Clinical research and service provider GeneDiagnostics has entered into an agreement to distribute WILEX's serum HER-2/neu ELISA test in China.
The FDA-approved and CE-marked biomarker test measures serum HER-2/neu protein levels and monitors changes between primary and metastatic breast cancer tumours.
The measured protein levels facilitate doctors in managing new treatment options for patients with metastatic breast cancer, claims WILEX, a US subsidiary of WILEX AG.
Under the terms of the agreement, GeneDiagnostics plans to conduct clinical trials in leading hospitals in China for the IVD clearance through the State Food and Drug Administration (SFDA).
WILEX CEO professor Olaf Wilhelm said, "The Chinese market is expected to be one of the fastest growing pharma markets in the world."
GeneDiagnostics president and chief scientist Dr Mark Han said, "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."
The financial details of the agreement have not been disclosed.