title: Making the Leap from Research Laboratory to Clinic: Challenges and Opportunities for Next-Generation Sequencing in Infectious Disease Diagnostics.
abstract: Next-generation DNA sequencing (NGS) has progressed enormously over the past decade, transforming genomic analysis and opening up many new opportunities for applications in clinical microbiology laboratories. The impact of NGS on microbiology has been revolutionary, with new microbial genomic sequences being generated daily, leading to the development of large databases of genomes and gene sequences. The ability to analyze microbial communities without culturing organisms has created the ever-growing field of metagenomics and microbiome analysis and has generated significant new insights into the relation between host and microbe. The medical literature contains many examples of how this new technology can be used for infectious disease diagnostics and pathogen analysis. The implementation of NGS in medical practice has been a slow process due to various challenges such as clinical trials, lack of applicable regulatory guidelines, and the adaptation of the technology to the clinical environment. In April 2015, the American Academy of Microbiology (AAM) convened a colloquium to begin to define these issues, and in this document, we present some of the concepts that were generated from these discussions.
authors.affiliation: Division of Pediatric Infectious Diseases, Children's National Medical Center, Washington, DC, USA.
authors.forename: Brittany
authors.initials: B
authors.lastname: Goldberg
authors.affiliation: Division of Microbiology Devices, Food and Drug Administration, Office of In Vitro Diagnostics and Radiological Health, Silver Spring, Maryland, USA.
authors.forename: Heike
authors.initials: H
authors.lastname: Sichtig
authors.affiliation: American Society for Microbiology, Washington, DC, USA.
authors.forename: Chelsie
authors.initials: C
authors.lastname: Geyer
authors.affiliation: Department of Pathology, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
authors.forename: Nathan
authors.initials: N
authors.lastname: Ledeboer
authors.affiliation: The Jackson Laboratory for Genomic Medicine, Farmington, Connecticut, USA George.Weinstock@jax.org.
authors.forename: George M
authors.initials: GM
authors.lastname: Weinstock
mesh_terms: D003141:Communicable Diseases / Q000175:diagnosis*; D059014:High-Throughput Nucleotide Sequencing / Q000379:methods* / Q000592:standards / Q000639:trends; D008828:Microbiological Techniques / Q000379:methods* / Q000592:standards / Q000639:trends; D025202:Molecular Diagnostic Techniques / Q000379:methods* / Q000592:standards / Q000639:trends; D012958:Societies, Scientific; D014481:United States