A Diagnostics & Imaging Week

A large, and largely untapped, market exists for more effective and more affordable tests to diagnose tuberculosis in low- and middle-income countries where most TB cases occur, according to a new report by the Special Programme for Tropical Disease Research and Training (WHO/TDR) and the Foundation for Innovative New Diagnostics (FIND; both Geneva).

The report, titled "Diagnostics for Tuberculosis: Global Demand and Market Potential," says that most people in the world who have TB, or live in TB-risk areas, have little access to rapid and accurate testing. The report estimates that one-third of the world's population is infected with latent TB, and at risk of developing the active disease.

HIV also is fueling TB epidemics in many countries, and multi-drug resistance is a growing threat. Roughly 1.7 million people a year die from TB, many because the infection goes undiagnosed or diagnosed too late to be cured.

"The TB and HIV threat continues to grow in many parts of the world, and governments need high-quality diagnostics to help manage these epidemics," said Dr. Robert Ridley, director of TDR. "We need simple tests to accurately screen for, and identify, active tuberculosis. New tests also are needed to monitor treatment response, to identify bacterial drug resistance and to detect latent infection in people at greatest risk for progression to active TB."

Only about 2.2 million TB cases annually are diagnosed and reported with sputum smear microscopy, the most widely available test, TDR says, and other cases are diagnosed through what it calls an "inefficient and sometimes wasteful combination of chest X-rays, bacterial cultures and guesswork."

The global market for TB diagnostics is estimated to be more than twice that for drugs used to treat the disease. Worldwide, about $1 billion is spent on TB tests and evaluations, which screen some 100 million people annually; around $300 million is spent on drugs for treatment.
High-tech molecular and rapid culture diagnostics available in developed countries are too complex and costly for many settings where TB is most prevalent, the report says. And sputum smear, X-ray and culture tests may fail to make distinctions between latent and active TB, and between drug sensitive and drug resistant forms of the disease.

Giorgio Roscigno, CEO of FIND, said, "We need to use this market analysis to encourage the development of accurate, affordable and easy-to-use diagnostics for developing countries."

The report, financed by the Bill and Melinda Gates Foundation, involved more than 100 public health and industry experts as well as several international agencies.

In middle- and low-income countries, more than 66 million sputum microscopy examinations, 39 million chest X-rays, and 8.5 million cultures are performed each year on suspected TB patients - but using technologies developed 50-100 years ago.

Compared to vaccines and medicines, the cost of developing new diagnostics and adapting existing ones is relatively low – from $1 million to $10 million per technology platform, the report estimates. It projects demand for seven hypothetical products that could feasibly be developed within this scale.

WHO/TDR is a global program of scientific collaboration established in 1975, sponsored by WHO, World Bank, United Nations Development Programme and UN Children's Fund.

FEI imaging center opened

The University of Ulster earlier this month opened the FEI Centre for Advanced Imaging in Northern Ireland to provide a suite of electron microscopes made by FEI (Hillsboro, Oregon) for research within the university's Biomedical Sciences Research Institute. It also will support academic research from other faculties within the university and beyond, including industrial R&D for the university's industrial partners within the region.

The center is equipped with a suite of FEI tools, including a Quanta ESEM (environmental scanning electron microscope), a Tecnai cryo TEM (transmission electron microscope), and a Nova NanoLab, the world's first DualBeam (scanning electron microscope/focused ion beam) system to provide cryo applications. Advances incorporated in the Nova NanoLab were developed through collaboration between FEI and George McKerr of the university.

The center is funded in part by a 1.3 million pounds investment by the Department for Employment & Learning and the Office of Science & Innovation through the UK Science Research Investment Fund (SRIF).

Leading applications at the center will focus on addressing potential hazards related to nano-enabled technologies. According to Professor Vyvyan Howard, head of the university's Bioimaging Research Group.

"We intend to be recognized as one of the world centers of excellence for investigating nanoparticle toxicology," said Howard. "There will be a lot more work to do in the coming years because every single product that is developed containing free nanoparticles will have to undergo a toxicological safety assessment. With funding procured within the last few months the new Centre will have five highly qualified research scientists working full time in this area."

FEI provides instruments for nanoscale imaging, analysis and prototyping, with R&D centers in North America, Europe and India, and sales and service operations in more than 50 countries around the world.

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