Translating Molecular Biomarkers into Clinical Assays

Volume 21 of the series AAPS Advances in the Pharmaceutical Sciences Series pp 201-210


In Situ Hybridization in Clinical Biomarker Development

  • Usha SinghAffiliated withTranslational Medicine, Merck & Co. Email author 
  • , Marisa Dolled-FilhartAffiliated withTranslational Medicine, Merck & Co.
  • , Dianna WuAffiliated withTranslational Medicine, Merck & Co.

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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.