Warnings and Precautions

Warning
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 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 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 pre-existing or intercurrent medical illnesses.

Required Training
Vysis will provide training 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.

Warnings and Precautions
The PathVysion Kit is intended for use only on formalin-fixed, paraffin-embedded breast cancer tissue; it is not intended for use on fresh or non-breast cancer tissue.

All biological specimens should be treated as if capable of transmitting infectious agents.  The ProbeChek control slides are manufactured from human cell lines that have been fixed in 10% formalin. Because it is often impossible to know which might be infectious, all human specimens and control slides should be treated with universal precautions. Guidelines for specimen handling are available from the U.S. Centers for Disease Control and Prevention¹.

For a complete package insert for the PathVysion HER-2 DNA Probe kit, contact Abbott Molecular Technical Services.

¹U.S. Centers for Disease Control.  Morbidity and Mortality Weekly Review.  1987;36(suppl. 2S):2S- 18S.