Antibody Test for Breast Cancer Cleared by FDA

A new monoclonal antibody for HER 2/neu diagnostic testing has been cleared by the U.S. Food and Drug Administration (FDA). The test is indicated as an aid in the assessment of breast cancer patients who could benefit from Herceptin therapy (Genentech, San Francisco, CA, USA).

The antibody, called Pathway (clone CB11), is for laboratory detection of the c-erB-2 antigen in breast cancer. Pathway is a very specific and highly sensitive antibody that outperforms other tests utilizing polyclonal antibodies to detect the overexpression of c-erB-2 antigen, says the developer, Ventana Medical Systems, Inc. (Tucson, AZ, USA).
In a phase II clinical study of Herceptin administered in combination with Taxol, CB11 was shown to be a superior predictor of response to the therapy.

Pathway was FDA-approved for use on Ventana's automated immunohistochemistry (IHC) slide-staining systems, including ES, NexES, and the new BenchMark. Ventana develops and markets instrument and reagent systems that automate tissue preparation and slide staining in clinical and drug discovery laboratories.

"With time to treatment being a critical factor in the fight against breast cancer, laboratories will be able to deliver consistent and reliable results within four hours of receiving the tissue biopsy,” said Christopher Gleeson, president and CEO of Ventana.



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