Sividon Diagnostics GmbH
San Antonio Breast Cancer Conference 2013 – Second-Generation Gene Expression Tests Compared: Most prognostic information provided by EPclin
San Antonio (USA) – Which gene expression test for breast cancer patients adds the most additional prognostic information to common clinical parameters? The Spanish Breast Cancer Research Group (GEICAM) has compared the standardized test for pathology laboratories EndoPredict (EP) and research-based versions of the PAM50 assay. The result: EPclin adds prognostic information beyond the research-based versions of the PAM50 test, likely because EPclin includes information about patient node status. The results were now presented at the San Antonio Breast Cancer Conference. Various gene expression analysis kits are now available to provide reliable prognostic guidance in breast cancer. EndoPredict and PAM50 (Prosigna) are second-generation multigene tests. These test kits are used to determine an individual patient’s prognosis and thereby decide whether breast cancer patients require chemotherapy or not. In contrast to older forerunners, this current test generation also detects the likelihood of late metastases, i.e. metastasis formation after more than five years, and can thus also be used to address the question of the usefulness of extended anti-hormone therapy. As part of the GEICAM/9906 sub-study, the molecular scores were measured and combined with the respective clinical data (for PAM50, with tumour size; for EP, with tumour size and nodal status) to determine the hybrid scores according to the test design. All results were found to be significantly prognostic; both tests allowed identification of a low-risk group with very few relapses within the ten years post diagnosis. ‘The low-risk group was determined with the EPclin and ROR-PT hybrid scores. Of the patients with a low risk according to ROR-PT, 8% developed metastases within ten years, while in the low-risk group according to EPclin there were no relapses at all’, explained Prof. Dr. Miguel Martin, chairman of the GEICAM Research Group. A direct comparison showed that all signatures added prognostic information to common clinical parameters, but only EPclin, compared to the other scores, provides additional information for predicting the likelihood of metastasis. ‘The superior performance of EPclin compared to the research-based PAM50 could be due to the inclusion of the patient’s nodal status. Thus, the prognostic value of genetic signatures can be further improved by integration of clinical risk factors,’ said Prof. Martin. The two methods were compared on the basis of 536 tumour samples (all ER+ / HER2-, node-positive). All the patients were treated with chemotherapy followed by anti-hormonal therapy. Specifically, the EndoPredict (EP) score and two versions of the PAM50 score (the subtype-based ROR-S score and the additionally proliferation-based ROR-P) were measured. In addition, the necessary clinical information was supplemented to obtain the: a) ROR-T score (ROR-S and tumour size), b) ROR-PT score (ROR-P and tumour size) and c) EPclin score (EP score, tumour size and nodal status). Company portrait Sividon Diagnostics GmbH was founded in July 2010 as a management buyout from Siemens Healthcare Diagnostics Products in Cologne, Germany. The company aims to sustainably increase the quality of therapy-accompanying diagnostics in oncology. EndoPredict(R), the first diagnostic test from Sividon, has been available since 2011. The breast cancer prognostic test helps in deciding for which patient a chemotherapy is indicated. For further information, visit www.sividon.com.
End of Media Release Issuer: Sividon Diagnostics GmbH Key word(s): Health 13.12.2013 Dissemination of a Press Release, transmitted by DGAP – a company of EQS Group AG. The issuer is solely responsible for the content of this announcement. DGAP’s Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de |
244725 13.12.2013 |