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    FDA/CDRH Public Meeting: Oversight of Laboratory Developed Tests - Patient Considerations

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    fdablog
    This document summarizes Genentech's position on the oversight of laboratory developed tests (LDTs). Genentech argues that LDTs should be regulated by the FDA to ensure patient safety, as some LDTs make claims and guide treatment without evidence review. Specifically, LDTs put patients at risk of receiving inappropriate treatment or not receiving needed treatment. Genentech proposes a risk-based FDA framework to regulate LDTs and validate their clinical utility, in order to advance personalized healthcare safely.

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    FDA/CDRH Public Meeting: Oversight of Laboratory Developed Tests - Patient Considerations

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    fdablog
    23 views8 pages
    This document summarizes Genentech's position on the oversight of laboratory developed tests (LDTs). Genentech argues that LDTs should be regulated by the FDA to ensure patient safety, as some LDTs make claims and guide treatment without evidence review. Specifically, LDTs put patients at risk of receiving inappropriate treatment or not receiving needed treatment. Genentech proposes a risk-based FDA framework to regulate LDTs and validate their clinical utility, in order to advance personalized healthcare safely.

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    FDA-2010-N-0274-0030.1

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    This document summarizes Genentech's position on the oversight of laboratory developed tests (LDTs). Genentech argues that LDTs should be regulated by the FDA to ensure patient safety, as some LDTs make claims and guide treatment without evidence review. Specifically, LDTs put patients at risk of receiving inappropriate treatment or not receiving needed treatment. Genentech proposes a risk-based FDA framework to regulate LDTs and validate their clinical utility, in order to advance personalized healthcare safely.

    Copyright:

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

    FDA/CDRH Public Meeting: Oversight of Laboratory Developed Tests - Patient Considerations

    Uploaded by

    fdablog
    This document summarizes Genentech's position on the oversight of laboratory developed tests (LDTs). Genentech argues that LDTs should be regulated by the FDA to ensure patient safety, as some LDTs make claims and guide treatment without evidence review. Specifically, LDTs put patients at risk of receiving inappropriate treatment or not receiving needed treatment. Genentech proposes a risk-based FDA framework to regulate LDTs and validate their clinical utility, in order to advance personalized healthcare safely.

    Copyright:

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

    FDA/CDRH Public Meeting

    Oversight of
    Laboratory Developed Tests -
    Patient Considerations

    Genentech
    A Member of the Roche Group
    July 19, 2010
    1
    Overview

    • Genentech’s position on personalized


    healthcare (PHC) and patient health & safety

    • Genentech’s Citizen Petition: Regulation of In


    Vitro Diagnostic (IVD) Tests

    • IVD tests and patient safety

    • Conclusions
    2
    Genentech’s Position on Personalized
    Healthcare and Patient Health and Safety
    • Personalized healthcare (PHC)
    – RIGHT drug to the RIGHT patient
    – An integral part of our strategy is to provide patients with safe,
    efficacious, clinically differentiated medicines.
    – IVD assays that provide information at a molecular level are key
    to PHC.

    • In the context of PHC, patient health and safety depend on:


    – A thorough evaluation of the safety and efficacy of the medicines
    used to treat patients
    – Combined with appropriate assessment of the accuracy and
    clinical utility of all IVD tests that significantly inform prescribing
    of drugs.

    3
    Genentech’s Citizen Petition
    • In Dec. 2008, Genentech submitted a Citizen Petition to FDA which set
    forth:
    – Patient-focused reasons why FDA should exercise its regulatory
    authority over all IVD tests.
    • Some LDTs are entering the market without review of the
    evidence for claims made to support their use in patient care.

    – Framework for using the FDA’s current risk-based classification


    system for necessary and appropriate review of LDTs
    • Should be calibrated to the risk posed by the test, so that it
    does not stifle innovation in PHC.
    • All claims should be scientifically validated and reviewed by FDA
    to ensure that health care professionals and patients have
    access to validated diagnostics to help guide their therapeutic
    decision-making.

    4
    Diagnostic Tests and Patient Safety

    • Without appropriate regulation of all IVD tests, patients


    are at risk.

    • Use of diagnostic tests that make unsubstantiated claims


    intended to guide specific therapeutic decision-making
    threatens patient health and safety.

    • Potential risks to patient health and safety include:


    – Patients receiving inappropriate treatment (thus
    exposing them to unnecessary side effects or possible
    treatment failure)
    – Patients not receiving appropriate treatment.
    5
    Diagnostic Tests and Patient Safety
    (cont’d)
    • Regulation of LDTs should be comprehensive including :
    – Analytical and clinical performance
    – Monitoring of test performance in order to protect
    patients (e.g., through post marketing surveillance
    and medical device reporting).
    • Example: Patient test recall in Jan. 2009 for
    possibly inaccurate LDT Vitamin D testing
    affecting thousands of patients who were tested
    over two years

    6
    Genentech’s Continued Concern:
    Our Patients
    • Today, LDTs continue to enter the market without sufficient review
    of scientific or clinical evidence for claims made to support their
    use in patient care.
    – LDT manufacturers promote their tests without FDA regulatory oversight.
    – LDT manufacturers promote responsiveness to therapies without FDA review
    of data.

    • In contrast, a Genentech-identified biomarker which predicts


    responsiveness to therapy would require full regulatory review prior
    to approval of the test, inclusion in labeling and any promotion or
    use.

    • Genentech is concerned that the current environment is unsafe for


    patients and possibly creates situations that could result in
    inappropriate treatment.

    7
    Conclusions
    • With a focus on PHC, diagnostic tests play an
    increasingly important role in clinical decision making
    and disease management.

    • LDTs that have not been properly validated for their


    intended use put patients at risk.

    • Patient risks include failure to receive appropriate


    treatment, and/or receive inappropriate treatment.

    • A risk-based application of FDA oversight to LDTs is the


    appropriate approach to achieve the desired public
    health benefit.
    8

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