Epigenomics AG announced that Roche Diagnostics has notified the company about the termination of the joint collaboration focusing on the development of a range of molecular diagnostic cancer products.

Roche Diagnostics will return all rights and licenses including the first marker, Septin 9, which it had licensed in December 2005. Roche Diagnostics took the decision after the presentation of new clinical data from the colorectal cancer screening test programme.

In a prospective study on 561 blood plasma samples, Epigenomics validated that a modified sample processing workflow and a marker panel consisting of Septin 9 and one novel biomarker, improved the detection of early stage (I-III) colorectal cancer with 66 per cent sensitivity and 93 per cent specificity significantly over studies with Septin 9 alone reported in 2005.

In another study in its prostate cancer screening programme with Roche, Epigenomics detected prostate cancer with a sensitivity of up to 74 per cent at a specificity of 96 per cent using single proprietary DNA methylation biomarkers on urine samples of prostate cancer patients and healthy individuals.

Epigenomics is convinced that the quality of the new data allows the further development and commercialization of in vitro diagnostic test products for early detection of cancer. Now that Epigenomics has full control over all its product development programmes, the company will review all options for a fast commercialization of the cancer screening tests.

"Our new colorectal cancer screening data clearly exceeds expert's desired performance target for a product that could address this huge market successfully. We are disappointed about Roche's decision and strongly disagree with their impression that our data does not support a development decision". Christian Piepenbrock, COO of Epigenomics. "We as Epigenomics believe the performance of our colorectal biomarker panel warrants further development and commercialization to make patients benefit as soon as possible from this urgently needed blood test".

In September 2002, Epigenomics and Roche entered into a broad collaboration to develop a range of molecular diagnostic cancer products based on Epigenomics' DNA methylation technologies. The collaboration focused at last on the development of three in vitro diagnostic products for the early detection of colorectal, prostate, and breast cancer.

Epigenomics in all three programmes was responsible for biomarker research including discovery, selection and pre-validation of biomarker panels in clinical proof-of-concept studies. At the end of the research phase, Roche Diagnostics had the right to obtain a world wide exclusive license for the prevalidated biomarker panel and a non-exclusive license to Epigenomics' DNA methylation technology to develop and commercialize in vitro diagnostic test kits for the biomarker panels in the respective applications.

Diagnostic test development, pivotal clinical trials, product manufacturing, regulatory submissions and all sales and marketing worldwide were to be conducted by Roche.

Under the terms of the agreement, Roche made an upfront payment of EUR 4 million and in addition provided R&D funding, milestone payments and was to provide royalties on product sales. Since 2002, Epigenomics has met a series of major milestones in this collaboration, which was originally earlier this year extended by 18 months to September 2007.

Following the successful validation and subsequent licensing by Roche Diagnostics of Septin 9 as an "anchor" DNA methylation marker in December 2005, Epigenomics continued its research and development efforts to further improve the early detection of colorectal cancer (CRC) in blood.

A panel containing Septin 9 and one additional novel DNA methylation biomarker together with a modified sample processing workflow was finally validated in a clinical study with prospectively collected blood samples of 561 individuals. The study met its goals by demonstrating that early stage colorectal cancers (patients with stage I-III CRC) could be detected with 66 per cent sensitivity at 93 per cent specificity. This is an improvement of 16 percentage points in sensitivity at comparable specificity over the reference study with Septin 9 alone reported in December 2005.

The clinical study was performed on matched plasma and urine samples collected from 91 prostate cancer patients and 100 controls without cancer. Four proprietary candidate biomarkers previously identified on tissue were measured using Epigenomics sensitive DNA methylation assays.

The study met its goals by demonstrating the feasibility of detecting prostate cancer in body fluids and determined that for this cancer urine is the better analyte compared to plasma. All of the four biomarker candidates studied were able to discriminate between prostate cancer and healthy controls with sensitivities of up to 74 per cent in urine compared up to 37 per cent in plasma at a predefined specificity of 96 per cent.