Study provides clinical evidence for CE-marking in Europe and paves way to US pivotal clinical trial for submission to FDA before year-end
Berlin, Germany, and Seattle, WA, USA
Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostics company, today reported positive results in a clinical study for the Company’s second generation blood-based test for the early detection of colorectal cancer, Epi proColon® 2.0.
In the study, 98 patients with colorectal cancer and 149 patients with no evidence of disease as verified by colonoscopy were tested with the Epi proColon® 2.0 test. The test identified 95% of the cancer cases (i.e. 95% sensitivity) at a specificity of 85%. Most importantly, for stage I and II cancer where therapeutic interventions have the greatest likelihood of curing the patient from the disease, the combined sensitivity was 91%. These results demonstrate a very significant improvement over the performance of the first generation Epi proColon® test, currently marketed in Europe. In the product validation study conducted with this product in 2009, 67% of the cancer cases were detected at comparable specificity.
The new study is the first of two studies by Epigenomics to clinically validate the newly developed test. It provides the clinical evidence required for CE-marking of Epi proColon® 2.0 for launch in the European market later this year. Further, it paves the way for the second validation study that is required for a submission of the test to the U.S. Food and Drug Administration (FDA). This pivotal clinical trial will be conducted at three external laboratories, which will test a subset of blood samples from a prospectively collected cohort of about 8,000 subjects. The study is expected to be initiated and completed in time for a submission to FDA before year-end 2011.
Geert Nygaard, Chief Executive Officer of Epigenomics commented:
“In this extremely positive study, Epi proColon® 2.0 has now demonstrated a clinical performance that is unmatched by other non-invasive tests for colorectal cancer early detection. With the recent refocusing of the Company, we made a strong commitment to bring our second generation colorectal cancer blood test to the European and U.S. market and we have now delivered an important first part of our promise. We will launch the new product in Europe in the fourth quarter and we have already made preparations to start the U.S. pivotal clinical trial in the coming weeks. We are confident that we can keep our timeline of a submission to the FDA before year end.”
Epi proColon® 2.0 has a significantly enhanced performance over the first generation Epi proColon® test and also features a number of other improvements that should facilitate its use in the diagnostic routine in different regulatory environments including the U.S. For example, the test includes the use of cGMP manufactured reagents and instrumentation, fewer reagents and simplified handling, and improved automation capabilities along with the added feature that Epi proColon® 2.0 results can be obtained within a typical laboratory work shift of 8 hours compared to the two day workflow required by the first test generation.
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Epigenomics is a molecular diagnostics company developing and commercializing a pipeline of proprietary products for cancer. The Company’s products enable doctors to diagnose cancer earlier and more accurately, leading to improved outcomes for patients. Epigenomics’ lead product, Epi proColon®, is a blood-based test for the early detection of colorectal cancer, which is currently marketed in Europe and is in development for the U.S.A. The Company’s technology and products have been validated through multiple partnerships with leading global diagnostic companies including Abbott, QIAGEN, Sysmex, and Quest Diagnostics. Epigenomics is an international company with operations in Europe and the U.S.A.
Epigenomics legal disclaimers. This communication expressly or implicitly contains certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Epigenomics AG is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. The information contained in this communication does not constitute nor imply an offer to sell or transfer any product, and no product based on this technology is currently available for sale by Epigenomics in the United States or Canada. The analytical and clinical performance characteristics of any Epigenomics product based on this technology which may be sold at some future time in the U.S. have not been established.