In Situ Hybridization in Clinical Biomarker Development

  • Usha Singh
  • Marisa Dolled-Filhart
  • Dianna Wu
Part of the AAPS Advances in the Pharmaceutical Sciences Series book series (AAPS, volume 21)


Biomarkers are being utilized from early to clinical phases of drug development. Nucleic acid-based biomarkers have proven their significance in predicting disease occurrence, identifying the reason for variable drug responses and helping in personalized targeted therapy. There are various techniques available for analyzing nucleic acid-based biomarkers in body fluids and in tissue homogenates; however, detection of tissue-based biomarkers in the context of tissue/cell morphology is still limited to the use of in situ hybridization (ISH) technology. This book chapter provides an overview of available ISH technologies, efforts made toward the advancement of ISH to increase the sensitivity and specificity of assays and their applications in clinical biomarker.


ISHIn Situ Hybridization Formalin Fixed Paraffin Embed Tissue Micro Array Formalin Fixed Paraffin Embed Tissue Locked Nucleic Acid Probe 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Key terms


Biomarker is an indicator of normal and pathogenic process, progress of disease, or effect of therapeutic interventions and it can be measured in body fluids or tissues

In situ hybridization (ISH)

In situ hybridization (ISH) is a type of hybridization method that uses a labeled complementary DNA or RNA strand to localize a specific DNA or RNA sequence in a section of tissue

Formalin fixed paraffin embedded (FFPE) tissue

It is tissue processing method used in histology labs to preserve and archive clinical specimens

Tissue Micro Array (TMA)

TMA consists of multiple separate tissue cores that are assembled in array fashion to allow multiplex histological analysis


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Copyright information

© American Association of Pharmaceutical Scientists 2016

Authors and Affiliations

  1. 1.Translational MedicineMerck & Co.RahwayUSA

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