TEST:

SPOT-LIGHT HER2 CISH Kit

The SPOT-Light® HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin- fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections using chromogenic in situ hybridization (CISH) and hrightfield microscopy. This test should be performed in a histopathology laboratory. The SPOT-Light® HER2 CISH Kit is indicated as an aid in the assessment of patients for whom Hercepting (trastuzumnab) treatment is being considered. The assay results are intended for use as an adjunct to the clinicopathological information currently being used as part of the management of breast cancer patients. Interpretation of test results must be made within the context of the patient's clinical history by a qualified pathologist.