NTM Culture, Biorepository and Coordinating Core
Within the CF microbiome, NTM are a distinct group of organisms, with over 170 different species and subspecies that vary markedly in pathogenicity. Progress in clinical research has been slow, as NTM infection is not a reportable disease and requires highly specialized culture techniques. A fundamental obstacle for both clinicians and researchers is the lack of access to state-of-the-art laboratory support to culture and identify organisms using molecular tools. NJH is the home to the largest mycobacteria treatment program in the United States, and offers the world-class facilities for mycobacterial culture, drug pharmacokinetic, and molecular diagnostics that are needed to systematically study NTM infections in the context of CF. While currently many physicians nationwide send NTM isolates or raw sputum samples to NJH for identification or expanded drug-susceptibility testing (DST), there is no mechanism in place to identify which samples originate from CF patients, or to integrate these results within the context of the Care Center Network. Following a model successfully developed by Dr. John LiPuma at the University of Michigan within the CFF-supported B. cepacia Research Laboratory and Repository, isolates submitted from within the CF Care Center Network will be tracked and undergo additional analysis. In addition to identification and DST, strains within the same subspecies will be forwarded to the Molecular Core (described below) for genetic fingerprinting, for the purpose of monitoring of clonal strains within Centers and between Centers. If detected, the Core will inform the Care Centers of the potential that transmission is occurring. In addition, these isolates will be banked for future analysis, as the methods available for analysis of clonality is evolving rapidly. Dr. LiPuma has advised in the development of this RDP, and is serving on the External Advisory Committee.
Therefore, we propose to establish an NTM Culture, Biorepository, and Coordinating Core under the direction of Charles Daley and Max Salfinger, to support the clinical care of CF patients within the CFF Care Center Network, as well as translational research and clinical trials. This Core will work in a synchronized fashion with the Molecular and Clinical Research Cores proposed in this application, as well as the Pilot Project.
The central mission of the NTM Culture, Biorepository, and Coordinating Core are to provide:
Essential state-of-the-art culture
Drug susceptibility testing (when requested),
Banking of isolates and distribution to qualified investigators
Coordination of data and communication of results to CF Centers.
Specific aims are contained within the core proposal.