Molecular Diagnostics : Current Research and Applications.

Intro -- Contributors -- Contents -- Current books of interest -- Foreword -- Biographies -- 1: Molecular Diagnostics: An Introduction -- Part I: Molecular Diagnostics in Cancer: Research and Development of Biomarkers -- 2: Transcriptome-based Biomarkers: A Road Map Exemplified for Peripheral Blood-based Biomarker Discovery, Development and Clinical Use -- Introduction -- Defining biomarker classes as a prerequisite for successful biomarker development -- Focus on peripheral blood-based biomarkers as an example -- Blood transcriptomics started in leukaemia research -- Is there a role for blood transcriptomics in other diseases? -- Is there a role of blood transcriptomics for early detection of disease? -- General guidance towards successful biomarker development -- Importance of technical and organizational aspects during biomarker development -- Requirements for bioinformatics analysis during biomarker development -- The next decade of blood transcriptomics -- 3: Development of Methylation Biomarkers for Clinical Applications and Methylation-sensitive High-resolution Melting Technology -- DNA methylation -- Methylation-based in vitro diagnostic tests -- Fields of applications of in vitro diagnostic tests -- Challenges of methylation biomarker development process -- Methylation biomarker development workflow -- PCR amplification and melting analyses in methylation studies -- Development of methylation-sensitive high-resolution melting (MS-HRM) -- Characteristics of the MS-HRM protocol -- Final remarks -- 4: Genetic and Epigenetic Biomarkers of Colorectal Cancer -- Introduction -- Biomarkers -- Biomarker location -- Practical limitations -- Conclusions and outlook -- Part II: Molecular Diagnostics of Infectious Diseases: Past, Present and Future -- 5: Molecular Diagnosis in Medical Microbiology: The Horizon Draws Near -- Introduction.

Enhancing diagnosis -- Molecular typing in control of infection -- Molecular tools in screening/high-throughput analysis -- Considerations in selecting a molecular tool -- Conclusion -- 6: Viral Diagnostics and qPCR-based Methodologies -- Introduction -- PCR-based methods -- Non-PCR-based methods -- Perspectives -- Validation/standardization/harmonization -- Conclusions -- 7: XMRV: A Cautionary Tale -- Introduction -- Discovery of XMRV -- Reports of XMRV in prostate cancer and chronic fatigue syndrome -- Mounting negative evidence ignites XMRV controversy -- Human pathogen or laboratory contaminant? -- The recombinant origin of XMRV -- Dénouement and conclusions -- Note added in proof -- 8: Ancient DNA and the Fingerprints of Disease: Retrieving Human Pathogen Genomic Sequences from Archaeological Remains Using Real-time Quantitative Polymerase Chain Reaction -- Introduction -- aDNA breakdown after deposition -- Why study aDNA and what can it tell us? -- Sampling and measures to avoid cross-contamination -- PCR -- Validation of PCR findings -- Conclusions -- Part III: From Bench to Bedside -- 9: Point-of-care Nucleic Acid Testing: User Requirements, Regulatory Affairs and Quality Assurance -- Nucleic acid testing - key applications -- Testing sites and system requirements - centralized laboratories -- Testing sites and system requirements - POC settings -- Regulatory requirements for IVD manufacturers -- Quality assurance for IVD test execution -- Conclusions -- 10: Point-of-care Nucleic Acid Testing: Clinical Applications and Current Technologies -- Nucleic acid testing - key applications -- NAT process overview -- Case studies -- Systems that integrate amplification and detection -- Conclusions -- 11: From Bench to Bedside: Development of Polymerase Chain Reaction-integrated Systems in the Regulated Markets -- Introduction.

Key-note 1: PCR formulation -- Key-note 2: assay stabilisation -- Key-note 3: the sample extraction reagent interface -- Key-note 4: nucleic acid extraction -- Key-note 5: signalling and automated analysis -- Key-note 6: suppliers and GMP -- Key-note 7: system validation -- Key-note 8: the regulatory process -- Summary -- Part IV: The Future -- 12: Future of Molecular Diagnostics: The Example of Infectious Diseases -- Introduction -- In vitro amplification technologies -- Fully automated and integrated molecular diagnostics systems -- Recent advances and emerging real-time PCR technologies -- Isothermal amplification methods -- Molecular hybridization -- Digital PCR -- Mass spectrometry -- Sequencing -- Concluding remarks -- Index.

The editors of this book have commissioned an excellent series of chapters representing two key molecular diagnostic areas: cancer and infectious diseases. The cancer section deals with the challenges in identifying genetic, epigenetic and transcriptomic biomarkers. The infectious disease section describes the current clinical applications of molecular diagnostics for the detection of viral, bacterial and fungal pathogens as well as an example of the use of molecular diagnostics outside the clinic environment. A cautionary tale describing what can go wrong when molecular methods are applied incorrectly is also provided and makes fascinating reading. A substantial component of the book is dedicated to the process of translating a preclinical test to the bedside and describes the progress in the near patient point-of-care molecular diagnostics market. This is a fundamental consideration for successful translation of diagnostics tests from bench to bedside and is crucial for molecular diagnostics to have an impact on patient care. The final chapter offers a prediction of future trends in the molecular diagnostics of infectious diseases. This volume is essential reading for anyone involved in the development or application of molecular diagnostics and is recommended for all clinical diagnostics laboratories.

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Electronic reproduction. Ann Arbor, Michigan : ProQuest Ebook Central, 2024. Available via World Wide Web. Access may be limited to ProQuest Ebook Central affiliated libraries.