BERLIN and SEATTLE, July 29, 2008 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt Prime Standard:ECX), a molecular diagnostics company focusing on the development and commercialization of products for cancer detection based on DNA methylation, today announced that it received a Rule 71(3) notification stating that the European Patent Office intends to grant a patent for Epigenomics' Septin 9 biomarker. This notification is equivalent to a "Notice of Allowance" by the United States Patent and Trademark Office. Patent application EP 1721992, titled "Methods and nucleic acids for analyses of cellular proliferative disorders," claims very broadly methods, substances and kits for the methylation analysis of Epigenomics' Septin 9 biomarker. The patent application is also pending in the USA, Japan and 15 other countries outside of Europe.
Following the receipt of the patent allowance Geert Nygaard, Epigenomics' Chief Executive Officer, commented: "This allowance marks a major milestone in our commercial strategy and company development. The patent adds a strong layer of protection to our colorectal cancer screening product and entitles us to significant royalties in years to come from our diagnostics partnerships for this biomarker."
"Our patent protection is now not only covering our preanalytics and sensitive detection technologies such as Heavy Methyl (HM) and MethyLight proprietary, but also the core of the product, the Septin 9 biomarker, for the detection of colorectal cancer in blood," adds Dr. Kurt Berlin, Epigenomics' Chief Scientific Officer. "This is one of several dozen biomarker patent applications covering hundreds of proprietary DNA methylation biomarkers in many cancer indications. This patent portfolio underscores our leading position in molecular diagnostics based on DNA methylation."
About Colorectal Cancer Screening
Colorectal cancer is the second leading cause of cancer related death in the U.S. with an estimated direct medical treatment cost of $8.3 billion in 2007. With a cure rate over 90% if diagnosed in early stages in the United States, there is now general agreement that average-risk adults aged 50 and older should be screened for colorectal cancer. If detected early, individual treatment costs for colon cancer are estimated at $30,000 per patient, whereas treatment for a patient who has developed late stage disease is estimated at $120,000. However, less than 50% of the screening population has had a recent test. Given today's treatment options for colorectal cancer, patient outcomes could potentially be greatly improved if more cancers were detected in early stages.
However, from public health as well as health economics perspectives, the poor adoption of current screening options limits the effectiveness of colorectal cancer screening initiatives; Current colorectal cancer screening guidelines include FOBT, sigmoidoscopy (alone or with FOBT), or colonoscopy. Non-invasive screening is conducted using FOBT, which while inexpensive, exhibits a low compliance rate (around 14% in the U.S.) due to its use restrictions, perceived inconvenience and lack of consumer acceptance. The gold standard procedure for colorectal cancer detection is colonoscopy; it exhibits excellent performance characteristics, but has a limited utility as a first line screen due to its high cost, healthcare delivery resource limitations, and inadequate patient acceptance. It is believed a noninvasive, first-line screening assay capable of detecting individuals with colorectal disease, confirmed by colonoscopy, would have greater utility for population screening.
About the Septin 9 Biomarker
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 the Septin 9 gene 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 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 in development aim at diagnosing cancer at an early stage before symptoms occur and thereby may reduce mortality from this dreaded disease.
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. Epigenomics' biomarker Septin 9 for the early detection of colorectal cancer in a simple blood sample demonstrated continuously highest performance in multiple clinical studies with in total more than 3,500 individuals tested.
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.
Disclaimer
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.