The new test is based on DNA methylation of the Septin9 gene, a proprietary biomarker associated with colorectal cancer that was identified by Epigenomics AG (Frankfurt, Prime Standard: ECX), a cancer molecular diagnostics company. Quest Diagnostics is the first commercial laboratory in the U.S. to offer a laboratory-developed test based on the Septin9 biomarker.
"Early detection rates are dismally low, largely because many patients find existing tests and procedures invasive or unpleasant," said Jon R. Cohen, M.D. senior vice president and chief medical officer, Quest Diagnostics. "Our ColoVantage(TM) test, which is based on Septin9, has yet to be clinically validated as a screening test. Rather, it may promote further evaluation in patients who have resisted testing in the past or as an adjunct to existing procedures."
Colorectal cancer treated in localized, early stages has a five-year survival rate of 90 percent. Yet, only 40 percent of cases are diagnosed in early stages, due to low screening rates.
Epigenomics has demonstrated in more than a half dozen peer-reviewed studies involving approximately 3,000 specimens of patients with diagnosed colorectal cancer and of healthy control subjects that methylated Septin9 in blood plasma indicates an increased likelihood of colorectal cancer. Epigenomics is sponsoring a multi-center clinical study named PRESEPT in collaboration with Quest Diagnostics and other organizations to evaluate the Septin9 biomarker's performance for colorectal cancer screening in screening-guideline-eligible individuals who have not been diagnosed with colorectal cancer. Epigenomics expects to conclude the PRESEPT trial early this year with the release of preliminary data, and publish the detailed findings later in 2010.
Quest Diagnostics is a leader in colorectal cancer diagnostics. The company's InSure(R) fecal immunochemical test (FIT) is an FDA-cleared fecal occult blood test (FOBT) for use in screening for sources of lower gastrointestinal bleeding, based on laboratory testing of a stool-based specimen. The company also offers mutation testing to help predict if a patient with metastatic colorectal cancer will respond to certain therapies and genetic testing to aid in evaluating a patient's inherited predisposition to colorectal cancer. In addition, the company provides anatomic pathology testing services for colorectal cancer, such as biopsy testing of tissues identified through colonoscopy.
About Colorectal Cancer Testing and Procedures
Colorectal cancer, which refers to cancer of the colon and rectum, is a major source of cancer death in the U.S. and worldwide. An estimated 106,000 new cases were diagnosed and 50,000 deaths from the disease occurred in the U.S. in 2009. According to the American Cancer Society (ACS), beginning at age 50, both men and women at average risk for developing colorectal cancer should be screened by one of several established tests. People with certain risk factors, such as a family history, may be indicated for earlier or more frequent testing. Such methods include colonoscopy, the screening gold standard, once every ten years, as well as flexible sigmoidoscopy, virtual colonoscopy and double-contrast barium enema every five years or FOBTs, including FITs, annually. Any positive test result of any non-colonoscopy methods should be followed up by colonoscopy.
About Quest Diagnostics
Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics is a pioneer in developing innovative diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at http://www.questdiagnostics.com/.
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SOURCE Quest Diagnostics Incorporated