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Epigenomics to Launch IVD for Early Detection of Colorectal Cancer in US and Europe in 4Q

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By Turna Ray

Epigenomics this week announced it will begin marketing Epi proColon, an in vitro diagnostic blood test for the early detection of colorectal cancer, in Europe and the US in the fourth quarter of this year.

The Berlin-based company is planning to market the test in Germany, Switzerland, and Austria. Epigenomics will partner with distributors Abbott Molecular and Quest Diagnostics to launch the test in other European countries as well as the US.

Epigenomics licensed the Septin 9 biomarker to Quest in 2008 and to Abbott in 2007. Quest will likely offer the homebrew version of the test and Abbott will market the kit version [see PGx Reporter 02-27-2008].

Epi proColon is CE-marked in Europe. The company has yet to announce plans to clear the test with the US Food and Drug Administration.

Additional partners providing diagnostics services for the Epi proColon test include ARUP Laboratories and Sysmex Corporation in Japan. Qiagen is providing sample preparation solutions and research products.

Epi proColon gauges the presence of cancer from tumor-derived methylated DNA of the Septin9 gene (mSEPT9) in blood samples. Epigenomics has studied the association of mSEPT9 with colorectal cancer in seven clinical trials in more than 3,000 subjects between 2005 and 2008.

In these studies, mSEPT9 testing detected about 70 percent of the cancers across all disease stages with about 90 percent specificity, the company said in a statement.

The clinical and analytical validity of the test was confirmed in a study involving 260 participants with and without colorectal cancer. Epi proColon test detected two thirds of the cancer cases in early, still localized disease stages, Epigenomics said in a statement.

If treated while colorectal cancer is in the localized stage, and has not spread to the lymph nodes or metastasized to other organs, patients have a 90-percent survival rate.

Epigenomics’ blood-based tests offer a less-invasive option for colorectal cancer screening over more invasive colonoscopies.

“A blood test for colorectal cancer early detection that can easily be integrated into an annual health check-up and does not require patient involvement is believed to be more acceptable to doctors and patients and has the potential to greatly increase the effectiveness of national screening programs by increasing overall screening compliance,” Epigenomics said in a statement. “If tested positive in such an easy-to-use blood test, patients would be referred to a gastroenterologist for colonoscopy to confirm the diagnosis and initiate early treatment.”

According to Epigenomics, its Epi proColon test improves cancer detection over standard guaiac fecal occult blood tests. While Epi proColon has shown a 70 percent cancer detection rate in studies, guaiac FOBTs find between 30 percent and 40 percent of cancers, the company estimates.

The American Cancer Society recommends that all men and women at 50 years or older with an “average risk” of developing the disease should be screened regularly. However, a study cited by Epigenomics found that only about one in four patients receiving Medicare received guideline-based follow-up screening between 1998 and 2004.