Acquired genetic alteration IVDs

Intended purpose

The VENTANA anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody (VENTANA HER2 (4B5)) is intended for the semi-quantitative detection of HER2 antigen in sections of formalin-fixed, paraffin-embedded normal and neoplastic breast and gastric tissue on a Ventana automated slide staining device. It is indicated as an aid in the assessment of breast and gastric cancer patients for whom Herceptin treatment is considered. The results of this test should be evaluated within the context of the patient’s clinical history and other diagnostic tests evaluated by a qualified pathologist. Any staining performed in the end user’s lab should be interpreted within the context of the controls run with the clinical cases at the time of evaluation.