ARUP Laboratories Applauds FDA's Decision On The Value Of KRAS-Mutation Testing In Colorectal Cancer

Main Category: Colorectal Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 05 Aug 2009 - 0:00 PDT

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ARUP Laboratories, a national clinical and anatomic pathology reference laboratory and a leader in innovative laboratory research and development, supports the U.S. Food and Drug Administration's (FDA) decision to put KRAS on the label of two targeted drugs, Vectibix (panitumumab) and Erbitux (cetuximab). On July 17, 2009, the FDA noted that, "retrospective analyses of metastatic colorectal cancer trials have not shown a treatment benefit for Erbitux/Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13," and that the use of the drugs is not recommended for the treatment of colorectal cancer patients with these mutations.

ARUP offers leading-edge KRAS mutation-detection testing in colon-cancer patients which can identify nearly all of the patients who will not benefit from taking either Vectibix or Erbitux. These drugs cost tens of thousands of dollars per course of therapy and simply running ARUP's KRAS mutation-detection test can potentially eliminate ineffective patient treatment and decrease health care expenses. ARUP's technical bulletin, "KRAS Mutation Detection in Colorectal Cancer; For Determining Mutational Status that Confers Resistance to Anti-EGFR Therapy"

"In the United States, colorectal cancer is the third most common form of cancer and individuals have a 6 percent lifetime risk of developing this disease," said Executive Vice President of Corporate Communications Ronald L. Weiss, MD, MBA. "Our goal is to help our clients improve patient care as well as reduce unnecessary expenditures by promoting the benefits of KRAS testing."

KRAS mutation-detection assays test colorectal cancer to determine whether a particular therapeutic strategy should be used by oncologists. Most colorectal cancer is caused by somatic mutations and is not hereditary. Mutations in the oncogene KRAS are seen in over 40 percent of sporadic colorectal cancers. While several laboratories in the United States offer this test, ARUP Laboratories' KRAS assay detects all 12 mutations at codons 12 and 13; another highly publicized assay on the market detects only seven.

KRAS mutation-detection testing is just one example of how ARUP Laboratories can partner with laboratories and hospitals to improve patient care and decrease overall health care costs by helping reduce over-, under-, and misuse of laboratory tests.

About ARUP Laboratories

ARUP Laboratories is a national clinical and anatomic pathology reference laboratory and an enterprise of the University of Utah and its Department of Pathology. With more than 2,600 employees, ARUP offers in excess of 2,000 tests and test combinations, ranging from routine screening tests to highly esoteric molecular and genetic assays, for patients nationwide. Rather than competing with its clients for physician office business, ARUP chooses instead to support clients' existing test menus by offering highly complex and unique tests, with accompanying consultative support, to enhance their abilities to provide local and regional laboratory services. ARUP's clients include more than half of the nation's university teaching hospitals and children's hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and government facilities, and major clinics. ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Clinical & Experimental Pathology(R)..

Source: ARUP Laboratories

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