RAPID SCREENING METHOD FOR MULTIDRUG RESISTANT TB

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Tuberculosis remains the leading cause of death in the world from a single infectious disease. In particular, the spread of multi-drug resistant tuberculosis (MDR-TB) is becoming a critical issue in many countries. One of the main causes of this is the lack of an efficient and rapid method for diagnosis and screening of various strains of M. tuberculosis. Existing methods are time consuming and require long incubation periods for accurate results. It is the purpose of this project to develop a new instrument to exploit recent breakthroughs in biochemical tagging of the tuberculosis bacteria to result in a new standard for rapid screening of large patient populations. The extensive experience of InterScience in intensified digital imaging will be combined with the significant capabilities of the Albert Einstein College of Medicine (AECOM) to yield a method for rapidly determining the drug susceptibility patterns of M. tuberculosis. This new approach is based on the breakthrough methods developed at AECOM to produce and use luciferase reporter mycobacteriophages (LRM) to generate photons that indicate the state of metabolic well being of a mycobacteria cell. This photon generation signals the drug susceptibility of the samples. By coupling this method with an ultra-sensitive, digital imaging system to be developed by InterScience, a state of the art tool results which can provide rapid, quantitative data on the drug susceptibility patterns. This data, being digital in nature, can be archived, analyzed and transmitted via uplink which allows the instrument to be used in remote sites. Phase I will result in a prototype version of the system tested with the LRM protocol to pave the way for full development of a compact, field ready version in Phase II. This will be a concrete demonstration for commercial development for a worldwide market. PROPOSED COMMERCIAL APPLICATIONS: The development of a compact system for rapid diagnosis and drug susceptibility patterns of TB will have an immediate impact on the commercial market. It is envisioned that the advanced detector system will be used for rapid screening in both developed and developing nations. The digital nature of the instrument will allow for a link between remote locations and central health centers for quantitative analysis and archiving. Once feasibility is demonstrated, commercial partners will be identified for rapid, large scale production.