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2020 Sept 10 - Clinical Assay Development using ACD’s in situ Hybridization Assay Services
Shauna Levinson
Senior Research Associate, PAS, Advanced Cell Diagnostics
Watch Video:
Alpana Kumari, Ph.D., PMP.
Scientific Consultant, PAS, Advanced Cell Diagnostics
Outline:

Advanced Cell Diagnostics’ RNAscopeTM in situ hybridization (ISH) platforms are widely utilized for high resolution tissue-based and cell-specific analysis of targets and biomarkers. The RNAscope ISH platform is clinically validated and enables quantitative expression analysis that has repeatedly been proven to better stratify treatment-responsive and non-responsive patients in therapeutic clinical trials compared to traditional methods such as IHC and qPCR. RNAscope is often more sensitive than IHC and provides cell-specific biomarker data in complex tissue microenvironments that qPCR cannot. A further advantage is speed: RNAscope biomarker assays can be verified and ready for use on clinical biopsies in a matter of weeks.

Learning Objectives:
  • Biomarker validation to accelerate translation of assays into clinical development in a GCLP setting
  • Assay feasibility and development - sensitivity, specificity, and precision testing (repeatability & reproducibility)
  • Development of pathologist scoring and HALOTM image analysis algorithms for biomarker assessment
  • Established protocols for clinical assay transfer to CLIA-certified labs for prospective use
  • RNAscope multiplexing and validated protocols for co-detection of biomarkers and immune cell markers
  • Quantifiable, cell-specific, single-molecule detection of RNA biomarkers in tumor biopsies
  • Superior performance against traditional methods, e.g., IHC, qPCR
  • Application in small molecule, biologic and cell therapy biomarkers

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