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Leica, Abbott Developing Automated FISH Test for HER2

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Leica Microsystems and Abbott today announced a deal to develop a fully automated fluorescent in situ hybridization solution for HER2 testing.

Under the terms of the deal, Abbott will supply FISH probes targeting the HER2 gene locus, which will be used to develop the automated HER2 FISH test on Leica's BOND automated advanced staining platform.

Terms of the deal were not disclosed.

In a statement, Leica said that Abbott's PathVysion FISH assay is the gold standard ISH test for diagnosing response to Herceptin, a frontline therapy for breast cancer. Leica will develop an automated version of the test on the BOND platform using a standard protocol, and said that automation on its platform "will enable pathology laboratories to run this diagnostic test more efficiently."

Abbott's PathVysion HER-2 DNA Probe Kit is FDA approved and is designed to detect amplification of the HER-2/neu gene via FISH in formalin-fixed, paraffin-embedded human breast cancer tissue specimens.