Polymerase chain reaction

Karen Yu, Sylwia Karwowska, Abha Sharma, Oliver Liesenfeld, Sidney A. Scudder

Research output: Chapter in Book/Report/Conference proceedingChapter


Polymerase chain reaction (PCR) has revolutionized laboratory diagnostics over the last two decades. The introduction of precision medicine to therapeutic fields, such as oncology, resulted in the need for precise diagnostic tests to qualify or disqualify patients from certain therapeutic regimens. In addition to immunohistochemistry, PCR has demonstrated great value as a companion diagnostic technique. There are multiple PCR-based tests approved by regulatory agencies. The present chapter focuses on the history of PCR and the role of PCR as a companion diagnostic test. We provide detailed guidance on requirements for the development of PCR tests as companion diagnostics including the analytical verification and validation studies required, clinical studies to be performed and the collaboration between the pharma and diagnostic partner overall.

Original languageEnglish (US)
Title of host publicationCompanion and Complementary Diagnostics
Subtitle of host publicationFrom Biomarker Discovery to Clinical Implementation
Number of pages23
ISBN (Electronic)9780128135396
ISBN (Print)9780128135402
StatePublished - Jan 1 2019
Externally publishedYes


  • Clinical trials
  • Companion diagnostics
  • Oncology
  • Pcr
  • Validation
  • Verification

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)


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