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

Quest Diagnostics Incorporated has 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 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.

"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."

Quest Diagnostics is the leader in cancer diagnostics, including tests for colorectal cancer. The company's InSure® 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.