Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN News Highlights

More »
Apr 25, 2012

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

  • 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.” 



Related content

Be sure to take the GEN Poll

Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

More »