Abbott Molecular Inc.: PathVysion HER-2 DNA Probe Kit

PathVysion HER-2 DNA Probe Kit

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Laboratory Specifications

	30-161060	20 Assays
	35-161060	50 Assays
	36-161060	100 Assays

Intended Use
The PathVysion HER-2 DNA Probe Kit (PathVysion Kit) is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalinfixed, paraffin-embedded human breast cancer tissue specimens. Results from the PathVysion Kit 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 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 is indicated as an aid in the assessment of patients for whom HERCEPTIN (Trastuzumab) treatment is being considered (see HERCEPTIN package insert).

HER-2/neu, also known as c-erbB2 or HER-2, is a gene that has been shown to play a key role in the regulation of cell growth. The gene codes for a 185 kd transmembrane cell surface receptor that is a member of the tyrosine kinase family.HER-2 has been shown to be amplified in human breast, ovarian, and other cancers.

Warning
The Vysis PathVysion Kit is not intended for use to screen for or diagnose breast cancer. It is intended to be used as an adjunct to other prognostic factors currently used to predict disease-free and overall survival in stage II, node-positive breast cancer patients. In making decisions regarding adjuvant CAF treatment, all other available clinical information should also be taken into consideration, such as tumor size, number of involved lymph nodes, and steroid receptor status.No treatment decision for stage II, node-positive breast cancer patients should be based on HER-2/neu gene amplification status alone.

DNA Probe Description
The PathVysion HER-2 DNA Probe Kit consists of two labeled DNA probes. The LSI^® HER-2 probe that spans the entire HER-2 gene is labeled in SpectrumOrange. The CEP^® 17 probe is labeled in SpectrumGreen^TM and hybridizes to the alpha satellite DNA located at the centromere of chromosome 17 (17p11.1-q11.1). Inclusion of the CEP 17 probe allows for the relative copy number of the HER-2 gene to be determined.

Results of Hybridization
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 ≥ 2.0; normal specimens showed a ratio of less than 2.0. Results at or near the cut-off point (1.8-2.2) should be interpreted with caution.

For In Vitro Diagnostic Use.

Intended Use
The PathVysion HER-2 DNA Probe Kit (PathVysion Kit) is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the PathVysion Kit 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 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 is indicated as an aid in the assessment of patients for whom HERCEPTIN (Trastuzumab) treatment is being considered (see HERCEPTIN package insert).

Warning:
Note: All of the patients in the Herceptin^® clinical trials were selected using an investigational immunohistochemical assay. The PathVysion assay was compared to the CTA on a subset of clinical trial samples and found to provide acceptably concordant results. The actual correlation of the PathVysion assay to Herceptin clinical outcomes in prospective clinical trials has not been established.

The Vysis PathVysion Kit is not intended for use to screen for or diagnose breast cancer. It is intended to be used as an adjunct to other prognostic factors currently used to predict disease-free and overall survival in stage II, node-positive breast cancer patients. In making decisions regarding adjuvant CAF treatment, all other available clinical information should also be taken into consideration, such as tumor size, number of involved lymph nodes, and steroid receptor status. No treatment decision for stage II, node-positive breast cancer patients should be based on HER-2/neu gene amplification status alone. The potential risks associated with misuse of the assay, or misinterpretation of the test results would be to assign patients to receive an adjuvant therapy regimen which is either too low for optimum effectiveness, or higher than necessary, potentially exposing the patient to serious side effects and, in rare cases, death. Selected patients with breast cancers shown to lack amplification of HER-2/neu, may still benefit from CAF adjuvant therapy on the basis of other prognostic factors which predict poor outcome. Conversely, selected patients with breast cancers shown to contain gene amplification may not be candidates for CAF therapy because of pre-existing or intercurrent medical illnesses. The dose and schedule of cyclophosphamide, doxorubicin, and 5-fluorouracil in the CAF regimen have not been standardized. Vysis will provide training in specimen preparation, assay procedure, and interpretation of FISH testing of the Her-2 gene for inexperienced users.