The past decade has seen increased recognition of the idea that, when appropriately organized and motivated, the public and private sectors can combine their different skills to solve problems that have not been adequately addressed by independent action. In global health, this has led to the development of product development partnerships: independent organizations that bring together a variety of actors to address research and development challenges using innovative methods. The ultimate aim of these partnerships is to develop affordable and appropriate products, including drugs, diagnostics and vaccines, targeted at the diseases affecting poor people in low-income countries.
One of these partnerships is FIND (Foundation for Innovative New Diagnostics) which focuses on addressing a specific fundamental gap in health systems: the ability to conclusively determine what disease a sick person is suffering from. This is a significant challenge for tuberculosis, a disease which was contracted by 9.4 million people and killed an estimated 1.7 million people in 2009. Diagnostics available in low-income countries are largely out-dated and ineffective, while those used in wealthier societies are either too expensive or inappropriate.
Lack of proper diagnosis costs patients and their families time and money, delays treatment and leads to continued TB transmission. Mounting drug resistance and a growing number of patients co-infected with TB and HIV have highlighted the urgent need for better tests.
MARKET FAILURES
While the need for new diagnostics is pressing and substantial, normal market forces have not pushed the commercial sector to invest in tools specifically directed at the needs of those who suffer from diseases such as TB; first because the populations affected are often seen as too poor to constitute an attractive market for commercially driven R&D. In addition, even companies that would be interested can be daunted by the lack of support structures for research (such as sample banks), and seemingly inconsistent and disordered local infrastructures in the affected countries.
This is where an organization like FIND comes in. FIND brings together disease-specific organizations, diagnostic companies, ministries of health, funders, local NGOs and others, and sustains partnerships between these often disparate groups with the specific goal of developing high quality diagnostics adapted to the needs of disease-endemic countries. This model has borne fruit: in seven years, five new products have been approved by the World Health Organization for the diagnosis of TB and multi-drug resistance.
The latest of these tools is the Xpert MTB/RIF, which takes accurate molecular testing out of central laboratories and brings it much closer to the patient. The new test, which was endorsed by the World Health Organization in December 2010, cuts the time to result for both TB and MDR-TB from weeks to less than two hours. It integrates sample processing, DNA extraction and amplification, providing highly sensitive and specific results with minimal needs regarding infrastructure and training for health workers.
During its scouting of the TB and technology landscapes, FIND came across the California-based company Cepheid, who had developed a robust molecular testing platform, GeneXpert. This machine was being used to test for anthrax in American post offices by non-medical personnel. Convinced that GeneXpert had potential for district laboratories in poor countries, FIND negotiated a partnership deal with Cepheid, and co-developed the test for TB and MDR-TB, along with the University of Medicine and Dentistry of New Jersey. FIND then organized various in-country trials to determine how the test would fare in real-life conditions, ranging from the slums of Cape Town to Azerbaijan, Peru and India.
The deal also included clauses on pricing, to ensure that the test would be available to the largest possible number of patients. These negotiated prices, based on the cost of production, are now available in 145 countries, and will continue to fall as global volumes increase.
LESSONS IN INNOVATION
GeneXpert is not a panacea, and there is a pressing need for continued innovation. Our highest priority remains for a simple tool suitable for the community level, where diagnosis is currently based on clinical symptoms only. This is where most patients first seek care, and where early treatment could have the greatest public health impact.
However, WHO estimates that the new test, which is already being rolled out by national governments in some of the most affected countries, could lead to a three-fold increase in the diagnosis of patients with drug-resistant TB, and a doubling in the number of TB/HIV cases diagnosed. It therefore fills a very large hole in the TB landscape, and clinicians in countries are already finding innovative ways to use the machine, including by linking it up to solar panels and carrying it around to remote areas to perform mobile screening. The development of GeneXpert demonstrates how innovation can take a variety of forms. Here, product development innovation was married with innovation in building partnerships. Over time, the model has become more granular, with more actors playing specific roles, but always with the common goal of developing a new technology to address a very specific need. The additional challenge we have had to take on in the past few years is to develop other types of innovative partnerships to ensure that the new tools aren’t simply dumped into disease-endemic countries, and that they are properly integrated into local system. Only then will they deliver on their ultimate promise of saving lives.
This article was written in 2011.
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