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.


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