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No. 4, 2011

LABORATORY BRANCH UPDATE

Advisory Panel Recommends Reclassification of Diagnostics for Tuberculosis

On June 29, 2011, the Food and Drug Administration (FDA) held a public meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. The purpose of the meeting was to discuss and make recommendations regarding the possible reclassification of molecular diagnostics for the rapid detection of M. tuberculosis complex and genetic mutations associated with antibiotic resistance, and for immunologically based tests such as interferon gamma release assays (IGRAs) that are intended for the detection of latent TB infection (LTBI) by indirect means.

The first nucleic acid amplification test (NAAT) for the detection of TB was approved in 1995; no additional applications have been submitted to FDA since 1994. The current class III designation requiring the most stringent regulatory controls has been seen as a deterrent by some experts for the development of new diagnostics for TB owing to additional regulatory requirements and greater oversight. After 15 years’ experience with molecular diagnostics for TB and substantial advances in technology, with CDC’s encouragement, FDA convened the meeting to hear discussion and receive recommendations to assess whether special controls could be written to mitigate the risks of an inaccurate test results.

The Microbiology Devices Panel consisted of six voting members, eight non-voting members, and one representative each for patients, industry, and consumers. Dr. Steven Gitterman of FDA explained the reclassification process and current regulations for in vitro diagnostics for TB. Dr. William Burman of the Denver Public Health Department discussed “Current Tuberculosis Diagnostics: The Role of Diagnostic Tests for Latent and Active Tuberculosis.” RADM. Kenneth Castro, USPHS, CDC, presented the “Public Health Implications for Reclassification.” After the presentations, an open public hearing was conducted in which five statements were made by members of industry, the Association of Public Health Laboratories, the American Society of Microbiology, and a trade advocacy group.

The FDA presented the Panel with the question, What is the appropriate classification of 1) NAAT tests for the detection of M. tuberculosis complex directly from patient specimens, 2) indirect tests of tuberculosis infection, and 3) tests for the rapid detection of M. tuberculosis complex resistance mutations by nucleic-acid amplification directly from patient specimens? After discussion and careful deliberation, the Panel recommended reclassification from class III to class II for each of the three categories of diagnostic tests.

If the FDA acts on the recommendations of the Panel, FDA will publish a notice of the Panel’s recommendation and propose a new regulation in a docket for public comment. Following public review and comments, FDA may then publish a Federal Register Notice to propose reclassification with Special Controls Guidance (referred to as the proposed rule). FDA will receive and review comments to the proposed rule and render a final decision. If and when reclassification occurs, final actions will be published as a Federal Register Notice, and FDA will publish the related Special Controls Guidance. DTBE encourages state and local health departments and relevant sectors in academia to follow this issue and exercise their role in making public comment.

Complete FDA meeting materials of the microbiology devices panel

—Submitted by Michael Iademarco, Chief, Laboratory Branch
Div of TB Elimination


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