Epigenomics reports Tamoxifen treatment response test study results inconclusive

01-Nov-2005

Epigenomics AG announced 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.

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