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    Fda Regulation: Lab Developed Tests (LDTS) : Ted Snelgrove

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    fdablog
    This document discusses key issues regarding FDA regulation of Lab Developed Tests (LDTs). It notes that both absolute and relative risk are important for FDA to consider when evaluating new tests. When regulating LDTs, the FDA should specify intended use, analytic validity, and clinical validity. The FDA's approach also needs to expand its expertise to appropriately regulate personalized genetic tests, which characterize individual disease variations. Overall, the document argues that the FDA's approach to regulating LDTs needs to recognize key differences between diagnostics and other medical products in order to not stifle innovation.

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    Fda Regulation: Lab Developed Tests (LDTS) : Ted Snelgrove

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    fdablog
    13 views6 pages
    This document discusses key issues regarding FDA regulation of Lab Developed Tests (LDTs). It notes that both absolute and relative risk are important for FDA to consider when evaluating new tests. When regulating LDTs, the FDA should specify intended use, analytic validity, and clinical validity. The FDA's approach also needs to expand its expertise to appropriately regulate personalized genetic tests, which characterize individual disease variations. Overall, the document argues that the FDA's approach to regulating LDTs needs to recognize key differences between diagnostics and other medical products in order to not stifle innovation.

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    FDA-2010-N-0274-0052.1

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    This document discusses key issues regarding FDA regulation of Lab Developed Tests (LDTs). It notes that both absolute and relative risk are important for FDA to consider when evaluating new tests. When regulating LDTs, the FDA should specify intended use, analytic validity, and clinical validity. The FDA's approach also needs to expand its expertise to appropriately regulate personalized genetic tests, which characterize individual disease variations. Overall, the document argues that the FDA's approach to regulating LDTs needs to recognize key differences between diagnostics and other medical products in order to not stifle innovation.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    13 views6 pages

    Fda Regulation: Lab Developed Tests (LDTS) : Ted Snelgrove

    Uploaded by

    fdablog
    This document discusses key issues regarding FDA regulation of Lab Developed Tests (LDTs). It notes that both absolute and relative risk are important for FDA to consider when evaluating new tests. When regulating LDTs, the FDA should specify intended use, analytic validity, and clinical validity. The FDA's approach also needs to expand its expertise to appropriately regulate personalized genetic tests, which characterize individual disease variations. Overall, the document argues that the FDA's approach to regulating LDTs needs to recognize key differences between diagnostics and other medical products in order to not stifle innovation.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
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    FDA Regulation:

    Lab Developed Tests (LDTs)

    Ted Snelgrove
    Chief Commercial Officer
    Crescendo Bioscience
    July 20, 2010
    LDT Oversight Issues

    1. Risk Assessments

    2. Intended Use Claims & Test Interpretation

    3. FDA Approach to PGx Field


    Oversight Issue #1:
    Risk Assessment

    • Both absolute & relative risk are important for FDA to consider
    when evaluating new tests
    • It is important to recognize that test results include analytical
    validity set by the laboratory performing the test as well as the
    clinical meaning of the analytical result; analytical validity may
    not be transferred easily from one lab to another
    • Information is a different kind of product with different risks
    meriting a specialized rule set
    Oversight Issue #2:
    Intended Use Claims & Test Interpretation

    • Claims for assays should specify the following:


    – Intended Use Population
    – Analytic Validity
    – Clinical Validity

    • Testing in other experimental settings should be not be prohibited


    as long as the results are also considered experimental
    • Under CLIA, labs are required to share all the data they have to
    support interpretation in individual cases – FDA rules should not
    interfere with current CLIA requirements for these consultations
    Oversight Issue #3:
    FDA Approach to the PGx Field
    • Companies in this field need to be able to plan with a firm
    understanding of the rules that will apply
    – Clarity and consistency are needed
    – Lead-times afforded under any new rules should match the
    operational needs of industry participants for reasonable compliance
    • FDA skill & expertise needs to expand to meet the challenges
    posed by these new technologies
    – Drug & device experts may not always have the requisite skills
    – Optimal statistical methods may come from outside health care
    – Systems designed to regulate products across populations that are
    considered homogeneous may not be appropriate for products that
    are intended to characterize individual variations of disease
    Summary
    • Important to recognize critical differences between diagnostics and devices
    generally and between LDTs and other in vitro diagnostics specifically

    • Being sensitive to the differences that distinguish the insights generated by


    PGx products from the nuts & bolts of tangible products is very important
    – Intended use claims should not be constrained in ways that interfere with the
    medically necessary flow of clinical information between labs and clinicians in the
    practice of laboratory medicine

    • FDA needs to evolve along with industry – industry should not be expected
    to reconfigure innovative diagnostic solutions to fit traditional FDA
    regulatory models

    Thank you for the opportunity to present my views

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