Epigenomics AG, a molecular diagnostics company developing tests based on DNA methylation, has agreed to terms with Roche Diagnostics for an amendment to detail the research & development (R&D) structure of its ongoing collaboration. Under the new terms, the validation process for all candidate tests will be redesigned and expanded.

Epigenomics will increase the number of blood or tissue samples to be studied to more than 1000 per test. Each test consists of a panel of DNA methylation biomarkers, substances in the body that may indicate the presence or molecular classification of disease. By increasing the number and variation of samples against which the biomarker panels are tested, the companies believe that more robust clinical data on sensitivity and specificity and the best information allowing for the most competitive tests will be obtained at an earlier stage.

Epigenomics will receive additional R&D payments of up to €2 million for its expanded role in the collaboration, the first step of which has already been committed with the initiation of transfer to Roche of the Breast Cancer Tamoxifen Response Test, which is the first one currently undergoing this expanded process.

"Together, we have reviewed a number of technical processes involved with the validation of our tests and - as indicated already in our IPO prospectus - successfully adjusted them accordingly. With these changes, Epigenomics will play a larger role in R&D than was outlined in our original agreement," stated Gary Schweikhardt, Head of the SBU Diagnostics of Epigenomics.

Epigenomics' collaboration with Roche Diagnostics, a world leader in molecular diagnostics, involves the development of tests to diagnose prostate, colon and breast cancer; a test for molecular classification of prostate cancer; and a pharmacodiagnostic test to predict the probability of relapse in women treated with the standard breast cancer treatment, tamoxifen. The Company anticipates this clinical validation data on the colon and prostate cancer screening tests to become available from the second half of 2005 onwards.