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Quest Licenses Epigenomics’ Methylation Marker to Develop Blood-Based CRC Test

NEW YORK (GenomeWeb News) - Quest Diagnostics has signed a non-exclusive licensing agreement for Epigenomics’ Septin 9 DNA methylation biomarker with the goal of commercializing a laboratory-developed blood test for colorectal cancer, Epigenomics said today.
Epigenomics said that it has demonstrated in “multiple clinical case control studies” with about 3,000 blood samples that methylated DNA of the Septin 9 gene in blood plasma indicates the presence of early-stage colorectal cancer.
Quest plans to develop a Septin 9-based test as a supplement to conventional methods of colorectal cancer screening, including colonoscopy and fecal occult blood tests.
Joyce Schwartz, vice president and chief laboratory officer at Quest, said in a statement that patient compliance with colorectal cancer screening guidelines in the US is currently “dismal.” Often, she said, “patients fail to undergo a colonoscopy or conduct other types of colorectal cancer screenings because they find these methods invasive, unpleasant, or costly.”
She added that a blood test for detecting colorectal cancer would be “a convenient option that complements other screening methods."
Epigenomics said that because Quest is the first US commercial lab to license the Septin 9 marker, the company has granted it exclusivity in the US market for an undisclosed period. In return, Epigenomics will receive upfront and milestone payments as well as royalties on sales of the Septin 9-based tests.
Additional terms of the agreement were not disclosed.
Quest already offers DNA methylation diagnostics for Prader-Willi syndrome and Angelman syndrome.
Epigenomics signed a licensing agreement for the Septin 9 marker with Abbott Molecular in September 2007 covering the development of an in vitro diagnostic blood test for early detection of colorectal cancer.
Abbott and Epigenomics plan to launch a CE-marked Septin 9 IVD in Europe in 2009, and plan to file for approval with the US Food and Drug Administration in 2010.

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