Application Note

High Quality Tissue Essential in Developing Predictive Biomarker Assays

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Results from any analytical assay are only as reliable as the quality of the analytes that are being evaluated. The tissue sample quality is of the utmost important factor for accurately assessing genes and proteins as closely presented/expressed clinically in the patient’s tumor. Here, breast cancer patient samples sourced from various biobanks were assessed for HER2 (ERBB2) gene amplification and protein overexpression using three different analytical methods. Indivumed Services’s high quality tissues (low ischemic time and high standard tissue processing procedure) showed the highest concordance rate of HER2 status as determined by the new GeneXpert Breast Cancer Biomarker Assay (Xpert BC) and the two-standard method of analyzes immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH).

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  • The accuracy of the established Xpert BC assay assessment by deriving positive and negative measured agreements as well as overall percent agreement when compared to the standard assays (IHC and FISH).

  • Which samples showed the highest concordance rate (100%) in all measured agreement including the OPA for high concordance in comparison to other tissue sources.

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