Strong feasibility study data for improved product concept with 91% sensitivity and 87% specificity – FDA sets February date for Pre-IDE meeting
13.01.2011 | 110113_Press_release_Epi_proColon-Product_USA
Berlin, Germany, and Seattle, WA, USA
Epigenomics AG (Frankfurt Prime Standard: ECX), the cancer molecular diagnostic company, today announced that it has concluded the feasibility phase in the development of an improved product concept for Epi proColon, the Company’s DNA methylation-based blood test for assistance in the detection of individuals with colorectal cancer. This improved product concept is being developed for the US market and as a second generation product for the European and other markets. At the same time, the FDA has set a date in February for a Pre-IDE meeting to discuss with Epigenomics the product concept, its intended use and the clinical data required to support an application for marketing of the product in the US.
Epi proColon is currently marketed in Europe and a number of other countries outside the USA and its utility in the early detection of colorectal cancer in a blood draw is extensively supported by numerous clinical studies. While the new assay measures the same epigenetic information in the Septin9 gene, design changes have been implemented that are based on the findings in the more recent studies performed by Epigenomics and its partners as well as feedback from current customers in Europe and market surveys in the US. The new device will use reagents manufactured under the cGMP standard and a real-time PCR platform that has previously been cleared by the FDA for use with diagnostic assays. Performing the assay will require fewer components and handling steps and results can be obtained within a typical laboratory work shift of 8 hours. Further, the new assay will have improved automation capabilities.
In a feasibility study that included 97 colorectal cancer patients and 159 colonoscopy-confirmed controls in the improved assay had a sensitivity for cancer of 91% at 87% specificity. In this study, the test was able to identify 21 out of 27 Stage I cancer cases (78%) and 25 out of 25 Stage II cancer cases (100%). This is particularly important as patients with Stage I and II of colorectal cancer have a combined five year survival of about 90% and early clinical interventions are effective in improving survival.
Dr. Uwe Staub, Senior Vice President Product Development at Epigenomics said: “The excellent results of this feasibility study are a direct reflection of the improvements we have made to the test. Following our upcoming dialogue with the FDA, we hope to be able to finalize our clinical validation plan for the intended use of the improved test and later this year run the pivotal study using the samples already collected as part of the prospectively enrolled PRESEPT cohort. It should be noted that the higher proportion of pT1 subgroup of Stage I cases may mean that the sensitivity in a prospective evaluation would not be as high as we have just seen in the feasibility study.”
Geert Nygaard, Chief Executive Officer of Epigenomics added: “We are delighted to have this confirmation that the improvements and adaptations we made to the assay should result in a product that meets USFDA as well as European regulatory and market requirements but also shows potentially improved clinical performance. We are looking forward to our upcoming discussions with the FDA, which commence shortly. Once those discussions conclude in the period following our face-to-face meeting we will be in the position to provide more detail on the next steps towards launching our Epi proColon test in the US.”
The Company also intends to make the improved next generation Epi proColon product available in Europe and other markets once it has been adapted to the LightCycler 480 as well as the AB7500 instruments currently used in these markets. The second generation product is likely to reach these markets by during the second half of 2011.
Contact Epigenomics AG
Epigenomics AG is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics’ tests on the market and in development for colorectal, lung, and prostate cancer aim at aiding in an earlier and more accurate diagnosis of these diseases, thereby potentially increasing the patient’s chances of survival.
For development and global commercialization of IVD test products, Epigenomics pursues a dual business strategy in which direct commercialization of proprietary diagnostic test products is combined with non-exclusive licensing to diagnostic industry players with broad customer access. Strategic diagnostics industry partners include Abbott Molecular, Sysmex Corporation, Quest Diagnostics Incorporated, ARUP Laboratories, Inc., and Warnex Laboratories, Inc. for diagnostics test products and services, and QIAGEN N.V. for sample preparation solutions and research products. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary, Epigenomics Inc., in Seattle, WA, USA. For more information, please visit Epigenomics’ website at www.epigenomics.com.
About Epi proColon
Epi proColon, developed by Epigenomics, is a test for the detection of methylated DNA of the Septin9 gene in blood plasma. Detection of this Septin9 biomarker in blood plasma has been shown in numerous clinical studies to be closely associated with the presence of colorectal cancer and may aid in the detection of this common cancer. Septin9 is one of the best and most systematically validated biomarkers for the early detection of colorectal cancer today. In particular, the recent PRESEPT Study was a successful prospective evaluation of Epi proColon detection of methylated Septin9 in a cohort of about 8,000 individuals representative of a typical screening population.
Lack of patient adherence to screening recommendations is the biggest hurdle to an effective screening for colorectal cancer. Experts believe that a blood test that is more convenient for the patients than stool tests and colonoscopy could help to get more people screened and thus be of medical and health economic benefit.
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