OCT 22, 2019 10:00 AM PDT

Demystifying Analytical Validation While Onboarding NGS Tests

Speakers
  • Sr. Project Manager, Analytical Validation (AV) Consulting Services - Thermo Fisher Scientific
    Biography
      Geoffrey Bien is the senior project manager at Thermo Fisher Scientific for AV consulting services for Ion Torrent Oncomine products. In this role, Geoffrey consults with molecular testing labs on the AV process when onboarding new NGS assays. Geoffrey started his career in molecular diagnostics at Clarient (GE Healthcare/NeoGenomics) in Aliso Viejo, California, where he was responsible for the development and validation of allele-specific PCR and Sanger sequencing assays. In 2013, he joined Thermo Fisher and was part of the team that implemented NGS at the company's lab in West Sacramento, California. After a brief stint at an engineering firm, Geoffrey rejoined Thermo Fisher in his current role, where he has helped develop the current AV consulting services for NGS.
    • Coordinator, Molecular Biology Department - Alverno Laboratories
      Biography
        Leah Ames is a coordinator for the molecular biology department, and the lead medical laboratory scientist responsible for implementing NGS, at Alverno Laboratories in Hammond, Indiana. She has spent the last 13 years working in their molecular laboratory bringing new tests online, including the lab's recently implemented Ion Torrent Oncomine Myeloid Panel workflow. She holds a specialist certification in flow cytometry from the American Society for Clinical Pathology (ASCP) and is an adjunct professor in the laboratory science programs of multiple universities, focusing on professional collaboration, patient safety, and improving diagnostics in health care.

      Abstract

      DATE: October 22, 2019
      TIME: 10:00am PDT

      Next-generation sequencing (NGS) is quickly becoming the go-to tool for testing labs looking to bring on additional tests requiring smaller tissue samples, reduced time to results, and increased efficiencies and profitability. While these labs are faced with inherent challenges—such as staffing resources and competencies, testing volumes, and reimbursement—more and more are deciding that insourcing commercially available NGS tests is the way to go for the greatest return on investment. However, adapting to variability in the compliance environment, applying requirements to molecular assays, and knowing the documentation needed can pose additional risk. 

      In this webinar, you will hear about the importance of analytical validation (AV) in the process validation workflow when introducing NGS-based testing. An AV specialist will summarize the College of American Pathologists (CAP) checklist for NGS tests, the New York State Department of Health (NYSDOH) guidelines, and the importance of demonstrating utility as relating to the AV consulting services provided by Thermo Fisher Scientific. The webinar will cover the importance of using the CAP checklist and NYSDOH guidelines to aid in the launch of new molecular tests.   

      You’ll also hear from a scientist at a testing lab on the challenges and successes encountered when bringing NGS testing online, the role that AV consulting services from Thermo Fisher played in the overall process, and advice for other labs that are considering insourcing molecular testing assays.

       

      Learning Objectives:

      • Recognize the requirements outlined in the CAP checklist when onboarding new NGS tests
      • Disuss how Thermo Fisher Scientific aligns their AV consulting services to the CAP and NYSDOH guidelines
      • Discuss the challenges faced by molecular testing labs when bringing new tests online

       

      Webinars will be available for unlimited on-demand viewing after live event.

       

      LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing Education credit once you have viewed the webinar in its entirety.

       


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