Polymerase chain reaction

Abstract 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.