Leica Microsystems to Develop an Automated HER2 FISH Test with the Leica BOND Staining Platform

Leica Microsystems GmbH and Abbott have reached an agreement for Abbott to supply fluorescence in situ hybridization (FISH) probes that target the HER2 gene locus. The probes will be used to develop a fully automated FISH solution for HER2 testing on the Leica Microsystems’ BOND™ an automated advanced staining platform.

Abbott PathVysion FISH assay is the gold standard ISH (in situ hybridization) test for diagnosing the response of patients to Herceptin. An automated version of this test to be performed on the Leica BOND™system staining platform using a standard protocol. Automation of the HER2 test on the Leica BOND™ system will enable Pathology laboratories to run this diagnostic test more efficiently. “With this new automated test we aim to provide a fast diagnostic result while maintaining the high standard associated with HER2 FISH testing, helping customers to provide time effective, individualized cancer therapy. We are pleased to be working together to advance patient cancer treatment,” stated Arnd Kaldowski, President of Leica Biosystems.

The HER2 FISH test is designed to identify patients that are likely to respond to Herceptin, a drug which is used as a frontline therapy for treatment of breast cancer. Tumors, which over express HER2, are most suitable for treatment with Herceptin. HER2 over expression can be detected at the protein level using IHC (immunohistochemistry) or at the DNA level using ISH.

The Abbott PathVysion® HER-2 DNA Probe Kit (PathVysion Kit), which is FDA approved, 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.