Leica receives FDA Pre-Market Approval for new HER2 IHC test

Leica Biosystems, a division of Leica Microsystems, announced that it has received Pre-Market Approval from the U.S. Food and Drug Administration for the Leica Bond Oracle HER2 IHC System (Product Code TA9147) with the Leica BOND-MAX, establishing their commitment to developing quality companion diagnostic products. The Leica Bond Oracle HER2 IHC System is a complete solution of ready-to-use reagents, HER2 control slides and Leica BOND-MAX instrumentation, designed to deliver increased diagnostic confidence and drive laboratory efficiency in HER2 IHC testing.

"The Leica Bond Oracle HER2 IHC System demonstrates high concordance to HER2 FISH," comments Arnd Kaldowski, President of Leica Biosystems. "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. With the Oracle system, laboratories also obtain the speed and efficiencies of Leica BOND-MAX instrumentation, delivering more effective workflow management."

The Leica Bond Oracle HER2 IHC System is intended for use on formalin-fixed, paraffin-embedded tissue, and can be used simultaneously with all other BOND protocols allowing unparalleled flexibility and workflow efficiency.

In clinical trials the Leica Bond Oracle HER2 IHC System achieved 2x2 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 decreased process variation, increased protocol standardization and the delivery of consistent results. Confidence is further enhanced by the use of HER2 Control Slides demonstrating 0, 1+, 2+ and 3+ staining. "Use of the 2+ (equivocal) cell line, has the potential to improve assay performance, as this is a sensitive indicator of problems associated with antigen retrieval, primary antibody, or detection system," says Dr. Anthony O'Grady, Beaumont Hospital, Ireland.

Leica Bond Oracle HER2 IHC System is a semi-quantitative immunohistochemical (IHC) assay to determine HER2 (Human Epidermal Growth Factor Receptor 2) oncoprotein status in breast cancer tissue processed for histological evaluation. The Leica Bond Oracle HER2 IHC System is indicated as an aid in the assessment of patients for whom Herceptin® (trastuzumab) treatment is being considered.

SOURCE Leica Microsystems