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GEN News Highlights : Oct 6, 2009

Epigenomics Provides CE-Marked IVD Blood Test for Colorectal Cancer

Company also has a lung cancer test in development.

Epigenomics confirmed the European launch of Epi proColon, reportedly the first CE-marked IVD blood test for detecting colorectal cancer. The company plans to commercialize Epi proColon through direct marketing in Germany, Switzerland, and Austria and through distributors in the rest of Europe.

Epi proColon detects tumor-derived methylated septin9 gene (mSEPT9) DNA in blood plasma. Epigenomics says that in final performance studies involving 260 patients, the test detected two-third of colorectal cancer at early, localized, and curable stages.

Prior to launch of Epi proColon, a number of early adopter laboratories had been offering validated laboratory tests for the mSEPT9 biomarker. Launch of the CE-marked test will allow the rollout of blood-based colorectal cancer testing across molecular diagnostic laboratories in Europe.

The company points out that although routine screening for colorectal cancer is recommended in many countries, lack of convenience and the invasiveness of fecal occult blood tests and colonoscopy lead to low uptake of screening programs. It believes a simple blood test would be more easily incorporated into an annual health check. Patients testing positive using Epi proColon could then be referred for colonoscopy.

Epigenomics is also developing a lung cancer IVD, Epi proLung, which it hopes to launch during the first half of 2010. Epi proLung measures the tumor marker mSHOX2 in bronchial lavage samples.