Medical Device Daily Washington Editor

WASHINGTON — One of the sessions held at this year's annual meeting of the American Association of Clinical Chemistry (AACC; Washington), had more the feel of the symposium of old, with considerable audience participation.

The session, titled "Diagnostics for Disease Control in Developing Countries," was led by Mark Perkins, PhD, chief scientific officer with the Foundation for Innovative New Diagnostics (FIND; Geneva, Switzerland).

Perkins said FIND was launched by the World Health Organization (WHO; also Geneva) five years ago and "was established in order to run like a small company so it had the speed of a small company," giving it "the ability to make things happen." At its web site, FIND describes itself as "dedicated to the development of rapid, accurate and affordable diagnostic tests through public-private partnerships."

After the members of the small gathering introduced themselves and their reasons for attending, Perkins said he was surprised at all the interest in tuberculosis (TB) in the room. He said FIND is "supposed to look at how we support development of new assays, but also look at delivery of those assays."

Perkins said "there are a lot of assays" for malaria, but not as many for TB. He said there are currently roughly 50 companies making about 100 rapid assays for TB. "That's the good news, but they perform pretty variably," and the fact that their controls are not standardized creates a problem for clinics in the developing world.

"The end result is that countries and health workers in those countries are unsure of the results they're getting," Perkins said. Hence, health workers in developing nations who see negative test results in a patient who exhibits the usual symptoms of that disease find it "difficult not to treat unless they're sure of the test."

Perkins said the current emphasis at FIND is to get all the companies to agree to a single testing protocol. In one such effort, FIND has engaged industry in developing positive controls for malaria tests. "We're developing malaria antigens that you can dry down and are stable for two years," he said, noting that the objective is to create a lyophilized control that can be easily stored and readily reconstituted for testing.

But in the end, "the whole point is making sure that the healthcare provider can be sure of the test," Perkins remarked.

Toward that end, one entity or another — unless industry wants to handle the task — has to come up with standards for verifying an assay's accuracy. Perkins said WHO "has no regulatory aspirations, and neither do we," but "we want to make controls available."

One attendee said, "It's critical when you develop an assay that you have access to genuine clinical samples" that reflect "the biodiversity that's in the real world." The current base of controls tends to rely on a fairly limited set, he said, and "you'll have surprises," he said.

"It would be nice to facilitate a collection of strains and clinical specimens" so that diagnostic makers can ensure the quality of the assays, but he warned: "That's not a simple thing to do."

As to whether FIND is positioned to develop such standards, Perkins said WHO put together 196 strains of TB from 81 nations in an effort to provide an exhaustive library of types for diagnostics makers to work with, but "for clinical specimens, that's an expensive business."

Another attendee remarked that aid organizations "have an abundant supply" of medical supplies and equipment, and that the problem is logistics within the nation that is the object of the aid effort. He said industry is "often na ve about how to get its product in" to a developing nation, and is subject to "sheer bureaucratic B.S." In most such nations, there is no federal agency or other central authority dedicated to ensuring that aid is placed where it is needed, and the lack of a designated responsible party almost seems to ensure that the donated items will sit in a warehouse or be sold by profiteers.

Perkins acknowledged "it's a huge problem," and even a company with substantial resources, like Becton Dickinson (Franklin Lakes, New Jersey) has difficulty just delivering needles and syringes.

"In the public sector, even in settings where there is a national ministry," he said, "supply management is a huge headache." However, he conceded that WHO does not have a ready solution to this dilemma. "WHO is not involved in supply chain issues," he noted.

Another attendee said that donor organizations might have better luck bypassing federal government entities and going straight to the locations where supplies and equipment are most desperately needed.

"The bureaucracy, the corruption" in India is growing worse, he said, adding that he was frustrated that WHO will not deal with a community and insists on dealing with the nation's ministry.

Perkins replied that he knows that "getting through the web of disinterested or corrupt parties is a challenge," but said his experience is that engaging those at high levels of government, as frustrating as it can be, works better than starting at the bottom.

"We can't necessarily solve problems of corruption, but we can't give up," he said.

Perkins said that while cost is a problem for poorer nations that are interested in obtaining diagnostics, compulsory licensing probably will not be much of a problem in most such nations. "The situation is quite different [from that of pharmaceuticals] because there is no such thing as a generic diagnostic." He pointed out that "there's a lot of know-how and art getting things to work," and most nations simply do not have enough trained engineers and others to manufacture a diagnostic.

Perkins said the question of technological competence for China is somewhat different, but even though the level of education there would allow the manufacture of a knock-off diagnostic, there is little incentive to do so.

"They don't obtain licenses from Roche" because much of what goes on in China is done via "home-brew" diagnostics, he said.

Perkins made the case that anyone in China who wants to make money manufacturing a patented diagnostic would find it easier to buy a license from the patent holder. In any case, patent piracy "hasn't come up on the radar screen," he said.

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