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Related Concept Videos

Next-generation Sequencing03:00

Next-generation Sequencing

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The first human genome sequencing project cost $2.7 billion and was declared complete in 2003, after 15 years of international cooperation and collaboration between several research teams and funding agencies. Today, with the advent of next-generation sequencing technologies, the cost and time of sequencing a human genome have dropped over 100 fold.
Next-Generation Sequencing Methods
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RNA-seq03:21

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RNA sequencing, or RNA-Seq, is a high-throughput sequencing technology used to study the transcriptome of a cell. Transcriptomics helps to interpret the functional elements of a genome and identify the molecular constituents of an organism. Additionally, it also helps in understanding the development of an organism and the occurrence of diseases. 
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Related Experiment Video

Updated: Mar 14, 2026

Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies
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Standardization and quality management in next-generation sequencing.

Christoph Endrullat1, Jörn Glökler1, Philipp Franke1

  • 1Molecular Biotechnology and Functional Genomics, Institute of Applied Biosciences, Technical University of Applied Sciences Wildau, Hochschulring 1, 15745 Wildau, Germany.

Applied & Translational Genomics
|September 27, 2016
PubMed
Summary

Standardization efforts are emerging for DNA sequencing technologies to ensure reliable results. These initiatives address quality management and data handling for next-generation sequencing, crucial for clinical diagnostics.

Keywords:
ABRF, Association of Biomolecular Resource FacilitiesBAM, binary alignment/mapCAP, College of American Pathologist'sCEN, European Committee for StandardizationCLIA, Clinical Laboratory Improvement AmendmentsData qualityERCC, External RNA Controls ConsortiumFDA, Food and Drug AdministrationFFPE, formalin-fixed, paraffin-embeddedFMEA, failure mode and effects analysisGATK, genome analysis toolkitGSC, Genomic Standards ConsortiumGuidelineHGP, Human Genome ProjectIndel, insertion or deletionMAQC, MicroArray Quality Control ProjectMIGS, minimum information about a genome sequenceMOL, molecular pathology checklistNGS, next-generation sequencingNIST, National Institute of Standards and TechnologyNTC, no-template controlNex-StoCT, next generation sequencing — standardization of clinical testingNext-generation sequencingPT, proficiency testingQA, quality assuranceQC, quality controlQM, quality managementQMS, quality management systemQuality managementRIN, RNA integrity numberSAM, sequence alignment/mapSEQC, sequencing quality controlSNP, single nucleotide polymorphismSOP, standard operating procedureStandardizationTN, technical noteVCF, variant call formatValidationddPCR, digital droplet PCRmtDNA, mitochondrial DNAqPCR, quantitative PCR

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Area of Science:

  • Genomics
  • Molecular Biology
  • Bioinformatics

Background:

  • DNA sequencing technology has rapidly advanced over 30 years, with new platforms emerging and old ones disappearing.
  • The advent of next-generation sequencing (NGS) has accelerated progress, driven by demands for higher throughput, lower costs, and improved data quality.
  • Despite rapid development, standardized procedures, data formats, and comprehensive quality management for DNA sequencing remain scarce.

Purpose of the Study:

  • To list and summarize current standardization efforts and quality management initiatives in DNA sequencing.
  • To provide an overview of published studies and ongoing projects from companies, organizations, and societies.
  • To highlight the importance of standardization for the reliable implementation of NGS in clinical diagnostics.

Main Methods:

  • Literature review and project summarization.
  • Categorization of standardization efforts into quality documentation and general standard proposals.
  • Analysis of initiatives focusing on upstream processes, downstream data handling, processing, and storage.

Main Results:

  • Standardization efforts encompass quality documentation (technical notes, accreditation checklists, validation guidelines) and general standard proposals with quality metrics.
  • Focus is placed on upstream processes within the sequencing workflow, with discussions on downstream data handling, processing, and storage.
  • Current initiatives aim to establish a foundation for the prospective implementation of NGS in critical areas like clinical diagnostics.

Conclusions:

  • Standardization efforts are crucial for ensuring the reliability and reproducibility of DNA sequencing data.
  • These initiatives are foundational for the successful integration of NGS into clinical diagnostics and other high-stakes applications.
  • Continued development in standardization will significantly influence the traceability and overall quality of sequence data.