A new, independent, nonprofit initiative to create cheap and simple diagnostics for tuberculosis (TB)—and eventually other diseases—in collaboration with academia and industry was launched last month by the Special Programme for Research and Training in Tropical Diseases (TDR) and by the Bill and Melinda Gates Foundation, which has donated $30 million for the first 5 years of the project.

The Foundation for Innovative New Diagnostics (FIND) will seek to replace the cumbersome sputum test for TB with faster, more practical tests. The sputum test is impractical for rural settings in the developing world, as it requires both microscopy and electric power to refrigerate and shake reagents.

FIND will be directed by Giorgio Roscigno, the founding director of the Global Alliance for TB Drug Development. Carlos Morel, TDR's director, told The Scientist that he was "delighted" by the creation of FIND, which followed the same route, he said, as the creation from TDR initiatives of the Medicines for Malaria Venture (MMV) and other bodies and helped keep TDR "efficient."

But some sources close to TDR, although they were not prepared to be quoted, were not so sanguine, fearing an increasing loss of TDR's best work—and funding—in the creation of independent ventures.

In fact, in 2001 the Gates Foundation gave a 5-year, $10 million grant to establish a TB Diagnostics Initiative (TDI) at TDR, and there had been hopes that this would be expanded within the program. Now TDI has effectively been hived off and expanded outside TDR to make FIND, and Mark Perkins, who directed TDI, will become its scientific director.

The independence might suit FIND, although most of the advantages claimed at the Geneva launch on May 22—such as easy interaction with industry—are also advantages justifiably claimed by TDR itself in its own promotional material.

TDR is co-sponsored by the United Nations Development Programme (UNDP), the World Bank, and the World Health Organization (WHO). The problem, according to The Scientist's sources, is that the Gates Foundation requires complete independence in the scientific and administrative control of its projects and fears political interference in any institution with governmental partners. At TDR this partnership comes through the annual meeting of the program's Joint Coordinating Board, which includes representation from the main donor governments as well as the UN governmental organizations like WHO and UNDP. Although a major donor, the Gates Foundation does not have a place on the board. Moreover, the bureaucracy of WHO, through which all TDR contracts are reviewed, is also seen as a brake and constraint.

TDR has also been getting closer to practical, field-level issues in tropical diseases—such as the home-based management of malaria, which it has shown can reduce child mortality by half—and basic scientists have complained that its budgets have been shrinking and that it has become too directive. This is thought to have formed part of the motivation for the scientific management structure of the Gates Foundation's own Grand Challenges in Global Health research initiative, announced this January, to be run by the NIH rather than by bodies like TDR.

But the Gates Foundation has been unable to provide The Scientist with a spokesperson to discuss these points and responded to queries only by e-mail. Peter Small, senior program officer at the Foundation, wrote "As an independent organization, FIND will have the flexibility it needs to work effectively with both private companies and public health institutions. By bringing together a broad range of partners, FIND has the potential to significantly accelerate the development of diagnostics for the world's most deadly diseases. Its work will be carried out in close coordination with TDR, whose expertise and international influence will be invaluable to this effort."

With regard to the aims of FIND, Perkins explained the key to FIND's practical work would be to work with industry and create "appropriate" and fully field-tested technologies (a necessary objective, as in most developing countries diagnostics are unregulated).

FIND will work to ensure that products it helps develop are appropriately priced for the developing world, but this may not always require huge concessions from commercial test developers. "As 95% of the tuberculosis disease burden rests in the developing world, many companies working on TB tests are already targeting high volume but low profit markets," Perkins told The Scientist. "If there are 150 million people a year in developing countries with symptoms suggestive of tuberculosis, even a low cost test may produce significant revenues. Companies see this, and pushing for quality may often be more critical for us than pushing for price control."

"Diagnostics development is rapid compared to drugs or vaccines, and already there are five or six 'real technologies' that companies are turning into diagnostic products," said Perkins.

"A number of new TB diagnostic tests have arrived on the market in the past three years, but some of them are essentially 'phantom' tests, in that little is known about their real performance," said Perkins. "One of the first orders of business in TDR has been to discover whether any of those new tests meet our needs."

It was clear from TDR's first survey of the field in TDI that there were no silver bullets that would meet everyone's needs, Perkins said. "As in all technology development efforts, there are compromises, especially in the early phase, and finding the right clinical situation to use a given technology may take as much time and energy as developing the technology itself."

Beyond technology evaluation, increased support for research and development is needed. "Without additional support, many test development groups just can't afford to take on high-risk projects or to dig into yet-untested technologies. The detection of bacterial antigens or small molecules in clinical specimens, for example, is an area that deserves much more emphasis, but isn't getting it from industry. We need to bring in outside funds to keep the development pipeline full of promising technologies. Otherwise we will still be working with the same half-dozen technologies 5 years from now."