NOV 08, 2017 1:30 PM PST

Guiding Clinical Laboratory Integration of Next-Generation Sequencing to Assure Quality Testing

Speaker
  • Senior Project Lead, Geneticist at the Centers for Disease Control and Prevention
    Biography
      Dr. Ira M. Lubin is a senior scientist within the Division of Laboratory Systems at the Centers for Disease Control and Prevention. He is Clinical Molecular Geneticist certified by the American Board of Medical Genetics. Dr. Lubin has led or otherwise participated in both national and international efforts to advance the quality of laboratory practice during his 18-year tenure at CDC, working extensively with federal, academic, and commercial partners. In 2010, he next-generation sequencing (NGS) was added to his list of interests. He helped to initiate and co-lead the Next-Generation Sequencing: Standards for Clinical Testing (Nex-SToCT) series of national workgroups that culminated in three consensus guidance documents that served to inform evolving practices and standards both domestically and globally. Dr. Lubin co-Chaired the Clinical and Laboratory Standards Institute Document Development Committee that produced the guideline - Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine that provided significant attention to NGS. He has provided input to the evolving FDA framework for NGS by serving as an invited presenter at several workshops. He has also presented to the Clinical Laboratory Improvement Amendments in providing input relevant to the oversight of NGS implemented in clinical laboratory settings. Internationally, Dr. Lubin has been an invited presenter to the European clinical laboratory community and participated in the review of NGS guidelines developed by EuroGenTest.

    Abstract

    The integration of next-generation sequencing (NGS) tests into clinical laboratory practice across medical disciplines provides medically actionable data that in some cases are not otherwise attainable.  This presentation will describe evolving guidance and private/public funded initiatives developed to promote the effective and safe use of NGS for patient care.  Integration of NGS into clinical laboratory practice created novel challenges and approaches for test validation, quality assurance, result interpretation, reporting, and compliance with regulatory requirements.   Data analysis, storage, and medical coding presents other challenges that require significant informatics expertise not traditionally a component of laboratory practice.  The capability to sequence the human genome, pathogens, and the human microbiome provides the opportunity to collect data having immediate and potentially future clinical relevance, blurring the line between medical and research applications.  In some instances, the laboratory assumes an enhanced consultative role to advise clinicians about test selection, variant interpretation, and the limitations of NGS; knowledge required to inform clinical decision-making.  This professional consultative role is essential toward assuring appropriate test utilization and as a resource for clinicians who are less familiar with NGS and do not have the time to establish and maintain expertise in this rapidly evolving area of laboratory medicine.


    Show Resources
    You May Also Like
    DEC 15, 2020 10:00 AM PST
    C.E. CREDITS
    DEC 15, 2020 10:00 AM PST
    DATE: December 15, 2020 TIME: 10:00am PST Scientists from Thermo Fisher Scientific will walk us through the world of microorganisms. They will discuss their most recent research on viruses,...
    APR 01, 2021 8:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    APR 01, 2021 8:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    Date: April 01, 2021 Time: 8:00am (PST), 11:00am (EST) Generating therapeutic antibodies is far more challenging than obtaining antibodies that merely recognize their targets. Engineering po...
    APR 20, 2021 11:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    APR 20, 2021 11:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    Date: April 20, 2021 Time: 11:00am (PST), 2:00pm (EST) Identification and confirmation of microbial isolates is crucial in the analysis workflow, providing decision-makers the information...
    MAR 25, 2021 8:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    C.E. CREDITS
    MAR 25, 2021 8:00 AM PDT
    Add to Calendar Select one of the following: iCal Google Calendar Outlook Calendar Yahoo Calendar
    Date: March 25, 2021 Time: 8:00am (PST), 11:00am (EST) Flow cytometry has expanded to have more users, more data, and multiple instrument types. While this has lead to more quantitative data...
    DEC 02, 2020 8:00 AM PST
    C.E. CREDITS
    DEC 02, 2020 8:00 AM PST
    DATE: December 2nd, 2020 TIME: 08:00am PDT, 11:00pm EDT Bioreactors and shakers are used to cultivate microorganisms, plant, insect, and mammalian cells in different volumes. Upscaling of pr...
    NOV 16, 2020 8:00 AM PST
    C.E. CREDITS
    NOV 16, 2020 8:00 AM PST
    Date: November 16, 2020 Time: 8:00am (PST), 11:00am (EST) CRISPR screening has become the prime discovery tool in modern biomedical research and drug discovery. At the same time, most screen...
    NOV 08, 2017 1:30 PM PST

    Guiding Clinical Laboratory Integration of Next-Generation Sequencing to Assure Quality Testing


    Specialty

    Molecular Biology

    Genomics

    Precision Medicine

    Molecular Diagnostics

    Mass Spectrometry

    Genotyping

    Biomarkers

    Pcr/rt-Pcr/real-Time Pcr

    Next-Generation Sequencing

    University

    Assay Development

    Chromatography

    Proteomics

    Lims

    Cancer Therapeutics

    Geography

    North America33%

    Asia33%

    Africa33%

    Registration Source

    Website Visitors100%

    Job Title

    Medical Laboratory Technician67%

    Medical Doctor/Specialist33%

    Organization

    Clinical Laboratory33%

    Hospital33%

    Manufacturer - Other33%


    Show Resources
    Loading Comments...
    Show Resources
    Attendees
    • See more