Essential Steps for Establishing a Molecular Pathology Lab: A Narrative Review

Molecular pathology has emerged at the forefront in the era of personalised and targeted therapy. Molecular testing is essential to identify actionable therapeutic targets, especially in oncology. There is an increasing need to integrate routine histopathology and hematology laboratories with molecular techniques. A slow but definite shift is occurring toward incorporating molecular diagnostics into routine traditional pathology services. However, there remains a significant gap in knowledge and technical knowhow regarding the integration of molecular diagnostic practices within routine histopathology services. With very few regulatory bodies and limited guidelines for day-to-day practice, there is considerable confusion about establishing and operating molecular laboratories. Molecular pathology also includes several subdivisions, such as cytogenetics {Fluorescence In Situ Hybridisation (FISH) and karyotyping}, molecular diagnostics {Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and Next Generation Sequencing (NGS)}, and protein studies (mass spectrometry). The latter is primarily research-based and lies outside the purview of this review article. Immunohistochemistry (IHC) is also considered an integral part of molecular work-up. Each of these individual subdivisions has its own technical, infrastructural, and personnel requirements. NGS, in particular, requires bioinformatics support and stringent quality control measures. In this review article, the necessary infrastructure, instruments, laboratory personnel, and support staff required for establishing and running a molecular laboratory are discussed. Currently, there are very few guidelines and review papers available for setting up molecular pathology laboratories. Through the present review, the authors aim to outline the essential steps involved in establishing and operating a molecular laboratory