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Department of Health and Human Services
Food and Drug Administration
Microbiology Devices Panel
Reclassification of Molecular Diagnostics for the Rapid Detection of Mycobacterium tuberculosis complex [Docket No. FDA-2011-N-0002]
To Whom It May Concern:
The American Society for Microbiology (ASM) appreciates the opportunity to provide written comments to the FDA Microbiology Devices Panel of the Medical Devices Advisory Committee regarding the reclassification of molecular diagnostics for the rapid detection of Mycobacterium tuberculosis. The ASM is the largest educational, professional and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents more than 38,000 microbiologists professionally employed in a variety of areas, including biomedical, agriculture and environmental microbiology, as well as public health and clinical microbiology and immunology.
The ASM strongly supports the reclassification of molecular diagnostic devices for the detection of M. tuberculosis (MTB) from PMA approval to 510(K) clearance. Support for the reclassification is based on:
ASM recommends that the FDA consider 510(K) submission for all new molecular MTB assays intended for the purpose of detecting MTB from smear-positive and smear-negative respiratory specimens. We propose that the following minimal requirements for assay performance be considered for this mode of submission:
It should be emphasized that performance characteristics (as outlined above) should not be the only consideration for a molecular diagnostic device for MTB detection. The ASM supports the 510(K) submission pathway for devices that are:
These attributes allow laboratories without significant molecular expertise the opportunity to perform rapid molecular diagnostic tests for MTB. In addition, many larger laboratories in the United States continue to send MTB molecular testing to a reference lab due to the costs associated with batch testing small numbers of samples. Allowing laboratories of all sizes and expertise access to MTB molecular testing is critical to decrease the time to result of MTB detection from direct respiratory specimens.
Although the need to quickly determine rifampin resistance is of critical clinical and public health importance, at this time the ASM does not support the reclassification of a molecular rifampin resistance detection device. A significant amount of clinical data will need to be obtained to determine the positive and negative predictive values in areas of low prevalence in the U.S. We realize there is a pre-existing FDA cleared closed platform multiplex assay that detects both the organism and a resistance marker (Cepheid SA Nasal Complete, Cepheid MRSA/SA SSTI), but we assert that the risk to the patient and public health is much greater with the misdiagnosis of MDR-TB.
In summary, the ASM is fully supportive of reclassifying molecular diagnostic devices aimed at the detection of MTB from primary respiratory samples to 510(K) clearance. Increased access to FDA cleared rapid, molecular diagnostic devices for MTB has the potential to greatly impact patient care and reduce transmission potential throughout the United States.
Thank you for the opportunity to comment.