BERLIN and SEATTLE, April 21, 2008 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX), a molecular diagnostics company focusing on the development and commercialization of products for cancer based on DNA methylation, today announced that it successfully validated a technically improved assay and an enhanced testing algorithm for its colorectal cancer biomarker, Septin 9, in two independent clinical case control studies. The studies confirmed that the assay optimized for routine molecular diagnostic laboratory use detects colorectal cancer in blood plasma statistically equivalent to the previously used research assay.
The first prospective case control study (269 subjects) tested blood samples from 97 patients with, and 172 individuals without, colorectal cancer as confirmed by colonoscopy. The new assay detected 72 of 97 cancer cases (74% sensitivity) and only 14 of 172 individuals without disease (false positive rate of 8% or 92% specificity). The second case control study, composed of an entirely independent set of blood plasma samples from 249 subjects, confirmed the performance observed in the first study. In this study the new, optimized assay identified 63 of 91 colorectal cancer patients of all stages (69% sensitivity) and only 17 of 158 patients without colorectal cancer (89% specificity). In these two independent studies, the performance of the new assay was statistically equivalent to the performance of the research assay previously used in a 2006 study of over 300 subjects, which demonstrated a sensitivity of 72% at a specificity of 90%.
Detailed results of both studies will be presented by Cathy Lofton-Day, PhD, VP Molecular Biology at Epigenomics Inc., at the upcoming Biomarker World Congress 2008 in Philadelphia, PA, USA, May 19 - 21, 2008 and at the upcoming AACR special conference "Cancer Epigenetics" in Boston, MA, USA, May 28 - 31, 2008.
The improved assay marks a significant milestone towards the development and commercialization of Septin 9 DNA methylation biomarker assays, as it provides a reference for the development of Septin 9 based diagnostic products for colorectal cancer. Technical improvements of the assay used in these two studies included a simplified sample handling process and a significant shortening in handling time resulting in a doubling of sample throughput per lab technician. Most importantly, the assay costs could be reduced by 65% and the DNA extraction and the biomarker assay processing are now compatible with widely available laboratory automation solutions. Epigenomics also developed an enhanced and robust algorithm to interpret Septin 9 DNA methylation as a biomarker for colorectal cancer. These improvements position the assay for a potential application to a mass screening approach.
"We considerably simplified our Septin 9 assay, making it significantly cheaper and compatible with laboratory automation solutions. We have repeatedly demonstrated the excellent ability of the Septin 9 biomarker to detect colorectal cancer in blood plasma with high sensitivity and specificity and we found that these data are highly consistent across several independent studies. This clearly demonstrates the robustness of our DNA methylation technology and the Septin 9 biomarker which now has proven its performance in more than 3,500 patient samples," commented Geert Nygaard, Chief Executive Officer of Epigenomics.
As a next step in Epigenomics' program for the development of a blood based colorectal cancer screening test, the company aims at demonstrating that Septin 9 performance satisfies the requirements of the most recent U.S. screening guidelines for colorectal cancer and demonstrates a benefit in a validated health economic model. To this end the company plans to initiate PRESEPT, a multi-center and international study to characterize Septin 9 clinical performance and health economic benefits in a U.S. colorectal cancer screening guideline-eligible population. The study is planned to commence in Q2 2008 and will include up to 7,500 average and increased risk individuals, professional society guideline-eligible to receive screening colonoscopy.
About Colorectal Cancer Screening and the Septin 9 Biomarker
Colorectal cancer is the second leading cause of cancer related death. With a 5-year-survival rate of above 90 percent if diagnosed at an early stage, early detection through blood based testing would be valuable. This type of test targets almost 300 million people in Europe, the U.S., and Japan, a market that is worth more than US$3billion in total. The gold standard screening test is colonoscopy, an invasive procedure, whereby the physician visually inspects the inside of the colon. This procedure, which has excellent specificity and sensitivity characteristics, not only identifies cancer but also pre-cancerous lesions known as adenomas. Due to the nature of this procedure and its high cost, it is not widely used at short intervals. A non-invasive first-line test therefore would be useful to screen individuals at risk so that they then undergo colonoscopy. Currently, most non-invasive screening is carried out with the Fecal Occult Blood Testing (FOBT) procedure using stool samples. However, due to the inconvenient nature of the test, the compliance rate is comparatively low. The introduction of a more convenient, patient-friendly test could potentially increase the number of individuals tested. If positive, the patients would be followed up by colonoscopy. This could increase the chances of the disease being caught early with the goal of reducing mortality from colorectal cancer.
Epigenomics' technology aim at sensitively detecting DNA based on specific DNA methylation patterns in blood plasma samples or other body fluids. The Septin 9 gene encodes a protein involved in cell division and is thought to play a role in the onset of cancer. Epigenomics has demonstrated in multiple clinical case control studies with over 3,500 samples from colorectal cancer patients, healthy controls, and patients with non-cancerous colon diseases that methylated DNA of Septin 9 shed by tumors into the blood stream can serve as a biomarker for the sensitive and specific detection of colorectal cancer. As a first strategic partner, Abbott Molecular,Inc. licensed the worldwide non-exclusive IVD rights to Epigenomics' proprietary Septin 9 biomarker for colorectal cancer. In addition, Quest Diagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.
About DNA Methylation
DNA methylation is a natural and tightly controlled biological process that serves the regulation of genes and the stability of the human genome. Cytosine, one of the four bases in DNA, can be modified by the covalent addition of a methyl group. DNA methylation in gene regulatory regions (i.e. gene promoters) helps control gene activity. Every cell type has its unique DNA methylation "fingerprint" that changes in various normal biological processes and in many diseases,in particular cancer. DNA methylation thus provides a rich source for highly specific biomarkers for organ-specific disease diagnosis, classification and prediction for therapeutic intervention.
About Epigenomics AG
Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. Using DNA methylation biomarkers, Epigenomics' tests can potentially diagnose cancer at an early stage and thereby may reduce mortality from this dreaded disease.
The company develops diagnostic screening tests for the early detection of cancer. Based on body fluid samples (e.g. blood and urine), these tests are aimed at finding cancer at an early stage before symptoms occur. Epigenomics' product pipeline contains a validated biomarker for the early detection of colorectal cancer in blood plasma, and further proprietary DNA methylation biomarkers at various stages of development for prostate and lung cancer detection in body fluids. For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry companies. As a first strategic partner, Abbott Molecular Inc. licensed the worldwide non-exclusive IVD rights to Epigenomics' proprietary Septin 9 biomarker for colorectal cancer. Epigenomics also aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. As a first reference laboratory partner, Quest Diagnostics Inc., the leading provider of diagnostic testing, information and services, obtained the license to commercialize a laboratory-developed test (LDT) for Septin 9 in the U.S.
Partners in the health care industry and the biomedical research community can access Epigenomics' portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 150 patent families through research products, Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, U.S.A. For more information, please visit Epigenomics' website at www.epigenomics.com.
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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.