Leica Microsystems unit Leica Biosystems has received an approval from the US Food and Drug Administration (FDA) for its Bond Oracle HER2 IHC System, which is intended for use on formalin-fixed, paraffin-embedded tissue.
The semi-quantitative immunohistochemical (IHC) assay is used to determine HER2 (Human Epidermal Growth Factor Receptor 2) oncoprotein status in breast cancer tissue processed for histological evaluation.
It is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered.
With a complete solution of ready-to-use reagents, HER2 control slides and Leica BOND-MAX instrumentation, the Leica system is designed to deliver increased diagnostic confidence and drive laboratory efficiency in HER2 IHC testing, said the company.
Leica Biosystems president Arnd Kaldowski was quoted by news-medical.net as saying that the Leica Bond Oracle HER2 IHC System demonstrates high concordance to HER2 FISH.
"The Leica Bond Oracle HER2 IHC System is validated as a fully-automated HER2 IHC test, and delivers the diagnostic confidence that comes with proven HER2 FISH concordance," Kaldowski said.
"With the Oracle system, laboratories also obtain the speed and efficiencies of Leica BOND-MAX instrumentation, delivering more effective workflow management."
The Leica system can be used simultaneously with all other BOND protocols allowing flexibility and workflow efficiency, said the company.
The new achieved 2×2 concordance of 87.6% and a positive agreement of 93.8% with the Abbott Molecular PathVysion HER2 DNA Probe kit in clinical trials.