Sividon Diagnostics GmbH
Precision Diagnostics ‘Made in Germany’ Now Available In China – EndoPredict(R) Spares Breast Cancer Patients Unnecessary Chemotherapy
The EndoPredict gene expression test developed and manufactured in Cologne now becomes available to breast cancer patients in the world’s most populous country: in China. This is made possible by a collaboration between the manufacturer, Sividon Diagnostics, and the Shanghai-based company Virchow Laboratories with its sales partner Ready Ruixin. EndoPredict is recommended by international guidelines for determination of the relapse risk of breast cancer patients. It is often the crucial criterion in deciding for or against chemotherapy.
Gene expression tests are based on analysis of biochemical messengers in the tumour. These tests are among the most complex procedures carried out in molecular pathology. Accordingly, with earlier tests of this kind the analysis could be performed only in the manufacturers’ specialised laboratories. EndoPredict has made it possible for the first time to carry out these important diagnostic tests close to the patient, in the local pathology department. “Using EndoPredict, treatment of cancer patients can now be improved in China as well”, said Wang Jian, CEO of Virchow Laboratories in Shanghai. “Shipment of tumour tissue for analysis abroad is not easy under Chinese law. Our cooperation enables Chinese patients to finally also get access to this cutting-edge diagnostics. It will allow more specific treatment for many women, and in many cases avoid extremely stressful but unnecessary chemotherapy.” Sividon Diagnostics, several German university institutes as well as the Austrian ABCSG Study Group were involved in the development and validation of EndoPredict. “In particular, the impressive results of a collaborative study demonstrating the accuracy and reliability of the EndoPredict test in the decentralized setting have convinced us to bring the test to China”, said Wang Jian. “The validation studies lead us to expect that we will be able to safely avoid chemotherapy in about 60% of the breast cancer patients tested.” After the market launch in 2011, EndoPredict was first used in the German-speaking countries. “By now, the EndoPredict test is performed in numerous pathology departments throughout Europe”, said Sividon’s CEO, Dr. Christoph Petry. “Outside Europe, too, the test is gaining ever more popularity. It is being used, among others, in Latin America, in Australia and in a growing number of Asian countries. This encourages us to develop even further diagnostic tests, which will facilitate tailor-made therapies for cancer patients worldwide.” EndoPredict is performed in those patients in whom the standard diagnostic procedures do not allow for an unambiguous decision for or against chemotherapy. The test is based on combining the measured activity of specific tumour genes with the classical prognostic factors nodal status and tumour size. Patients with low score can be optimally treated with hormonal therapy alone; high risk patients are likely to derive additional benefit from chemotherapy. 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. Further information is available at www.sividon.com or www.endopredict.com.
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