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The following complimentary webcasts are scheduled. Please register to participate:

NGS Webinar

Blueprint to Blue Sky: Analysing the Challenges and Solutions for IHC Companion Diagnostics

Date: August-6-2015
Time: 10:00am EDT / 3:00pm BST

The world of biomarker research has changed dramatically over the last 20 years with targeted therapy fundamentally changing drug development practices; there are not only new biomarkers but there are also complex biomarkers such as PD-L1. The situation has moved to a matrix of therapeutics and companion diagnostics, rather than the direct 1:1 relationship of the past.
With all this complexity it is essential to ensure the accuracy of biomarker analysis, however, manual assessments of complex biomarker expressions have been associated with significant inter- and intra-reader variability. There are ways of reducing certain types of errors associated with biomarker assessment and studies have shown that quantitative image analysis may be the solution. Therefore an essential part of blue sky thinking is toward the development of HDx IHC Reference Standards and Quantitative Digital Pathology methods to deliver a strong scoring confidence.

In response to the challenges of comparability of companion diagnostics, a blueprint proposal was discussed at the FDA-AACR-ASCO Public workshop on March 24 2015. This blueprint proposal acts as a PD-L1 comparison study and here a few highlights of the valuable efforts will be discussed.

Key Topics

  • Analysis of the key challenges facing IHC companion diagnostics and solutions such as the ‘Blueprint Proposal’.
  • Blue sky thinking in the development of an IHC reference material including the assessment by Quantitative Digital Pathology.
  • Standardizing IHC staining evaluation using high-quality image analysis systems.