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    FDA Oversight of Laboratory Developed Tests Docket Number FDA-2010-N-0274

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    The Greenwood Genetic Center provides genetic testing for over 350 rare genetic disorders through their diagnostic laboratories. The majority of these tests are laboratory developed tests since FDA approved tests are not available for most rare conditions. The Center adheres to the highest quality standards established by CLIA and is working towards CAP certification. However, additional FDA regulation of laboratory developed tests could limit patient access to crucial testing and hinder test development for rare disorders due to increased time and costs. Instead of redundant oversight, the FDA should work with CMS and CAP to improve existing programs, establish a national test registry, and directly address specific companies making questionable claims rather than imposing burdensome regulation on all laboratories.

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    FDA Oversight of Laboratory Developed Tests Docket Number FDA-2010-N-0274

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    fdablog
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    The Greenwood Genetic Center provides genetic testing for over 350 rare genetic disorders through their diagnostic laboratories. The majority of these tests are laboratory developed tests since FDA approved tests are not available for most rare conditions. The Center adheres to the highest quality standards established by CLIA and is working towards CAP certification. However, additional FDA regulation of laboratory developed tests could limit patient access to crucial testing and hinder test development for rare disorders due to increased time and costs. Instead of redundant oversight, the FDA should work with CMS and CAP to improve existing programs, establish a national test registry, and directly address specific companies making questionable claims rather than imposing burdensome regulation on all laboratories.

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    FDA-2010-N-0274-0082.1

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    The Greenwood Genetic Center provides genetic testing for over 350 rare genetic disorders through their diagnostic laboratories. The majority of these tests are laboratory developed tests since FDA approved tests are not available for most rare conditions. The Center adheres to the highest quality standards established by CLIA and is working towards CAP certification. However, additional FDA regulation of laboratory developed tests could limit patient access to crucial testing and hinder test development for rare disorders due to increased time and costs. Instead of redundant oversight, the FDA should work with CMS and CAP to improve existing programs, establish a national test registry, and directly address specific companies making questionable claims rather than imposing burdensome regulation on all laboratories.

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    24 views2 pages

    FDA Oversight of Laboratory Developed Tests Docket Number FDA-2010-N-0274

    Uploaded by

    fdablog
    The Greenwood Genetic Center provides genetic testing for over 350 rare genetic disorders through their diagnostic laboratories. The majority of these tests are laboratory developed tests since FDA approved tests are not available for most rare conditions. The Center adheres to the highest quality standards established by CLIA and is working towards CAP certification. However, additional FDA regulation of laboratory developed tests could limit patient access to crucial testing and hinder test development for rare disorders due to increased time and costs. Instead of redundant oversight, the FDA should work with CMS and CAP to improve existing programs, establish a national test registry, and directly address specific companies making questionable claims rather than imposing burdensome regulation on all laboratories.

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    FDA Oversight of Laboratory Developed Tests

    Docket Number FDA-2010-N-0274

    Comments submitted on behalf of the Greenwood Genetic Center by


    Julie R. Jones, PhD, FACMG
    Director, Molecular Diagnostic Laboratory
    Greenwood Genetic Center
    Greenwood, SC

    The Greenwood Genetic Center (GGC) is a nonprofit institute, organized to provide


    comprehensive genetic services. Since 1974, the Greenwood Genetic Center has been a leader in
    the delivery of genetic services, committed to diagnosing genetic conditions, counseling
    individuals and families, researching the causes of birth defects and genetic diseases, and
    educating health care providers, teachers, and the public about genetics.

    The Biochemical, Cytogenetic, and Molecular Diagnostic Laboratories at the Greenwood


    Genetic Center provide genetic testing for over 350 rare genetic disorders. The vast majority of
    these analyses are laboratory developed tests (LDTs) since FDA cleared or approved tests are not
    available for most of these rare genetic conditions. Our patients rely heavily on LDTs for
    diagnosis, preventative care, treatment (including monitoring efficacy), and family planning.
    The Directors of the Diagnostic Laboratories at GGC are certified by the American Board of
    Medical Genetics and have had extensive training in assay design and development,
    interpretation of test results, and the implementation and maintenance of quality control and
    quality assurance programs and are, thus, well qualified to develop and offer LDTs as part of our
    genetic services.

    We fully understand the FDA’s concerns regarding the analytic and clinical validity of
    laboratory developed tests. The GGC Diagnostic Laboratories adhere to the highest standards
    established by the Clinical Laboratory Improvement Amendments (CLIA) and the American
    College of Medical Genetics, and for the past four years our laboratories have been working
    toward implementing all of the practices and documentation required for certification by the
    College of American Pathologists (CAP). While CLIA focuses on the overall quality of the
    laboratory, CAP not only assesses the overall management and operation of the laboratory, it
    also has strict requirements for the analytic validity of every test offered by the lab as well as the
    implementation of comprehensive quality control and quality assurance programs including
    mandatory proficiency testing. We understand firsthand the tremendous amount of time and
    effort required to be in compliance with both CLIA and CAP guidelines, but we are fully
    committed to meet and maintain the highest standards in order to provide the best possible care
    for our patients.

    The ultimate goal of GGC, as well as the FDA, is to provide the highest quality healthcare to our
    patients. One of our greatest concerns regarding oversight of LDTs by the FDA is that additional
    regulations and requirements would be so time consuming and financially burdensome it would
    result in fewer tests being offered and, therefore, limit patient access to crucial testing. It would
    also likely hinder test development, especially for those tests designed to diagnose rare genetic
    disorders. Most of the genetic testing for rare and ultra rare genetic disorders are performed by
    relatively small private companies or diagnostic laboratories at academic institutions, and the
    majority of these laboratories do not have the financial resources necessary to submit 510(k)
    applications to the FDA, and larger private companies are not interested in developing tests for
    rare conditions because it would not be profitable for them to do so. While the intent of the FDA
    in considering oversight of LDTs is to ensure quality and safety, the action may inadvertently
    have the opposite effect if not implemented appropriately.

    In order to continue to provide high quality healthcare to individuals with rare genetic disorders
    and to prevent redundancy in the system, we would like to recommend the following:

    1) The FDA should work closely with the Centers for Medicare and Medicaid Services (CMS)
    and CAP to understand the extensive level of oversight currently in place and to improve these
    existing programs rather than the FDA create an entirely new and independent system of
    oversight for LDTs.

    2) Since CLIA and CAP do not address clinical validity of genetic testing, we recommend
    establishing a national mandatory test registry where all genetic diagnostic laboratories would be
    required to list all of the tests being offered. This registry would enhance transparency regarding
    clinical validity.

    3) If the FDA has concerns regarding a specific company’s claims about the clinical validity or
    utility of a genetic test, the FDA should address that specific company directly and require the
    company to provide evidence for those claims. It would be much more effective for the FDA to
    directly confront those individual companies who are engaging in questionable practices than for
    the FDA to impose redundant and burdensome oversight on all laboratories.

    4) Finally, we recommend that direct to consumer testing be subjected to a completely separate


    system of oversight (or at least to supplemental regulations) since these tests pose additional
    concerns as highlighted in recent congressional hearings.

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