Anti-Her2 RabMAb Receives FDA Approval for Breast Cancer Diagnostic
Burlingame, CA - January 18, 2007
Ventana Medical Systems, Inc. today announced it has received approval from the US Food and Drug Administration (FDA) for the use of its PATHWAY® HER-2/neu (4B5) Rabbit Monoclonal Antibody as an aid in the assessment of breast cancer patients for whom Herceptin® treatment is considered. This antibody has also been approved for use on the Ventana Image Analysis System (VIAS(TM)).
The over-expression of HER2 causes breast cancer cells to grow more rapidly and renders customary chemotherapy less effective. Herceptin is a targeted therapy against the HER2 protein on breast cancer cells. PATHWAY® HER-2/neu (4B5) is intended for laboratory use for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue on a Ventana automated immunohistochemistry slide staining device.
"We are pleased with the FDA's decision to approve the RabMAb against HER-2/neu (4B5)," said Dr. Guo-Liang Yu , President and Chief Executive Officer. "This new test provides pathologists and oncologists with an outstanding diagnostic tool and is the result of our RabMAb technology. Our partnership with Ventana has resulted the second FDA approved companion diagnostic product that assist physicians in the selection of personalized therapies which improve healthcare."
Herceptin® (trastuzumab) is manufactured by Genentech, Inc., San Francisco, CA.
Epitomics, Inc., an emerging biotechnology company, is dedicated to developing breakthrough monoclonal antibody technology for research, diagnostic and therapeutic applications. The Company utilizes a unique and proprietary RabMAb® (Rabbit Monoclonal Antibody) technology which produces antibodies with superior binding affinity and bioactivity in a wide variety of biological assays. Epitomics, Inc. (www.epitomics.com) is headquartered in Burlingame, California, and operates a wholly owned subsidiary in Hangzhou, the People's Republic of China.
RabMab technology is used for the discovery and development of monoclonal antibodies to treat cancer and other diseases. Compared to currently available MAb technology on the market, such as mouse hybridomas, Epitomics' technology can generate RabMAbs more efficiently and can offer RabMAbs with superior binding affinity and bioactivity in a wide variety of biological assays. The high throughput and robust nature of the technology allows for the simultaneous discovery of disease targets and potential therapeutic antibodies in the same experiments, significantly shortening the drug discovery and development cycle.