Diagnostics for Tuberculosis: Global Demand and Market Potential

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World Health Organization, 2006 - Medical - 203 pages
In this report, the World Health Organization's Special Program for Tropical Diseases Research (TDR), in collaboration with the Foundation for Innovative New Diagnostics (FIND), has compiled existing epidemiological data and generated a wealth of new data on the availability of TB laboratory services, variations in physician diagnostic practices, workloads of national laboratory networks, and manufacturer's sales to authoritatively document the volume and market value of TB diagnostic testing in nearly 200 countries. Customer requirements and R& D opportunities are clarified and the major scientific, financial, and market entry challenges specific to TB diagnostic development are presented alongside short and long term strategies and solutions. Furthermore, the potential future TB diagnostic market is estimated for a range of hypothetical new diagnostic tests covering the three major testing indications. Fourteen countries are profiled in detail to complement the global perspective.

This report drafted with extensive input from experts in tuberculosis and public health, as well as from private industry, provides essential data and knowledge to dispel common myths and inform investment decisions by industry foundations, government organizations, and world health and financial organizations.

The report is comprised of seven chapters, fourteen country profiles, and an appendix addressing global in vitro diagnostic regulatory practices and classification schemes.
 

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Page 26 - Have halted by 2015 and begun to reverse the spread of HIV/AIDS TARGET 8 Have halted by 201 5 and begun to reverse the incidence of malaria and other major diseases...
Page 202 - III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
Page 26 - Communities), the International Monetary Fund (IMF), the Organisation for Economic Co-operation and Development (OECD), the Statistical Division (UNSTAT) and regional commissions of the United Nations Secretariat, and the World Bank.
Page 202 - A device undergoing consumer preference testing, testing of a modification, or testing of a combination of two or more devices in commercial distribution...
Page 189 - CDC (Centers for Disease Control and Prevention). Reported tuberculosis in the United States, 1993, October, 1994, pp.
Page 189 - American Thoracic Society. Diagnostic standards and classification of tuberculosis in adults and children. Am J Respir Care Med.
Page 198 - ... derived from the human body, to provide information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.
Page 201 - ... Medical Devices are those for which safety and effectiveness can be ensured through routine administration;. Class II Medical Devices are those for which further control is required to ensure their safety and effectiveness. Class III Medical Devices are those which are implanted into the human body...
Page 186 - ... and pinocytosis. ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA): An assay in which an enzyme is linked to an antibody and a labeled substance is used to measure the activity of bound enzyme and.
Page 9 - I hope that this report by the Special Programme for Research and Training in Tropical Diseases (TDR...

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