Scribd Logo
Upload

Welcome to Scribd!

  • 11 views

    Georgirene D. Vladutiu, PH.D

    Uploaded by

    fdablog
    This document discusses compliance requirements for biochemical genetic laboratories, including CLIA certification and proficiency testing. It notes that biochemical genetic testing has unique aspects compared to DNA testing and requires specialized interpretation. New guidelines have been released for biochemical and molecular genetic laboratories. The document also discusses concerns about FDA oversight of laboratory developed tests, including ensuring they are properly validated. It argues that risk-based oversight is needed and that increased regulation could increase costs and decrease access to biochemical genetic testing services.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPS, PDF, TXT or read online from Scribd
    Flag for inappropriate content

    You might also like

    Georgirene D. Vladutiu, PH.D

    Uploaded by

    fdablog
    11 views8 pages
    This document discusses compliance requirements for biochemical genetic laboratories, including CLIA certification and proficiency testing. It notes that biochemical genetic testing has unique aspects compared to DNA testing and requires specialized interpretation. New guidelines have been released for biochemical and molecular genetic laboratories. The document also discusses concerns about FDA oversight of laboratory developed tests, including ensuring they are properly validated. It argues that risk-based oversight is needed and that increased regulation could increase costs and decrease access to biochemical genetic testing services.

    Original Description:

    Original Title

    FDA-2010-N-0274-0054.2

    Copyright

    © Attribution Non-Commercial (BY-NC)

    Available Formats

    PPS, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    This document discusses compliance requirements for biochemical genetic laboratories, including CLIA certification and proficiency testing. It notes that biochemical genetic testing has unique aspects compared to DNA testing and requires specialized interpretation. New guidelines have been released for biochemical and molecular genetic laboratories. The document also discusses concerns about FDA oversight of laboratory developed tests, including ensuring they are properly validated. It argues that risk-based oversight is needed and that increased regulation could increase costs and decrease access to biochemical genetic testing services.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPS, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pps, pdf, or txt
    11 views8 pages

    Georgirene D. Vladutiu, PH.D

    Uploaded by

    fdablog
    This document discusses compliance requirements for biochemical genetic laboratories, including CLIA certification and proficiency testing. It notes that biochemical genetic testing has unique aspects compared to DNA testing and requires specialized interpretation. New guidelines have been released for biochemical and molecular genetic laboratories. The document also discusses concerns about FDA oversight of laboratory developed tests, including ensuring they are properly validated. It argues that risk-based oversight is needed and that increased regulation could increase costs and decrease access to biochemical genetic testing services.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPS, PDF, TXT or read online from Scribd
    Flag for inappropriate content
    Download as pps, pdf, or txt
    of 8

    Georgirene D. Vladutiu, Ph.D.

    Departments of Pediatrics, Neurology,

    and Pathology & Anatomical Sciences

    School of Medicine & Biomedical Sciences

    University at Buffalo

    Director, The Robert Guthrie

    Biochemical & Molecular Genetics Laboratory

    Kaleida Health Laboratories


    Compliance Requirements
    for Biochemical Genetic Laboratories
     CLIA certification
     Frequent proficiency testing & multiple
    programs (CAP, and others)
     Quality control program
     Accredited personnel (see CLIAC guidelines)
     Genetic counseling required for positive
    results (NYSDOH)
    Uniqueness of Biochemical
    Genetic Testing
     Specialized testing by few labs
     Biochemical testing not equal to
    DNA testing
     Strategies to regulate DNA testing
    not adequate for biochemical testing
     FDA’s definition of genetic testing
    appears to include both
    LDT Testing: FDA Concerns
    Diagnostic tests play increasing role
    in clinical decision-making; may not
    be properly validated for their intent

    Diagnostic test development may


    not provide reasonable assurance of
    safety and effectiveness
    New Guidelines for Clinical
    Biochemical and Molecular
    Genetics Laboratories
     Biochemical:
    http://wwwn.cdc.gov/cliac/pdf/Addenda/cliac0
    210/Addendum%20O.pdf
     Molecular:
    http://www.cdc.gov/mmwr/pdf/rr/rr5806.pdf
    LDT Testing: FDA Concerns
    Many publicly traded corporations using
    complex tests and algorithms physicians may
    not understand
     FDA should define types of laboratories and tests
    for potential new oversight
     Biochemical genetic testing requires detailed
    interpretation of results
     Qualified personnel are available for clarification
    Risk-Based Application of Oversight

     Measure of risk will depend on


     Test setting (prenatal, neonatal, adult)
     Predicted outcomes (not actual tests
    performed)
     Tolerance of risk will depend on
     Testing in response to symptomatic vs.
    presymptomatic purpose
    Impact of New Oversight on
    Biochemical Genetic Testing

     Cost of test development will increase


     Disincentive to innovative
     Healthcare costs will increase
     Access to services will further decrease

    You might also like