BioGenex Laboratories Inc has announced the FDA approval of its InSite Her-2/neu Kit.

This in vitro diagnostic kit is used to identify breast cancer patients eligible for treatment with the cancer drug Herceptin (Trastuzumab). InSite Her-2/neu is a complete kit, containing all components required for the performance of IHC staining of breast cancer tissue.

Krishan Kalra, chairman and CEO, BioGenex said, "Our goal in 2005 is to accelerate the Pace of Predictive Medicine by providing products that will revolutionize the IHC marketplace and help in the fight against cancer. InSite Her-2/neu Kit is the only complete monoclonal antibody and detection kit of its kind in the market, and we're proud to have it as part of our product portfolio."

This test is used by pathologists to analyze breast cancer tissue sections. The test detects a protein (Her-2/neu tyrosine kinase) in the body that stimulates cancerous tissue cell growth. Overexpression of the Her-2/meu protein is seen in 25-30 per cent of breast cancer patients. The presence of this protein indicates eligibility for breast cancer treatment with the FDA approved drug Herceptin.

InSite Her-2/neu is a new product and is the only kit of its kind in the market to contain the monoclonal antibody against Her-2/neu (Clone CB11). This monoclonal antibody has higher consistency and specificity as compared to its polyclonal antibody counterpart.

The FDA has approved two formats of the InSite Her-2/neu Kit - manual and automated. The latter is approved for use on the BioGenex i6000 Automated Staining System and the OptiMax Plus Consolidated Staining System. BioGenex also has two additional FDA cleared tests for breast cancer, targeting the markers for Estrogen and Progesterone Receptors. These antibodies are proprietary to BioGenex and were previously cleared by the FDA.