WILEX AG 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.
The serum HER-2/neu test measures the serum HER-2/neu level for the management and monitoring of patients with metastatic breast cancer (MBC). HER-2 (Human Epidermal Growth Factor Receptor 2) is a protein found on some types of cancer cells, especially breast cancer cells. MBC patients who overexpress the HER-2/neu protein tend to have a worse prognosis and a more aggressive disease. The test measures changes in the HER-2 status with increasing serum levels of HER-2/neu being reflective of cancer progression while decreasing serum levels being reflective of therapy response. As the HER-2 tumour status may change between primary and metastatic breast cancer tumours, the serum HER-2/neu ELISA test can help monitor these changes in HER-2/neu levels and aid doctors in managing new treatment options. This test offers laboratories an efficient, reliable and cost-transparent possibility for the measurement of HER-2/neu in serum with no need of further equipment.
Professor Olaf G. Wilhelm, CEO of WILEX Inc. and WILEX AG, comments: “The Chinese market is expected to be one of the fastest growing pharma markets in the world. Therefore, we are pleased to have in GeneDiagnostics a competent partner to pursue an IVD approval for our serum HER-2/neu test as well as to distribute the test in this key market.”
“According to the latest statistics from the Chinese Ministry of Health 126,000 new cases of breast cancer were reported each year. This corresponds to roughly one-tenth of the world’s total and is expected to increase by at least 4% annually. We look forward to introducing this HER-2/neu ELISA test into the Chinese market as we believe that it can help physicians administer targeted treatments to carefully diagnosed patients with metastatic breast cancer”, said Dr Mark Han, President and Chief Scientist of GeneDiagnostics Inc.
Click here for the complete issue.