Center for Global Health R&D Policy Assessment

Compared to drugs and vaccines, diagnostics are often overlooked as a critical health technology. Even though they don’t directly treat disease or confer immunization, they play a number of important roles in controlling disease. Some of these roles were pointed out at the “International Conference on Technological Challenges in Developing Affordable In-Vitro Molecular Diagnostics” which took place in Navi Mumbai this past week. The conference brought together top academics, policymakers and companies from within and outside India to discuss the latest advancements in diagnostics research.

As the presentations unfolded and researchers discussed their new findings, it became clear that diagnostics have important functions for both individual patients and broader public health efforts, and that Indian researchers are increasingly turning their attention to tackling challenges in diagnostic research and development.

A key tool for improving public health
For patients, a good diagnostic can identify a disease and lead a healthcare provider down a rational treatment path. Although a test itself may be cheap and quick, it influences a much broader set of healthcare decisions. Of course, a bad diagnostic can lead to missed cases of disease or the prescription of ill-suited treatments, as is the case with the use of ineffective TB serodiagnostics.

One of the most important uses for a diagnostic in the public health system is to help establish a reliable disease burden. Accurate measures of disease allow policymakers to better prioritize spending and concentrate their efforts on the most pressing needs. Without accurate data, policymakers are crippled. Dr. Vijay Kumar of the University of Buffalo illustrated this with the case of Celiac’s disease which has been previously under-reported in both the US and India. Before there were simple screening methods for the disease, Celiac’s disease was considered extremely rare, and patients had limited options to manage the condition. Subsequent research has found that clinicians missed cases of the disease since it presents various clinical manifestations and instances where patients are outwardly asymptomatic. Improved methods of detection suggest that the burden is as high as 1 in 133 in the US. This has brought new public health attention and general public awareness to the disorder, sparking a billion dollar gluten-free food industry and a range of patient support services.

For infectious disease, diagnostics help curb the spread of drug resistance by allowing healthcare providers to limit treatment to those who are actually afflicted with the disease and by verifying whether a patient has been cured or not. On the flip side, an inaccurate diagnostic can directly contribute to the growth of resistance by perpetuating the improper provision of drugs.

The sum of these affects on the public health system suggests that a good diagnostic is worth much more than what a patient pays, and the development of new and better diagnostics for global health is of the utmost importance. On a policy level, these insights have important implications. When the benefits to society are greater than those to individuals alone, public subsidies may be warranted to reduce the cost to individuals and encourage the uptake of effective and accurate diagnostics.

Achieving better diagnosis: Diagnostic R&D
In addition to encouraging the uptake and use of existing technologies, ensuring widespread accurate diagnosis also requires better diagnostics. In India it’s not always enough to come up with new tests; ideally, the diagnostics should be low-cost, point-of-care and easy to transport in order to complement the decentralized system of healthcare delivery. Luckily, the science of diagnostics is on the move, and the Government of India is investing heavily in the expansion of biotechnology research. Conference participants presented their research from disciplines such as genomics, proteomics and transcriptomics—all cutting-edge fields of biotechnology that have only gained traction in the past two decades. Most of the questions that participants posed to each other uncovered potential to expand the breadth and depth of one another’s work, suggesting that there is still much to explore for diagnostics. The opportunities are numerous, and diagnostics R&D demands the best minds. The path forward, however, is not so simple. Conversations with some of the conference participants suggest that the field is fragmented and often country-centric. Researchers are familiar with the funding programs and companies active in their region, but have limited knowledge of potential opportunities abroad. Companies in India face similar difficulties in identifying potentially commercializable work in the public sector.

In addition, funding for diagnostic R&D is limited, especially in India where domestic financing is difficult to secure. Diagnostics comprise a small portion of total biomedical R&D, and the picture is bleaker for global health. The latest Gfinder found that about $179.2 million was spent on diagnostic and platform R&D for global health in 2010, which is less than 6% of all global health R&D spending. For diagnostics with a large potential market firms may find ways to overcome challenges in financing and fragmentation within the field, but for global health, public-private partnerships play an invaluable role by bridging funding gaps and locating opportunities to develop needed technologies.

The product-development partnership (PDP) model used by groups such as FIND and PATH, who are behind technologies like Gene Xpert, LAMP, and new low cost diabetes screening methods, is one of the most familiar kinds of partnerships. Direct grants or soft loans to companies, such as Gates Foundation’s Grand Challenges grants or funds provided through the Indian government’s Small Business Innovation Research Initiative, can similarly help engage companies in focused diagnostic R&D for global health. In India, the expansion of public and private health insurance plans, which demand accurate and cost-effective diagnosis, may also strengthen the industry.

Seeing conference participants from companies and research institutes spanning countries eagerly try to forge partnerships and explore one another’s work, it became apparent that information is another basic need for bringing public and private interests together. Dr. Jouko Haapalathi of Orion Diagnostics and Salwe Ltd in Finland presented on the Finnish “SHOK” model. A SHOK is an independent company driven by a defined translational research agenda whose equity is shared between private companies and the government. Each SHOK is focused on commercializing and diffusing new technologies in a specific field by linking companies with public researchers. Though this model has only been applied within Finland, pieces of it may have broader applicability to global health.

A group could serve as a “network of networks” to stay on top of the latest scientific advancements and commercial opportunities and build connections where useful. Unlike a PDP, a SHOK is not limited to pursuing non-profit projects even though it receives public investment. Such an arrangement focused on India could help connect the country’s vast landscape of public research institutes and biotech companies. A common place for researchers to share their latest assays and discuss technical challenges, for companies to highlight platforms in development, and for funders to lay out product procurement priorities could help unlock some potentially useful global health collaborations.

The conference concluded with a sense of enthusiasm and opportunity. Participants felt that many new and important diagnostics for both communicable and non-communicable diseases will emerge in the coming years. The presence of so many young Indian scientists, budding diagnostic companies and international partners is a hint that India can play an important role in creating new health technologies and facilitating the exchange of ideas across borders, but harnessing this energy for global health will require targeted international and national policies and partnerships.