Quest Diagnostics to Develop Blood Test to Aid in the Detection of Colorectal Cancer

Quest Diagnostics Incorporated, the leading provider of diagnostic testing, information and services, today announced that it has licensed rights to uses of the Septin 9 DNA methylation biomarker from Epigenomics AG, a cancer molecular diagnostics company, to develop a molecular-based laboratory test that can help physicians detect colorectal cancer based on a patient's blood specimen. Methylation of the Septin 9 gene is a marker in blood plasma of colorectal cancer, the second leading cause of cancer-related deaths in the U.S. The company plans to develop the test to act as a supplement to conventional methods of colorectal cancer screening, including colonoscopy and fecal occult blood tests (FOBTs).

"The availability of a simple blood test that can detect a biomarker for colorectal cancer will be a significant advance in the fight against this deadly disease, which is often curable when caught in the early stages," said Joyce G. Schwartz, M.D., vice president and chief laboratory officer, Quest Diagnostics. "Patient compliance in the U.S. with colorectal cancer screening guidelines is dismal. Too often, patients fail to undergo a colonoscopy or conduct other types of colorectal cancer screenings because they find these methods invasive, unpleasant or costly. A blood test for detecting colorectal cancer, once developed, will be a convenient option that complements other screening methods."

Quest Diagnostics is the first commercial laboratory in the U.S. to license uses of the Septin 9 biomarker from Epigenomics with the goal of commercializing a laboratory-developed blood-based test. The company's industry-leading experience in DNA methylation diagnostics includes offering methylation tests for Prader-Willi and Angelman Syndromes. Under terms of the agreement, Quest Diagnostics will have exclusive rights for an undisclosed period to develop and offer an assay based on the Epigenomics' technology. Epigenomics has demonstrated that methylated DNA of the Septin 9 gene in blood plasma indicates the presence of colorectal cancer in early stages. ⁽¹⁾

"Quest Diagnostics is an ideal diagnostic company to use our Septin 9 biomarker technology to commercialize a laboratory developed test for detecting colorectal cancer," said Geert Nygaard, chief executive officer of Epigenomics. "We selected Quest Diagnostics because they have a record of innovation in diagnostics, including development of other DNA methylation diagnostic tests. They also share our goal to develop technologies that will help physicians achieve improved health outcomes for their patients through accurate detection of early-stage colorectal cancer."

Colorectal cancer, which refers to cancer of the colon and rectum, is expected to have caused approximately 52,000 deaths in the U.S. in 2007. Patients with colorectal cancer detected in its earliest stage have a 90 percent chance of five-year survival. Although guidelines from the American Cancer Society (ACS) recommend that all men and women of average risk should begin regular screening at 50 years of age or older, a recent study found that only about one in four patients receiving Medicare received guideline-based follow-up screening between 1998 and 2004. Screening methods include colonoscopy, the screening gold standard, once every ten years, as well as flexible sigmoidoscopy, double-contrast barium enema and FOBTs.

Quest Diagnostics is the leader in cancer diagnostics, including tests for colorectal cancer. The company's InSure(R) fecal immunochemical test (FIT) is an FDA-cleared FOBT test for use in screening for sources of lower gastrointestinal bleeding, based on laboratory testing of a stool-based specimen. Additional cancer diagnostic tests offered by Quest Diagnostics include Leumeta™, a family of laboratory-developed assays that can help physicians detect and monitor biomarkers of leukemia and lymphoma using blood plasma instead of tissue extracted from painful bone-marrow biopsies. Quest Diagnostics expertise in cancer diagnostics also includes industry leading anatomic pathology testing services and 900 medical and scientific professionals.

"By adding a colorectal cancer blood test to our menu of cancer diagnostics, Quest Diagnostics will solidify its leadership as a provider of diagnostics for cancer," said Dr. Schwartz. "The combination of our InSure FIT colorectal-cancer screening kit and the blood-based colorectal cancer test we intend to develop will enable us to give physicians more options for detecting this cancer."

(1) Clinical Chemistry 54:2 (2008)