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Phase 5 (2012 Deadline)
Development and Commercialization of a Blood Based Tuberculosis Diagnostic Test Imran H. Khan, University of California, Davis: Natasha Anwar, Forman Christian College Project Overview Pakistan is ranked sixth in Tuberculosis (TB) prevalance among 22 high burden countries. For effective treatment it is critical to detect Mycobacterium Tuberculosis (M.tb) as soon as possible. Improved methods for detecting M.tb infection will enable physicians to provide effective treatment sooner. The project’s goal is to develop a blood based multiplex microbead test for screening TB. This test is to be sensitive, specific, reliable, and cost-effective.
Progress Reports 2014 Summary Report
Tuberculosis is a curable disease provided appropriate drug therapy is administrated in a timely and appropriate manner. Pakistan is ranked 6th in the TB prevalence among 22 high burden countries. Over the last decade there has been substantial increase in drug resistance. Methods for accurate and cost effective diagnosis of infection with pathogenic Mycobacterium tuberculosis (M.tb). It is critical to detect M.tb infection in TB suspects as early as possible for effective treatment. Current methods have various limitations in terms of sensitivity, accuracy and cost effectiveness. This project was aimed to build healthcare capacity in Pakistan by developing new blood based multiplex microbead diagnostic method for detecting active TB. This project on novel methods for TB diagnostics was designed to increase the capacity of science and technology to improve the wellbeing of the citizens of Pakistan and other TB endemic countries. Improved methods for detecting M.tb infection will enable physicians to initiate appropriate anti-TB therapy (DOTS) sooner.
Preliminary results of clinical validation study in Year 1 show that the prototype test developed in this project is more sensitive than the commonly used, WHO recommended procedure on microscopic determination of patient sputum. Such rapid and accurate TB testing methods will be important for healthcare workers as well as patients in clinics and hospitals. In addition, the collaborative activities and transfer of multiplex microbead immunoassay technology will improve the quality and capacity of infectious disease research at Pakistani institutions of higher education. This project may lead to establishing an intermediate level laboratory network consisting of one reference laboratory possibly in each district in coming years, and to expand the number of hospitals and rural health centers that serve as diagnostic centers. Hence, this technology has a potential to become practical for wide introduction in TB clinics in many regions of Pakistan and other TB endemic countries. Because of the ability to process numerous samples in high throughput fashion, this blood based test for active TB detection is cost effective, relative to other TB diagnostic modalities, in a setting where resources are limited.
2015 Summary Report
Results of clinical validation study in Year 1 and 2 show that the prototype test developed in this project is more sensitive than the commonly used, WHO recommended procedure on microscopic determination of patient sputum. Such rapid and accurate TB testing methods will be important for healthcare workers as well as patients in clinics and hospitals. In addition, the collaborative activities and transfer of multiplex microbead immunoassay technology will improve the quality and capacity of infectious disease research at Pakistani institutions of higher education. This project may lead to establishing an intermediate level laboratory network consisting of one reference laboratory possibly in each district in coming years, and to expand the number of hospitals and rural health centers that serve as diagnostic centers. Hence, this technology has a potential to become practical for wide introduction in TB clinics in many regions of Pakistan and other TB endemic countries. Because of the ability to process numerous samples in high throughput fashion, this blood based test for active TB detection is cost effective, relative to other TB diagnostic modalities, in a setting where resources are limited. The success in Pakistan has sparked an interest in commercialization of the TB blood test in Russia and India. A pilot project was launched last week at the National Institute for Research in Tuberculosis (NIRT), Chennai, India, to prepare for approval and commercial launch of the test in India.
2016 Summary Report
Tuberculosis is a curable disease provided appropriate drug therapy is administrated in a timely and appropriate manner. Pakistan is ranked 6th in the TB prevalence among 22 high burden countries. Over the last decade there has been substantial increase in drug resistance. Methods for accurate and cost effective diagnosis of infection with pathogenic Mycobacterium tuberculosis (M.tb). It is critical to detect M.tb infection in TB suspects as early as possible for effective treatment. Current methods have various limitations in terms of sensitivity, accuracy and cost effectiveness. This project was aimed to build healthcare capacity in Pakistan by developing new blood based multiplex microbead diagnostic method for detecting active TB. This project on novel methods for TB diagnostics was designed to increase the capacity of science and technology to improve the wellbeing of the citizens of Pakistan and other TB endemic countries. Improved methods for detecting M.tb infection will enable physicians to initiate appropriate anti-TB therapy (DOTS) sooner. Results of our studies demonstrate that the prototype test developed in this project is more sensitive than the commonly used, WHO recommended procedure on microscopic determination of patient sputum. Such rapid and accurate TB testing methods will be important for healthcare workers as well as patients in clinics and hospitals. In addition, the collaborative activities and transfer of multiplex microbead immunoassay technology will improve the quality and capacity of infectious disease research at Pakistani institutions of higher education. This project may lead to establishing an intermediate level laboratory network consisting of one reference laboratory possibly in each district in coming years, and to expand the number of hospitals and rural health centers that serve as diagnostic centers. Hence, this technology has a potential to become practical for wide introduction in TB clinics in many regions of Pakistan and other TB endemic countries. Because of the ability to process numerous samples in high throughput fashion, this blood based test for active TB detection is cost effective, relative to other TB diagnostic modalities, in a setting where resources are limited. The success in Pakistan has sparked an interest in commercialization of the TB blood test in Russia and India. Studies in collaboration with these countries are now ongoing.
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