-- Technical study met its objectives
-- Considerable improvements in simplicity, processing time, costs, and
automation potential
-- Epigenomics most advanced program, a colorectal cancer screening test,
now ready for planned reference laboratory transfer
-- Basis for future IVD test kit development together with diagnostic
industry partners
BERLIN and SEATTLE, July 3, 2007 (PRIME NEWSWIRE) -- Epigenomics AG (Frankfurt:ECX) (Prime Standard: ECX) has reached a milestone in completing the work on an optimized assay procedure for its blood-based cancer screening tests. The most advanced of these, the colorectal cancer screening test, is now ready for its planned reference laboratory transfer.
After having demonstrated the performance of its biomarker Septin 9 for the convenient and reliable detection of colorectal cancer in blood plasma in December 2006, Epigenomics had focused on the improvement of the assay procedure used to process the patient blood plasma samples and measure the biomarker. In four projects, Epigenomics worked systematically on all major steps of its research workflow to develop an improved assay procedure compatible with routine clinical use and automation. In a technical study, the company tested each improvement separately and their overall combined impact, and demonstrated now that the optimized assay procedure analytically performs equally or better to the previously used research workflow.
Improvements included a simplified sample handling, reduction in the costs of goods by more than 70% and a considerable shortening of the total processing time. In addition the throughput of patient samples that can be processed in parallel by a lab technician was doubled. Most importantly, DNA extraction and the biomarker assay are now compatible with widely available laboratory automation solutions. This allows further increasing of throughput for mass screening applications.
The assay procedure could now be applied to routine clinical use and is now ready for its planned transfer into a reference laboratory to establish a commercial testing service for Epigenomics' proprietary colorectal cancer early detection biomarker Septin 9. The modified assay procedure also marks a milestone towards the planned development of an in vitro diagnostic (IVD) test kit for automated molecular diagnostics platforms of potential diagnostic industry partners that want to commercialize Epigenomics' colorectal cancer screening test broadly.
"We took a very systematic approach to optimize all major steps of our assay procedure for blood-based screening tests based on the requirements for reference laboratory use and IVD test kit development. We are very pleased that our study met all its objectives and we have now established a workflow that is simpler, cheaper, and quicker than our previous one and works for high-throughput applications such as our colorectal, prostate and lung cancer screening tests in development," said Christian Piepenbrock, Chief Operating Officer of Epigenomics.
"Beginning of 2007 we set ourselves the goal of establishing an optimized assay procedure. We reached this goal on time and the positive results of this effort enable us to continue our work on both, our cancer screening test development programs as well as our partnering based commercialization strategy as planned," commented Geert Nygaard, Chief Executive Officer of Epigenomics.
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 disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics' defined business strategy covers two complementary core business areas:
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 panel 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 aims at giving patients and doctors early access to these biomarkers through reference laboratory testing services. For development and global commercialization as in vitro diagnostic test kits, Epigenomics pursues a non-exclusive partnering strategy with diagnostics industry players.
As a second core business area, Epigenomics develops specialty diagnostics for individuals at high risk for cancer and cancer patients. These tests include surveillance applications of our colorectal cancer biomarkers and a tissue-based prognostic cancer molecular classification test for prostate cancer patients. Our tissue-based prostate cancer application is developed in strategic partnerships with Qiagen (pre-analytics) and Affymetrix (diagnostic device platform). The biomarkers for cancer specialty diagnostic applications will be made available through testing services in centralized reference laboratories. Epigenomics retains the flexibility to decide on further commercialization as in vitro diagnostic test kits in Europe.
Pharma, diagnostics and biotech partners can access Epigenomics' portfolio of proprietary DNA methylation technologies and biomarkers protected by more than 190 patent families through Biomarker Services, IVD Development Collaborations, and Licensing. The company is headquartered in Berlin, Germany, and has a wholly owned subsidiary in Seattle, WA, USA. 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.