Showing posts with label FIND. Show all posts
Showing posts with label FIND. Show all posts

Saturday, 2 July 2011

TUBERCULOSIS: Progress on MDR-TB, but not enough

JOHANNESBURG, 24 March 2011 (PlusNews)

 Photo: Gary Hampton/World Lung Foundation
MDR-TB is resistant to first-line TB drugs

Gains have been made in stopping multidrug-resistant tuberculosis (MDR-TB), a largely undiagnosed killer, but not enough. By 2015 there will be two million new cases, says a new report by the World Health Organization (WHO).
MDR-TB is resistant to first-line TB drugs, such as isoniazid and rifampicin, while extensively drug-resistant TB (XDR-TB) is resistant to these drugs as well as at least half of the mostly commonly used second-line drugs.
In 2008, the latest year for which estimates are available, WHO put the number of MDR-TB cases at 440,000 globally, with 34 percent resulting in death.
In its new progress report, the organization charted gains made in the fight against drug-resistant TB, including increases in second-line drug availability, diagnostic capability, and national TB drug-resistance data.
Dr Ernesto Jaramillo, the WHO medical officer in charge of MDR-TB policy and author of the report, said the world was far from being on track to meet the 2015 deadline for universal access to diagnosis and treatment of resistant patients.
He stressed that MDR-TB was a complex issue, and cited a lack of funding, capacity and adequate staff in the 27 countries with a high MDR-TB burden.
WHO noted in its 127-page report that the Global Drug Facility, a WHO procurement mechanism, had improved access to drugs, and although the number of pharmaceutical companies supplying these drugs had tripled since 2008, it remains small.
National laboratory capabilities have also improved and all high- burdened countries can now conduct drug susceptibility tests to confirm MDR-TB at their larger reference laboratories, but point-of-care diagnostics are still scarce. WHO expects that by 2012, all high-burdened countries will have representative data on TB drug resistance to help guide their response.
In 2010, the Foundation for Innovative New Diagnostics (FIND) released the Xpert MTB/RIF TB point-of-care test, which detects TB and rifampicin resistance within two hours. The test is much more accurate than those previously available at district-level health centres, but at US$17,000 per unit the machine may prove too costly for widespread use in developing countries.
The report called for more funding for research into devices like this as well new treatments and vaccines. It also noted that a lack of such diagnostic tools may be partly why only about 10 percent of MDR-TB patients in high-burden countries are diagnosed, and only about 11 percent globally receive treatment.
DOTS - Directly Observed Treatment, in which patients are individually observed and supported to take TB medication daily - remains the cornerstone of TB and MDR-TB control, but Jaramillo said implementation was often hampered by poor health systems, which might mistakenly be using old TB thinking to treat a new drug-resistance threat.
“It’s like dealing with a new disease,” he told IRIN/PlusNews. “The only thing [MDR-TB] has in common with the old TB is the letters ‘T’ and ‘B’ - the drugs are new, the ways of monitoring patients are new, and the patients are more difficult to treat.”

Show me the money
Although countries have increased domestic funding for MDR-TB programmes, WHO and the Global Fund to Fight AIDS, TB and Malaria have warned that current allocations will be inadequate. WHO said an estimated $1 billion would be needed to fund the fight against MDR-TB by 2015 - about half current budget.
Contributions to the 2010 Global Fund replenishment fell short by an estimated $2billion, but it will still fund about 18 percent of the costs to control MDR-TB in 2011.
Some countries, like South Africa, the Russian Federation and Latvia, are likely to fund almost all of their MDR-TB response domestically, but the Fund may become the sole provider of second-line drugs and MDR-TB management in at least seven other high-burden countries.
“MDR-TB is a threat to all countries, as it is difficult and expensive to treat,” said Michel Kazatchkine, executive director of the Global Fund in a statement. “Unless we make an extraordinary effort to tackle this problem, our ability to finance and secure continued progress against TB in general will be threatened.”
Jaramillo noted that national economic decisions were often political ones, and urged civil society to keep the spotlight on TB as a top political priority in the worst affected countries.
http://www.plusnews.org/IndepthMain.aspx?InDepthID=90&ReportID=92273

Thursday, 30 June 2011

MALARIA: Staying the course on malaria research

JOHANNESBURG, 28 June 2011 (IRIN)

 Photo: Wendy Stone/IRIN
Lack of testing leads to frequent misdiagnosis in Africa

 Funding for malaria research and development has quadrupled in the past 16 years - new drugs, diagnostics and insecticides have been developed and a vaccine is in the final stage of testing - but the constantly adapting malaria parasite means the pipeline of new products and technologies needs to keep flowing.
A new report, "Staying the Course? Malaria Research and Development in a Time of Economic Uncertainty", analyses the progress that unprecedented levels of funding has achieved in recent years and warns that the future of the global fight against malaria depends on better coordination among a larger number of donors and ensuring that the money is more evenly spread.
Currently, the lion's share of research and development (R&D) funds goes to developing new drugs (38 percent), vaccines (28 percent) and basic research (23 percent), while research into diagnostic tests receives a paltry 1 percent of funding, and product development for controlling malaria-carrying mosquitoes (vector control) just 4 percent.
Partly this is because developing and testing new drugs and vaccines is much more costly than developing diagnostics and vector control products, but David Bell, head of the malaria diagnostics programme at the non-profit Foundation for Innovative New Diagnostics (FIND), believes it also reflects donor preferences.
"It's easy to sell the idea of a drug or vaccine because it saves lives. A diagnostic test also saves lives by stopping a child being given the wrong drug and ensuring they receive the right drug... but it's harder to sell that to donors," he told IRIN on the phone from Geneva.
Bell described his field as "grossly underfunded". This has slowed the development of new diagnostic tools and made it difficult to ensure the quality of existing tests for detecting malaria - in sub-Saharan Africa, where the use of diagnostic tests is not widespread, patients presenting with a fever are often misdiagnosed with malaria and treated for the wrong disease.
The report, published by the global health non-profit, PATH, and the Roll Back Malaria Partnership, estimates that funding for diagnostic tests needs to quadruple and remain at US$50 million per year for the next four years.
Some of the most pressing needs are for the development of rapid tests for less common types of malaria; a way to screen pregnant women with low levels of malaria parasites that can still harm a foetus; and more sensitive tools for detecting a potential resurgence of the disease in areas with low prevalence.
"The problem in areas where mortality [from malaria] is very low because interventions have worked, is that people lose interest and there's a danger we'll see a rebound in malaria, so we need to have these new tools to manage that," said Bell.

Vector control neglected
Spraying insecticides and treated bed nets have yielded impressive results in reducing the malaria burden in many parts of the world, but vector control has been neglected in recent years - just when resistance to the one class of insecticides licensed for use with bed nets, pyrethroids, has become widespread.
"There are very few locations [in Africa] where there isn't [pyrethroid] resistance," said Janet Hemmingway, CEO of the non-profit research group, Innovative Vector Control Consortium (IVCC). "If resistance is sufficiently strong, a treated bed net is of no more use than an untreated one."
Developing a new active ingredient is a seven-year process because of the need for long-term toxicology reports, but IVCC is looking at several agricultural insecticides to determine whether they could be "re-purposed" for malaria control.
"We know there's nothing ideal, but there could be something that would hold the fort for a few years while we get some new active [ingredients] through [the process]," said Hemmingway.
IVCC is also developing a simple point-of-use test to determine whether a net has been treated properly, and another for monitoring insecticide resistance in mosquitoes - but even with a five-year, $50 million grant from the Bill & Melinda Gates Foundation, and a further $28 million from other donors, they still face a $100 million funding shortfall.

More donors needed
Total funding for malaria R&D reached $612 million by 2009, up from $121 million in 1993, but nearly three-quarters of that amount was provided by nine organizations, most of them public and philanthropic, and just two organizations - the Gates Foundation and the US National Institutes of Health (NIH) - accounted for half of all funding, and most of the increase in funding in recent years.
According to the report, funding for malaria R&D only needs to increase by 2 percent per year to meet the goals agreed by the international malaria community in the 2008 Global Malaria Action Plan (GMAP). After 2016, earlier investments should start paying off and funders can begin to scale back their contributions. However, this best-case scenario depends on donors coordinating with each other to ensure funds are distributed more evenly.
The Roll Back Malaria Partnership hopes to achieve this during two donor meetings later in 2011. "We need to ensure the main donors are aware of the poor distribution of funds," said executive director Awa Marie Coll-Seck.
"We're hoping new donors will come along - it's important to diversify," she said, insisting that the goal of eradicating malaria from the world, set out in the GMAP, was still within reach.
"All the elements are in the pipeline - a vaccine, insecticides, diagnostics. The more results we see, the more we think it is possible," Coll-Seck told IRIN. "But the malaria parasite is always changing and adapting; you need to always be developing new tools to stay ahead of it."
http://www.irinnews.org/report.aspx?reportID=93090

Monday, 28 March 2011

TUBERCULOSIS: What's new in TB technology?



 Photo: Gary Hampton/World Lung Foundation
Innovative TB technology

JOHANNESBURG, 28 March 2011 (PlusNews) - In keeping with the focus on innovation as part of World Tuberculosis (TB) Day in March 2011, IRIN/PlusNews brings you a wrap of some of recent developments in TB technology.

1. GeneXpert: The two-hour TB test released in 2010 is a joint project by Cepheid, a diagnostic products manufacturer, the Foundation for Innovative New Diagnostics (FIND), a non-profit organization, and the University of Medicine and Dentistry of New Jersey, in the US.
The desktop computer-based system, approved by the World Health Organization, shaves three weeks off the usual waiting time for diagnoses and can test for TB and drug-resistant TB. Tests cost about US$20 each and are said to be more accurate than previous tests. The system was recently introduced in South Africa.

2. One-hour rapid test: The United Kingdom's Health Protection Agency (HPA) reported it had developed the test shortly after GeneXpert was announced. The one-hour test focuses on detecting a single DNA molecule in TB and expected to be more sensitive than most other rapid tests that look for a sequence of DNA, which may not be present in newer TB strains of TB.
HPA spokesperson Georgina Fletcher said the test did not yet have a name. Clinical trials are to start in the United Kingdom this year and it was too early to say what the cost per test would be.

3. TMC207: The only drug on our list represented a breakthrough in the treatment of TB as well as multidrug-resistant TB when successful trial results were published in the New England Journal of Medicine in the US in 2009. The as yet experimental drug does not need to be refrigerated, potential dosing could be as low as three times a week, and there are only mild side effects. Tibotec, the manufacturers of TMC207, started working with national regulatory authorities in March 2011 to determine the requirements for approval. Tibotec indicated that it might be able to provide some countries, such as South Africa, with accelerated access to the drug.

4. Signature Mapping TBDx: Created by the Aurum Institute, a South African health NGO, imaging specialists Guardian Technologies International, and South Africa's national health laboratory services, the TBDx diagnostic system takes digital pictures of sputum samples and searches them for TB's structural "fingerprint."
In much the same way that airport x-ray machines detect bombs, TBDx uses digital microscopes to detect TB microbes by their shape. After positive results from initial testing in the national health laboratory services, the system is now in the final stages of an independently controlled clinical study in South Africa. Results are expected in April 2011 and tests are expected to cost around $5 each.

5. The 30-minute, "bacteria counter" test: Researchers at Massachusetts General Hospital in Boston and Harvard University, both in the US, developed a half-kilogram hand-held device in 2009 that counts even low levels of TB in sputum samples, using small, iron particles and radio waves. The test is said to be as sensitive as those using TB cultures, which can take weeks to grow in a lab.
At the time of publication, IRIN/PlusNews had received no response to requests for information on whether or not the test had been evaluated in large-scale trials.

6. Computer-aided diagnostics: The Zambia AIDS Related Tuberculosis (ZAMBART) project has partnered with Delft Diagnostic Systems and University of Cape Town Lung Institute to install an easy-to-use digital chest x-ray machine in one of the busiest clinics in Lusaka, the Zambian capital.
Student radiologists take the x-rays, which are stored in an electronic database until a clinical officer can read them. The images in the database are being used to develop a computer-aided diagnostic programme that in the future could help diagnose TB without the help of a trained radiologist.
http://www.plusnews.org/report.aspx?reportID=92301

Wednesday, 8 December 2010

TUBERCULOSIS: WHO endorsed NAAT rapid test for tuberculosis

The World Health Organization (WHO) today endorsed a new and novel rapid test for tuberculosis (TB), especially relevant in countries most affected by the disease. The test could revolutionize TB care and control by providing an accurate diagnosis for many patients in about 100 minutes, compared to current tests that can take up to three months to have results.
"This new test represents a major milestone for global TB diagnosis and care. It also represents new hope for the millions of people who are at the highest risk of TB and drug-resistant disease." said Dr Mario Raviglione, Director of WHO's Stop TB Department. "We have the scientific evidence, we have defined the policy, and now we aim to support implementation for impact in countries."
WHO's endorsement of the rapid test, which is a fully automated NAAT (nucleic acid amplification test) follows 18 months of rigorous assessment of its field effectiveness in the early diagnosis of TB, as well as multidrug-resistant TB (MDR-TB) and TB complicated by HIV infection, which are more difficult to diagnose.
Evidence to date indicates that implementation of this test could result in a three-fold increase in the diagnosis of patients with drug-resistant TB and a doubling in the number of HIV-associated TB cases diagnosed in areas with high rates of TB and HIV.
Many countries still rely principally on sputum smear microscopy, a diagnostic method that was developed over a century ago. But this new 'while you wait' test incorporates modern DNA technology that can be used outside of conventional laboratories. It also benefits from being fully automated and therefore easy and safe to use.
WHO is now calling for the fully automated NAAT to be rolled out under clearly defined conditions and as part of national plans for TB and MDR-TB care and control. Policy and operational guidance are also being issued based on findings from a series of expert reviews and a global consultation held last week in Geneva. The consultation was attended by more than a hundred representatives from national programmes, development aid agencies and international partners.
Affordability has been a key concern in the assessment process. Co-developer FIND (the Foundation for Innovative and New Diagnostics) is announcing today it has negotiated with the manufacturer, Cepheid, a 75% reduction in the price for countries most affected by TB, compared to the current market price. Preferential pricing will be granted to 116 low- and middle- income countries where TB is endemic, with additional reduction in price once there is significant volume of demand.
"There has been a strong commitment to remove any obstacles, including financial barriers, that could prevent the successful roll-out of this new technology," said Dr Giorgio Roscigno, FIND's Chief Executive Officer. "For the first time in TB control, we are enabling access to state-of-the-art technology simultaneously in low, middle and high income countries. The technology also allows testing of other diseases, which should further increase efficiency.”
WHO is also releasing recommendations and guidance for countries to incorporate this test in their programs. This includes testing protocols (or algorithms) to optimize the use and benefits of the new technology in those persons where it is needed most.
Though there have been major improvements in TB care and control, tuberculosis killed an estimated 1.7 million people in 2009 and 9.4 million people developed active TB last year.
http://www.stoptb.org/

Tuesday, 7 September 2010

TUBERCULOSIS: A new molecular test for tuberculosis made by Cepheid

By Kate Kelland
Sep 1, 2010 5:02pm EDT
A new molecular test for tuberculosis made by Cepheid can diagnose TB and detect a drug-resistant form of it far more easily and rapidly than other tests currently available, scientists said on Wednesday.
In a study in the New England Journal of Medicine (NEJM), researchers said that when used on 1,730 patients with suspected TB and suspected drug-resistant TB, the Xpert MTB/RIF test successfully identified 98 percent of all cases.
It also identified 98 percent of patients with a form of TB resistant to rifampin, or rifampicin -- one of the most powerful TB drugs -- and achieved these results in less than two hours.
Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases described the test findings as "impressive" in terms of speed, accuracy and sensitivity.
"Within two hours, you can not only have a diagnosis, but you can also have a good idea of the range of drugs you can use," he told Reuters, adding that such capabilities were "unheard of" with current testing methods.
Doctors say current diagnostic testing for TB -- which involves microscopy in labs with trained experts and can take weeks -- has barely been improved in the last 125 years.
Tests for drug-resistant TB can take months and are notoriously insensitive, so new, more accurate tools to rapidly diagnose TB and its drug-resistant forms are urgently needed.
"We're very pleased with the outcome," said Mark Perkins, chief scientific officer at the Geneva-based non-profit organization the Foundation for Innovative New Diagnostics (FIND), which worked on the study.
TB afflicts mostly the poor in developing regions such as sub-Saharan Africa, India and China, but also occurs in poor regions of developed nations and is common in patients with the HIV virus that causes AIDS. It is among the world's top 10 leading causes of death and killed 1.8 million people worldwide in 2008, or one person every 20 seconds.
COSTS
Perkins said his team had since followed up on this initial study and carried out further "demonstration trials" in six countries to see how the test works in real-life settings.
He said initial signs from these trials, which involved nearly 7,000 patients but have yet to be published or peer-reviewed, suggest the test is just as effective at detecting TB in real patients on the ground.
In a commentary about the NEJM study, Peter Small, who runs the TB program at the Bill & Melinda Gates Foundation global aid group, said he was encouraged by the results but concerned that the potential high cost of such a sophisticated test might limit its use around the world.
"Critical to a rapid scale-up of the test will be...whether its use improves outcomes for patients in a cost-effective manner," he wrote.
Perkins said FIND had already negotiated concessionary prices with Cepheid which would apply in developing countries which decide they want to use the test.
The machine and computer to analyze the tests cost around $17,500, and the negotiated price of the test kits for poorer countries will be based on the cost of manufacture plus a small margin, he said. He was not able to give a precise figure.
"Our goal is to make...tests as inexpensive as possible, This one happens to be quite sophisticated and quite difficult to make inexpensive. But it is like any other public good -- it will obviously have a big impact, and it obviously costs money."

http://www.reuters.com/article/idUSTRE68071A20100901