Webinar Series: Establishing Molecular Tests in Clinical Labs

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The Simple, Sensible, Salient & Still Spell-Binding Seven Questions about Laboratory Developed Tests

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    WF24275-Speaker-Mara

    Mara G. Aspinall
    Managing Director, Health Catalysts Group, Professor of Practice, Biomedical Diagnostics, Arizona State University


    Challenges of Establishing Laboratory-Developed Tests

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      WF24275-Speaker-Vijay

      Dr. Vijay Singh
      Director of Molecular Diagnostics,
      HealthTrackRx


      Explore additional educational resources:

      WF24247-educational-paper

      Educational paper: An introduction to diagnostic testing in laboratories

      In this overview, we describe different diagnostic assays and explain why they are important for laboratories in various settings. We discuss potential areas for growth in the use of laboratory developed tests, as well as what a laboratory must do to implement one. We also describe more traditional IVD tests that are approved by the U.S. Food and Drug Administration (FDA), the role of IVD tests in the U.S. healthcare system, and some of the potential benefits associated with them. Finally, we review regulations that that must be understood by IVD manufacturers and laboratories that offer LDTs.

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      WF24129-white-paper-pathogen-detection-solutions

      Using molecular panels to help manage infectious disease: update on lab trends and health outcomes

      Learn about the different testing methods used by laboratory managers and the advantages of molecular techniques in areas including respiratory, gastrointestinal, and genitourinary conditions to improve overall outcomes.

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