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GEN News Highlights : Apr 25, 2012

FDA Clears Leica’s Her2 Immunohistochemical Assay on Bond-Max Instrument

Fully automated assay determines Her2 status in FFPE tissue.

Leica Microsystems received FDA approval for its fully automated Leica Bond Oracle Her2 IHC assay used with the Leica Bond-Max™ instrumentation. The semiquantiative immunohistochemical test is designed to determine Her2 status in breast cancer on formalin-fixed, paraffin-embedded tissue samples.

In trials the Leica Bond Oracle Her2 IHC test achieved 2x2 concordance of 87.6% and a positive agreement of 93.8% with the Abbott Molecular PathVysion Her2 DNA Probe kit, which is the current gold-standard for assessing Her2 status, Leica says. “The Leica Bond Oracle Her2 HIC system is validated as a fully automated Her2 IHC test, and delivers the diagnostic confidence that comes with proven Her2 FISH concordance,” states Arnd Kaldowski, Leica's president. “With the Oracle system, laboratories also obtain the speed and efficiencies of the Leica Bond-Max instrumentation, delivering more effective workflow management.”