflex manner," the company said in a statement.

DxS also markets its TheraScreen KRAS Test kit in the US through Exiqon and that test detects seven mutations in codons 12 and 13. The UK personalized medicine company also sells a test kit that detects 29 of the most common somatic mutations in the EGFR gene; a T790M mutation kit comprising two RT PCR assays to detect the mutant base at position 2369 of the EGFR gene and to quantify the EGFR gene; and a BRAF test kit.

The American Society of Clinical Oncology earlier this year issued an opinion recommending that mCRC patients prior to receiving anti-EGFR therapy should first be tested for KRAS gene mutations. These mutations hamper response to anti-EGFR treatments in approximately 40 percent of colorectal cancer patients.

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