Wilex AG and GeneDiagnostics Inc. Enter Into Partnership for the IVD Approval and Distribution of the Serum HER-2/neu Test in China
Published: Jan 23, 2013
MUNICH & HANGZHOU, China--(BUSINESS WIRE)--WILEX AG (ISIN DE0006614720 / WL6 / Frankfurt Stock Exchange) today announced that its US subsidiary WILEX Inc., Cambridge, MA, has entered into an exclusive distribution agreement with GeneDiagnostics Inc. for the commercialization of the serum HER-2/neu ELISA test in China. This biomarker test is FDA cleared in the USA, carries the CE mark for the European market, and is currently for Research Use Only in the Chinese market. GeneDiagnostics plans to conduct clinical studies in leading hospitals in China for the IVD clearance through the State Food and Drug Administration in China (SFDA) as part of the terms. GeneDiagnostics is a clinical research and service provider based in Hangzhou, China, and has well-established business relationships with major hospitals. Financial terms of the agreement were not disclosed.