Location via proxy:   [ UP ]  
[Report a bug]   [Manage cookies]                
Scribd Logo
Upload

Welcome to Scribd!

  • 30 views

    FDA/CDHR Public Meeting: Oversight of Laboratory Developed Tests (Direct-to-Consumer Testing)

    Uploaded by

    fdablog
    The document discusses direct-to-consumer (DTC) genetic testing and the American Society for Clinical Pathology's (ASCP) concerns. The ASCP believes that for optimal patient health outcomes, patients who receive DTC tests should review results with their physicians and use CLIA-certified laboratories. An appropriate regulatory framework is needed to protect patients while encouraging testing innovation. All medical tests, regardless of complexity, should undergo review before patient use.

    Copyright:

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

    FDA/CDHR Public Meeting: Oversight of Laboratory Developed Tests (Direct-to-Consumer Testing)

    Uploaded by

    fdablog
    30 views9 pages
    The document discusses direct-to-consumer (DTC) genetic testing and the American Society for Clinical Pathology's (ASCP) concerns. The ASCP believes that for optimal patient health outcomes, patients who receive DTC tests should review results with their physicians and use CLIA-certified laboratories. An appropriate regulatory framework is needed to protect patients while encouraging testing innovation. All medical tests, regardless of complexity, should undergo review before patient use.

    Original Title

    FDA-2010-N-0274-0063.2

    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?

    The document discusses direct-to-consumer (DTC) genetic testing and the American Society for Clinical Pathology's (ASCP) concerns. The ASCP believes that for optimal patient health outcomes, patients who receive DTC tests should review results with their physicians and use CLIA-certified laboratories. An appropriate regulatory framework is needed to protect patients while encouraging testing innovation. All medical tests, regardless of complexity, should undergo review before patient use.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPS, PDF, TXT or read online from Scribd
    Download as pps, pdf, or txt
    30 views9 pages

    FDA/CDHR Public Meeting: Oversight of Laboratory Developed Tests (Direct-to-Consumer Testing)

    Uploaded by

    fdablog
    The document discusses direct-to-consumer (DTC) genetic testing and the American Society for Clinical Pathology's (ASCP) concerns. The ASCP believes that for optimal patient health outcomes, patients who receive DTC tests should review results with their physicians and use CLIA-certified laboratories. An appropriate regulatory framework is needed to protect patients while encouraging testing innovation. All medical tests, regardless of complexity, should undergo review before patient use.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPS, PDF, TXT or read online from Scribd
    Download as pps, pdf, or txt
    of 9

    FDA/CDHR Public Meeting:

    Oversight of Laboratory Developed Tests


    (Direct-to-Consumer Testing)

    Kenneth Emancipator, MD, FASCP


    Officer and Member of the ASCP Executive Committee
    July 19-20, 2010
    Direct-to-Consumer Testing
    (DTC)

     DTC, particularly as it relates to genetic


    testing, is an area of growing concern to
    the American Society for Clinical Pathology
    (ASCP).

     ASCP is a patient-centered organization


    committed to optimizing patient health
    outcomes.
    To Ensure Optimal Health Outcomes:

     Patients choosing DTC tests marketed and sold in DTC


    commercial transactions should review results with their
    physicians and utilize CLIA certified laboratories.

     Appropriate regulatory framework for DTC testing must


    simultaneously protect patient health while fostering an
    environment that encourages the innovation of more advanced
    testing technology.

     All test devices, regardless of their level of complexity or of the


    qualifications of person performing the test, should be
    reviewed before their use on or by patients.

     Claims of clinical validity for all testing devices should be


    established in an environment similar to that which they are
    intended.
    Direct-to-Consumer: A New Paradigm
     Traditionally, physicians have been responsible
    for ordering diagnostic tests on their patients.

     Today, the rapid developments in genetic testing


    technology and the emergence of personal
    genome testing companies have created
    increasing opportunity for patients to become
    more involved in their health care.

     Proponents of DTC testing argue that it provides


    patients risk assessment information and allows
    patients to proactively search for specific genetic
    variants of interest.
    Direct-to-Consumer Issues
     DTC presents a myriad of issues, not only for patients,
    but also for clinical laboratories, physicians, and
    insurance companies.

     Issues include, but are not limited to:


    • Medical implications such as patient understanding of
    the test results.
    • The analytic validity, clinical validity, and clinical utility
    of the DTC genetic tests in the market today.
    • The legal implications and liability of DTC testing.

     Concern: DTC testing will generate undue stress and


    the “worried well” – individuals who over-interpret their
    test results.
    ASCP Recommendations

     Laboratories performing DTC should provide


    patients undergoing testing with easy to
    comprehend test results.
    • Make available to the patient pre-testing information
    (e.g., the need for fasting, eating or drinking, effect of
    specific medications, etc.)

     For optimum patients health outcomes,


    patients should consult with their physician for
    proper interpretation of the test results.
    • Clinicians may have access to the patient’s family
    history and other data that can critically affect test
    interpretation.
    DTC Clinical Value

     Currently, the clinical value of most DTC


    genetic tests remain unproven.
    • The presence of particular genomic variant in a
    given individual, though statistically significant,
    may not necessarily mean that it is clinically
    meaningful.
    • There are little or no data on the outcomes of
    these tests.
     Laws and regulations regarding DTC testing
    vary by state, therefore, each laboratory
    performing such tests must operate in
    accordance with federal and state law.
     ASCP believes that it is important for
    physicians and patients to use DTC test
    results as a mechanism to discuss a
    variety of health-related issues and future
    laboratory testing needs if necessary.

     It is essential that patients who choose to


    engage in DTC testing select a CLIA
    certified laboratory and have their test
    results reviewed by their primary care
    physician.
    Thank You.

    You might also like