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FDA Approves BioGenex InSite™ HER-2/neu (CB11) Monoclonal Antibody

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BioGenex Laboratories Inc. has announced that it has received Pre-Market Approval from the FDA for its InSite™ HER-2/neu (CB11) Monoclonal Antibody.

This antibody is used in tests to identify breast cancer patients eligible for treatment with the cancer drug Herceptin® (Trastuzumab).

InSite™ HER- 2/neu (CB11) is available as a ready-to-use reagent, in manual and automated formats, and is allowed for use with BioGenex Super Sensitive™ Detection Systems.

The automated format is approved for use on the BioGenex i6000™ Automated Staining System and the Optimax® Plus Consolidated Staining System.

Both manual and automated versions of InSite™ HER-2/neu (CB11) Monoclonal Antibody will be marketed worldwide.

With this approval, BioGenex's customers will have the option of purchasing a HER-2/neu test and materials a la carte or a complete kit, i.e. the previously approved InSite™ HER-2/neu kit.

BioGenex offers over 250 IHC tests for cancer diagnosis, including a complete panel for breast cancer, with additional FDA cleared tests.

“The FDA approval of our InSite™ HER-2/neu antibody is not only beneficial to our customers, it also affirms our promise to accelerate the pace of predictive medicine for improved patient care, longer survival and enhanced quality of life,” said Krishan L. Kalra, Ph.D., Chairman and CEO of BioGenex.

“We now have a complete offering for HER-2/neu testing - our complete kit and our standalone antibody. By offering both options, we are providing flexibility to our customers.”

In immunohistochemical tests, InSite™ HER-2/neu (CB11) detects a protein (HER-2/neu tyrosine kinase) in the body that stimulates cancerous cell growth.

Overexpression of the HER-2/neu protein is seen in 25-30% of breast cancer patients.

The detection of this protein indicates eligibility for breast cancer treatment with the drug Herceptin® (Trastuzumab).