Markers to be included in two tissue-based tests predicting disease recurrence
Epigenomics AG (Frankfurt, Prime Standard: ECX), a molecular diagnostics company developing tests based on DNA methylation, announced today that it has presented positive results from studies evaluating the prognostic value of specific biomarkers incorporated into its prostate cancer biopsy and breast cancer outcome tissue-based disease prediction tests. The data were presented as part of the 96th Annual Meeting of the American Association for Cancer Research (AACR) in Anaheim, California, USA.
"When presented with a cancer diagnosis, the physician must decide on the best course of treatment for the patient. A molecular test that is able to show how aggressive the cancer is growing would provide invaluable information as the physician considers potential treatment options," stated Alexander Olek, CEO of Epigenomics. "These studies, validating our DNA methylation markers, have provided us with significantly more information than previously expected. We believe they show significant potential for prognostic evaluation and treatment planning in prostate and breast cancer patients."
Following a genome-wide discovery effort, more than 400 candidate markers were found that were aberrantly methylated in aggressive prostate cancer (defined by early PSA recurrence, high Gleason grade or late stage). The methylation of a subset of these candidate markers was measured in DNA extracted from 330 frozen prostatectomy samples. Methylation of samples from patients whose PSA started to rise again less than two years after surgery were compared to methylation levels in patients where this did not occur. The markers were also compared with traditional prognostic indicators such as Gleason grade, stage and PSA. The studies were conducted by Epigenomics in collaboration with scientists at University Hospital Charité, Berlin, Germany and the University of Muenster, Muenster, Germany.
The studies showed that methylation of three candidate markers significantly distinguished between early recurrence and non-recurrence samples. A higher level of methylation of all three markers was found in samples from patients that experienced early recurrence. Although methylation was also found to correlate with Gleason grade, a widely used prognostic indicator for prostate cancer, methylation provided additional information beyond the Gleason score. For example, methylation levels predicted PSA recurrence even in a group of patients who all had tumors with a Gleason score of 7, and for whom Gleason score was not useful for predicting recurrence.
In breast cancer, Epigenomics has developed diagnostic assays incorporating PITX2 and other promising DNA methylation markers to identify those patients that would have an excellent clinical outcome following the treatment with Tamoxifen. The results presented at AACR by Epigenomics and investigators from Erasmus Medical Center, The Netherlands, and Technical University Munich, Munich, Germany, further validate the candidate marker PITX2 in samples from an independent cohort of 415 patients with node-negative, hormone receptor-positive breast cancer. The patients had never received any adjuvant systemic treatment and were followed for an average of 93 months.
The study confirmed that DNA methylation of PITX2 was significantly associated with the risk of disease recurrence (p< 0.001). In the group of patients with low levels of PITX2 methylation, 86% were still metastasis-free at 10 years compared to only 67% in patients with high levels. These data suggest that PITX2 is strongly associated with the aggressiveness of breast cancer rather than only with response to therapy. Epigenomics believes that the marker constitutes a valuable tool for clinicians and pathologists to further classify breast cancer into more or less aggressive subtypes, and to adapt treatment accordingly. The study forms part of the research program Epigenomics is conducting in a partnership with Roche Diagnostics.
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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