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    FDA Public Meeting On Laboratory Developed Tests July 19, 2010

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    The American Association for Clinical Chemistry (AACC) supports the FDA's goals of ensuring accurate and accessible patient testing while recognizing the challenges of regulating laboratory developed tests (LDTs). AACC believes that LDTs are already subject to rigorous oversight through the Clinical Laboratory Improvement Amendments (CLIA) program and independent accrediting bodies. AACC supports a risk-based approach where high risk LDTs are regulated by the FDA and low to moderate risk LDTs continue to be regulated by CLIA, with most LDTs expected to fall into the low to moderate risk categories. AACC also recommends a special exception for orphan tests to encourage development of tests for rare diseases.

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    FDA Public Meeting On Laboratory Developed Tests July 19, 2010

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    fdablog
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    The American Association for Clinical Chemistry (AACC) supports the FDA's goals of ensuring accurate and accessible patient testing while recognizing the challenges of regulating laboratory developed tests (LDTs). AACC believes that LDTs are already subject to rigorous oversight through the Clinical Laboratory Improvement Amendments (CLIA) program and independent accrediting bodies. AACC supports a risk-based approach where high risk LDTs are regulated by the FDA and low to moderate risk LDTs continue to be regulated by CLIA, with most LDTs expected to fall into the low to moderate risk categories. AACC also recommends a special exception for orphan tests to encourage development of tests for rare diseases.

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    FDA-2010-N-0274-0040.1

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    The American Association for Clinical Chemistry (AACC) supports the FDA's goals of ensuring accurate and accessible patient testing while recognizing the challenges of regulating laboratory developed tests (LDTs). AACC believes that LDTs are already subject to rigorous oversight through the Clinical Laboratory Improvement Amendments (CLIA) program and independent accrediting bodies. AACC supports a risk-based approach where high risk LDTs are regulated by the FDA and low to moderate risk LDTs continue to be regulated by CLIA, with most LDTs expected to fall into the low to moderate risk categories. AACC also recommends a special exception for orphan tests to encourage development of tests for rare diseases.

    Copyright:

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    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    21 views3 pages

    FDA Public Meeting On Laboratory Developed Tests July 19, 2010

    Uploaded by

    fdablog
    The American Association for Clinical Chemistry (AACC) supports the FDA's goals of ensuring accurate and accessible patient testing while recognizing the challenges of regulating laboratory developed tests (LDTs). AACC believes that LDTs are already subject to rigorous oversight through the Clinical Laboratory Improvement Amendments (CLIA) program and independent accrediting bodies. AACC supports a risk-based approach where high risk LDTs are regulated by the FDA and low to moderate risk LDTs continue to be regulated by CLIA, with most LDTs expected to fall into the low to moderate risk categories. AACC also recommends a special exception for orphan tests to encourage development of tests for rare diseases.

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    FDA Public Meeting on Laboratory Developed Tests

    July 19, 2010

    My name is Bill Clarke and I am here today representing the American Association for

    Clinical Chemistry. AACC is the principal association of professional laboratory scientists--

    including MDs, PhDs and medical technologists. AACC’s members develop and use chemical

    concepts, procedures, techniques and instrumentation in health-related investigations and work in

    hospitals, independent laboratories and the diagnostics industry worldwide.

    AACC appreciates the opportunity to provide input to the FDA regarding the agency’s

    oversight of laboratory developed tests. We support the FDA’s dual goals of ensuring that

    patient testing is accessible and accurate. AACC recognizes the challenges the agency faces as it

    attempts to find the appropriate regulatory balance between patient protections and scientific

    innovation. We welcome the opportunity to work with you to develop policy in this uncharted

    territory.

    Although the purpose of this meeting is to discuss the appropriate level of FDA

    regulation of LDTs, we believe it’s important to acknowledge that these tests are already subject

    to vigorous public and private sector oversight. All laboratories performing LDTs are

    categorized as high complexity under the CLIA’88 and are therefore subject to stringent

    personnel, quality control, and proficiency testing standards, among others. In addition, CLIA
    laboratories must document the analytic validity of LDTs and make that information available to

    inspectors.

    Many of the laboratories conducting LDTs are also accredited by the College of

    American Pathologists, one of the leading private accrediting bodies in the nation. CAP requires

    testing facilities in their Laboratory Accreditation Program to demonstrate the analytic validity of

    LDTs as well as to document how they are clinically validated. There are also state requirements

    in place. For instance, the New York State Clinical Laboratory Evaluation Program requires

    laboratories to document analytic and clinical validity prior to introducing a test. These

    standards apply to all laboratories conducting testing on patient specimens derived from the state.

    Thus, AACC believes the regulatory gap that needs to be addressed is very narrow.

    AACC supports the FDA’s idea of employing a risk-based classification approach for

    determining the level of oversight for LDTs. We believe the categories within this scheme

    should be high, moderate and low with the degree of regulation associated with each category

    determined by the level of risk to the patient. An example of a high risk test would be an assay

    where clinical validity cannot be independently verified (for example, IVDMIAs). We urge you

    to consult clinical laboratorians as you construct any risk stratification scheme.

    Once risk stratification occurs, AACC recommends that high risk LDTs be subject to

    FDA oversight, whereas low and moderate risk LDTs should be regulated by CMS utilizing the

    CLIA’88 regulations. We believe it’s important to note that a test defined as high complexity

    under CLIA’88 is not necessarily high risk. In fact, we would expect the vast majority of LDTs,
    which are well characterized, to be associated with low to moderate risk. AACC also supports a

    special exception for orphan tests. Unless a limited exception or other accommodation is made,

    no one — neither a manufacturer or a clinical laboratory—will develop these critical tests for

    diagnosing and treating rare diseases.

    Thank you for the opportunity to offer our comments on this issue. AACC looks forward

    to working with you on this important issue.

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