New blood test to identify changes in DNA linked with colorectal cancer now available in the U.S.

Jan 12 2010

A new blood test that identifies changes in DNA associated with colorectal cancer is now available in the U.S. through Quest Diagnostics Incorporated (NYSE: DGX), the world's leading cancer diagnostics company. The test is designed to aid the detection of colorectal cancer, the third leading cause of cancer-related deaths.

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.