Epigenomics: Clinical studies show its diagnostic test can detect colorectal cancer from simple blood draw

By E. Janene Geiss

Philadelphia, Dec. 19 - Epigenomics AG announced Monday positive results of a series of large clinical studies, demonstrating that its molecular diagnostic test developed in collaboration with Roche Diagnostics was able to detect colorectal cancer from a standard, non-invasive blood draw.

Epigenomics believes that this diagnostic, which works by interpreting changes in DNA methylation, has the potential to support large-scale, general population colorectal cancer screening since early detection of colorectal cancer significantly improves treatment outcome, according to a company news release.

The test targets asymptomatic men and women over the age of 50 who are recommended to take an early detection test for colorectal cancer on a regular basis.

Successfully meeting this milestone led to the full payment to Epigenomics of the milestone that had been agreed in the collaboration agreement, officials said.

Roche Diagnostics now has a worldwide exclusive license to this test and will begin to transfer the marker and technologies onto Roche Diagnostics' platforms in 2006, officials said.

At a set specificity of 95%, the lead marker demonstrated sensitivity values of 51%, 65% and 50%, respectively, in three independent clinical studies, matching or surpassing the performance of the best molecular screening tests, officials said.

Importantly, early stage cancers were identified with the same sensitivity as later stage cancers, proving the utility of this approach for general population screening.

Results were obtained measuring only a single DNA methylation "anchor" marker, and the test was able to detect colorectal cancers regardless of their location, addressing a critical medical need and shortfall of the existing fecal occult blood tests, currently the most widely used screening test, officials said.

Epigenomics said it conducted the studies to identify and validate DNA methylation-based markers using blood plasma. In two of those studies, Roche had previously blinded all samples. In total, about 2,000 samples were tested comprising more than 600 plasma samples from colorectal cancer patients with a representative distribution of disease at all four stages. In addition, a comprehensive collection of 600 so-called "critical controls," representing the most likely confounding other diseases, as well as more than 600 normal controls from an age-matched, colonoscopy-verified population, were included.

"Within a few years of research, we have developed a novel technology, discovered proprietary biomarkers, and have shown clear evidence that these markers can be used for the early detection of cancer. This work provides a solid foundation for developing a broad pipeline of leading molecular diagnostics. It's really the beginning, not the culmination of Epigenomics' success story," Alexander Olek, Epigenomics' chief executive officer, said in the release.

Epigenomics is a Berlin, Germany, molecular diagnostic company with a focus on the development of novel products for cancer.

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