BERLIN, Germany and SEATTLE, Oct. 31, 2005 (PRIMEZONE) -- Epigenomics AG (Frankfurt, Prime Standard: ECX), a molecular diagnostics company developing tests based on DNA methylation, announced today that following the timely completion of a blinded test study for its Tamoxifen treatment response test, the candidate markers could not be independently validated for technical reasons. The Tamoxifen treatment response test is being developed to predict the probability of disease recurrence in breast cancer patients.
Initial analysis of the data strongly points towards issues with the technical protocols followed rather than problems with the markers themselves. In addition, the collected data shows irregularities with sample quality and input DNA concentrations which led to an unusually high rate of sample exclusions. The markers were observed when samples with low concentrations of input DNA were excluded. A body of strong clinical data strengthens this notion as the PITX2 marker used in the test has previously been identified and validated in a number of independent studies totalling approximately 1200 patients.
Epigenomics and partner Roche Diagnostics are jointly conducting data analysis and additional experimenents. Epigenomics expects to need no more than a few months to investigate the technical issues and then successfully run a further study within another 6 to 9 months to resolve the situation. Roche Diagnostics has an option to license the Tamoxifen treatment response test as part of its multi diagnostic product development collaboration with Epigenomics.
About Epigenomics
Epigenomics is a molecular diagnostics company with a focus on the development of novel products for cancer. By detecting and interpreting DNA methylation patterns, Epigenomics' tests can potentially diagnose disease at an early stage and help guide physicians to select an appropriate therapy. Epigenomics collaborates with Roche Diagnostics on the development of several diagnostic products in cancer. The company has its headquarters in Berlin, Germany, and a wholly owned subsidiary in Seattle, USA. For more information, please visit our website at www.epigenomics.com.
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