Sividon Diagnostics GmbH
ASCO Recommends EndoPredict for Breast Cancer Diagnostics – Update of the Therapy Guideline for Biomarkers

In its updated treatment guidelines, the American Society of Clinical Oncology (ASCO) recommends EndoPredict to determine which patients with primary breast cancer can be treated safely and effectively without chemotherapy.

Since the European Society for Medical Oncology (ESMO) has included EndoPredict as a second-generation gene expression test in its guideline in September 2015, ASCO is now the first professional medical association in the United States to include EndoPredict into its ‘Care and Treatment Recommendations for Patients’. The German AGO guideline has already been recommending the test developed by the German company Sividon Diagnostics for several years.

The prerequisite for the testing is that the tumour cells carry hormone receptors and do not overexpress the growth factor receptor HER2. Approximately 60 % of the patients tested can be spared the stressful chemotherapy thanks to EndoPredict.

“At the San Antonio Breast Cancer Conference last December convincing data were presented showing that EndoPredict is superior over an older test still widely used, particularly in the US. We are extremely pleased that EndoPredict is now recommend by a major professional guideline in the US even before EndoPredict’s market launch in this country”, says Christoph Petry, Ph.D., CEO of Sividon Diagnostics.

“Regulatory approval for the US market is planned to be obtained by the end of this year.”

EndoPredict is the first test of its kind to be carried out by the pathologists on site, thus enabling rapid treatment planning. The test was developed in Germany and has been CE-marked since 2012. Since then, an ever increasing number of pathology labs in Europe and Latin America, in Africa and Asia have been using the EndoPredict.

Sources:

http://jco.ascopubs.org/content/early/2016/02/05/JCO.2015.65.2289.long

http://www.instituteforquality.org/use-biomarkers-guide-decisions-adjuvant-systemic-therapy-women-early-stage-invasive-breast-cancer

http://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/biomarkers-guide-treatment-early-stage-breast-cancer

EndoPredict is a gene expression test to determine the prognosis of patients with breast cancer. Patients with very good prognosis may generally do without stressful chemotherapy. The EndoPredict is particularly expedient for those women whose tumour belongs to the intermediate-risk group according to classical criteria.

Sividon Diagnostics GmbH was founded in July 2010 as a management buyout of Siemens Healthcare Diagnostics Products at the Cologne location. The company’s mission is to sustainably increase the quality of therapy-accompanying diagnostics in oncology. Since 2011, with the EndoPredict(R) the first diagnostic test by Sividon has been available.

For further information, please see www.sividon.com or www.endopredict.com