Leica Biosystems, a division of Leica Microsystems, announced that it has received premarket approval from the FDA for its Bond Oracle HER2 IHC System, a semi-quantitative immunohistochemical assay to determine human epidermal growth factor receptor 2 oncoprotein status in formalin-fixed, paraffin-embedded breast cancer tissue processed for histologic evaluation following automated staining on the BOND-MAX slide-staining instrument. The system is indicated as an aid in the assessment of patients for whom trastuzumab (Herceptin) treatment is being considered.
In clinical trials, the Leica Bond Oracle HER2 IHC System achieved 2×2 concordance of 87.6% and a positive agreement of 93.8% with the Abbott Molecular PathVysion HER2 DNA Probe kit, considered the gold standard for assessment of HER2 status. Full automation of HER2 IHC testing facilitates the delivery of consistent results. ■