A Medical Device Daily

A large, and largely untapped, market exists for more effective and more affordable tests to diagnose tuberculosis (TB) 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).

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 — 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.

The Special Programme for Research and Training in Tropical Diseases (TDR) is a global program of scientific collaboration established in 1975, sponsored by the World Health Organization, World Bank, United Nations Development Programme and UN Children's Fund; it is based in Geneva, Switzerland. Its focus is research into neglected diseases of the poor, with the goal of improving existing approaches and developing new ways to prevent, diagnose, treat and control these diseases.

Medical Services opens test division

Medical Services International (Edmonton, Alberta) reported opening a new division for the regulatory testing and clinical trials of new products. The company has plants in India, New Jersey, Nigeria, China and the Caribbean to offer services related to testing of products and clinical trials to companies who do not have the staff or facilities to complete them or companies requiring independent testing.

Medical Services said it anticipates participating in at least two sets of testing in the next year, generating in excess of $4 million in revenue.

It said it continues to expand its VScan operation by increasing its distributors and regulatory approvals in additional countries.

The VScan rapid test kit is a single use test for HIV 1&2, Hepatitis B&C, tuberculosis, fever, West Nile, malaria, and prostate cancer.

SCRUM to be MDS Sciex distributor

MDS Sciex (Toronto) and SCRUM , a life sciences technology distribution company in Japan, reported an agreement for SCRUM to distribute MDS Sciex's CellKey system in Japan.

CellKey technology enables the use of endogenous cell receptors — expressed in their natural state — to test new compounds, instead of using cells that have been genetically manipulated. The system does not require the luminescent or fluorescent tags that can adversely affect the response of cells to new compounds. As a result, it can produce drug screening results with greater biorelevance.

The system's underlying technology is Cellular Dielectric Spectroscopy, an impedance based measurement system that eliminates the need for tags, dyes or specialized reagents.

"Japan represents one of the fastest growing markets in drug discovery," said Andy Boorn, president of MDS Sciex. "SCRUM is a well-respected life sciences company capable of providing extensive sales and support coverage throughout Japan."

MDS Sciex is the scientific instrumentation and technology solutions division of MDS (Toronto).

MetriGenix now Xceed Molecular

MetriGenix (Toronto), a developer of gene-expression analysis systems, has changed its name to Xceed Molecular, denoting the company's transitions from development stage to a "customer-focused business," it said, "with innovative products and services designed to translate biomarker-based tests from research into routine clinical use."

Michael Cohen, Xceed CEO, said, "Our goal is to improve health outcomes by accelerating multiplex tests from research to clinical use. To succeed, we are making routine multiplex tests feasible, fast and affordable."

Xceed has developed Flow-Thru Chip technology, a microporous silicon substrate for biological analysis enabling hybridizations four-times faster than conventional microarray formats, according to the company.

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