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Published on 4/3/2006 in the Prospect News Biotech Daily.

Epigenomics data confirms DNA screening key to early detection of colorectal cancer

By Lisa Kerner

Erie, Pa., April 3 - Epigenomics AG said it confirmed that free-floating DNA gleaned from blood is a key to early detection of colorectal cancer.

The company presented study data showing the presence of the methylated form of DNA encoding the Septin 9 gene is found in plasma of up to 57% of patients with all stages of colorectal cancer at high levels of specificity (95%).

Epigenomics presented the data at the 97th American Association of Cancer Research in Washington D.C., according to a company news release.

"The presence of methylated Septin 9 DNA in blood is a marker suited as an excellent population screening tool to identify a large number of asymptomatic cancers," vice president, molecular biology Catherine Lofton-Day said in the release.

"Our study is the first of this magnitude and with this level of clinical performance to describe a DNA methylation-based blood test for the early detection of colorectal cancer. A blood-based screening assay will be more patient-friendly than the conventional colorectal cancer screening tool, which requires patients to collect and submit fecal samples for fecal occult blood testing - a considerable obstacle to patient compliance."

The data presented come from two independent studies that determined Septin 9 levels in a total of 1,500 patients in three categories, the company said.

After validating the Septin 9 assay among the three known-status groups in a set of several hundred samples, Lofton-Day and her colleagues predicted the diagnosis of colorectal cancer in an independent set of 790 patients.

"Different stages of colorectal cancers were detected with similar sensitivity, and detection was not affected by location of the tumor in the colon," Lofton-Day added. "This is a reliable, non-invasive method to detect many patients with colorectal cancer, but who show little or no symptoms."

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


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