PathVysion HER-2 DNA Probe Kit II

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The PathVysion HER-2 DNA Probe Kit II (PathVysion Kit II) is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast and gastric cancer tissue specimens.

For breast cancer indication, results from the PathVysion Kit II are intended for use as an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage II, node-positive breast cancer patients. The PathVysion Kit II is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node-positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin and 5-fluorouracil (CAF) chemotherapy. The PathVysion Kit II is indicated as an aid in the assessment of breast cancer patients for whom HERCEPTIN (trastuzumab) treatment is being considered (see HERCEPTIN package insert). PathVysion 02J01 is available in some countries and does not contain the gastric indication.

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Results on enumeration of 20 interphase nuclei from tumor cells per target are reported as the ratio of average HER-2/neu copy number to that of CEP 17. Our clinical study found that specimens with amplification showed a LSI HER-2/neu and CEP 17 signal ratio of greater than or equal to 2.0.

Normal Hybridization: Normal specimens show a ratio of less than 2.0. Results at or near the cut-off point (1.8-2.2) should be interpreted with caution.

Abnormal Hybridization: PathVysion HER-2 DNA Probe Kit hybridized to breast tissue showing multiple copies of the HER-2 gene as represented by multiple orange signals. The ratio of orange to green probe signals is greater than 2.0 indicating HER-2 amplification.