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).
HERCEPTIN therapy selection
NOTE: All of the patients in the HERCEPTIN clinical trials were selected using an investigational immunohistochemical assay (CTA). None of the patients in those trials were selected using the PathVysion 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 outcome in prospective clinical trials has not been established.
Adjuvant therapy selection
The 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 and no treatment decision for stage II, node-positive breast cancer patients should be based on HER-2/neu gene amplification status alone. Selected patients with breast cancers shown to lack amplification of HER-2/neu may still benefit from CAF (cyclophosphamide, doxorubicin, 5-fluorouracil) adjuvant therapy on the basis of other prognostic factors that predict poor outcome (e.g. tumor size, number of involved lymph nodes, and hormone receptor status). Conversely, selected patients with breast cancers shown to contain gene amplification may not be candidates for CAF therapy due to preexisting or intercurrent medical illnesses. Required Training
Training will be provided in specimen preparation, assay procedure, and interpretation of FISH testing of the Her-2 gene for inexperienced users. It is also recommended that a laboratory that has previously received training but now has new personnel performing the assay request training for the new users.
1.The PathVysion Kit has been optimized only for identifying and quantifying chromosome 17 and the HER-2/neu gene in interphase nuclei from formalin-fixed, paraffin-embedded human breast tissue specimens. Other types of specimens or fixatives should not be used.
2. The performance of the PathVysion Kit was validated using the procedures provided in the package insert only. Modifications to these procedures may alter the performance of the assay.
3. Performance characteristics of the PathVysion Kit have been established only for node positive patients receiving the designated regimens of CAF and for metastatic breast cancer patients being considered for HERCEPTIN therapy. Performance with other treatment regimens has not been established.
4. The clinical interpretation of any test results should be evaluated within the context of the patient's medical history and other diagnostic laboratory test results.
5. FISH assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate. Technologists performing the FISH signal enumeration must be capable of visually distinguishing between the orange and green signals.
CAUTION: United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; use is restricted to, by, or on the order of a physician.
FOR IN VITRO DIAGNOSTIC USE