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Opinion: Diagnostics Needed

Resource-limited countries are in desperate need of better diagnostic tests for life-threatening illnesses.

By | January 10, 2013

WIKIMEDIA, PHR-ISRAELThe greatest obstacle to the care and control of diseases in the developing world is the absence of accurate and affordable diagnostic tests. This deficit can cause delayed diagnosis that lead to less effective and more expensive treatments, as well as the spread of disease to others. Worse, lack of sufficient diagnostics can result in misdiagnoses, improper treatment, and sometimes death. And even when diagnostics are available, they are often too costly, or at least more costly than the drugs to treat a perceived disease, further contributing to drug resistance.  The net effect is endangered lives, wasted resources, and the potential to create an even bigger health problem.

There are many challenges to achieving a successful diagnostic.  Being inexpensive alone is not sufficient.  It also has to be able to perform to high standards in challenging settings, such as villages across much of Africa where a small percentage of health facilities have access to a reliable power supply or towns and villages in the Indian subcontinent where operating temperatures are regularly above 40°C.  As a result, such tests have to be affordable, sensitive, specific, user-friendly, robust and rapid, equipment-free, and deliverable (ASSURED tests). Given all these challenges, developing new diagnostics for resource limited settings continues to be underfunded.

The potential to create inexpensive and effective diagnostic tests from a technological point of view should be achievable, however.  For example multiple tests for malaria and HIV, costing less than $1 each, have been developed.  Unfortunately, for more complex diagnostics offering testing for multiple diseases, especially those common in challenging environments, there are insufficient financial incentives to drive the development.  

In developed countries, where there is a clear pathway for access to profitable markets, manufactures are willing to make investments in diagnostics.  In contrast, there are multiple obstacles to achieve commercialization in the developing world, such as a complex regulatory approval landscape, weak health systems, and a chronic lack of funding for procurement in the public health sector.  Indeed, diagnostics represent a tiny portion of healthcare spending.  Malaria diagnostics, for example, received a mere 0.3 percent of the total malaria R&D funding in 2007, which increased notably in 2009, but still comprise less than 2 percent of the budget.  This level of support remains well below what is required for successful advancement of the field.  As effective diagnostics are required to support the development of other malaria control tools, a lag in diagnostic development will further impede the impact of investments elsewhere.

Furthermore, the successful development and roll out of point-of-care (POC) diagnostics is dependent not only on adequate funding, but also on the collaboration of many stakeholders, including the companies developing the products, the healthcare industry, and local governmental health ministries.   Recognizing this need, the Foundation for Innovative New Diagnostics (FIND) was created in 2003 as a Product Development Partnership (PDP).  Its mission is to develop and deliver innovative and affordable POC diagnostic tests for poverty-associated diseases, such as tuberculosis, malaria, sleeping sickness, leishmaniasis, and Chagas disease. 

To accelerate the development process, FIND maintains strong collaborations with a host of entities—manufacturers, academics, health organizations, donors, and ministries of health—and works with researchers from the initial design of a diagnostic test to its implementation in an endemic country. In tuberculosis, FIND's leadership role has resulted in the refinement and implementation of a diagnostic cartridge that provides countries with improved testing results. Within a year of its endorsement by the World Health Organization, more than 600,000 cartridges were procured by some 75 countries. FIND also recently announced the launch of the first rapid test for sleeping sickness.  This test has the potential to dramatically alter the manner in which the disease is managed by bringing a cost effective and easy testing to patients who often live in rural setting with minimal health infrastructure in sub-Saharan Africa. 

The use of inefficient diagnostics is an unacceptable situation that denies effective treatment to millions and places an enormous burden on health costs in those countries that can least afford it. Novel diagnostics permit measurement of the impact of programs designed to deal with these diseases.  Diagnostics allow for a baseline to be established and to track progress—you cannot manage what cannot be measured—and play an important role in the healthcare value chain.  There is no proper health intervention without the proper diagnosis.  

Mark Kessel is a partner of Symphony Capital LLC a private equity fund focused on drug development financing and Vice Chairman of the Board of Directors of FIND.

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Avatar of: jeenious

jeenious

Posts: 37

January 10, 2013

To what extent have we failed to seek to discover proxy evidence of specific disorders?

We have sought syndrome diagnosis in terms of clusters of symptoms and, from there in only a minority of cases (clinically at least), have sought to verify a specific etiologic agent of a particular patient's health issue:  viral, bacterial, physical insult, genetic abberation, lifestyle or work-related cause, extraordinary chemical exposure...

But to what extent have we sought for other proxies not readily associated with causes and effects of specific etiologies but which may occur in conjunction with it?

Fortunately today the time and cost of tests required to rule in or rule out a variable diagnosis are being reduce through advances in technology.  And the comparison and analysis and storage of thousands of case samples by computer hardware and software is increasingly possible.  (As time goes on, hopefull there will be more standardization of output, so that statistics from one source are compatible with, or interpretively correlatable to, those from another.  (This is not meant to obviate the fact that sometimes a novel approach to classifying data can reveal patterns that would not be as obvious as in another approach; so standardization for the sake of merging of statistics should not be sought for sake of uniformity for uniformity's sake alone.

There is a possibility that, among peripheral proxies that correlate to particular syndromes, there might be yet unrecognized correlative proxies, involving:

Specific body chemistry changes not yet deemed significant, but closely correlated to a specific pathology; or,

Specific intra-cellular process changes we are only on the cutting edge of being able to detect, observe, quantify, follow...; or,

Specific whole-body or local electro-chemical changes;

Specific neurological changes;

Specific intracellular process changes (these we are only at the earliest cutting edge of having technological access to quantify); or,

Specific epigenetic changes in sequences formerly considered to be "junk' DNA, that occur in whole-body or local pathological expressions of a pathology; or,

Specific changes in the varieties and kinds of intra-cellular or inter-cellular electrical valences that occur prior to, or during, or after a particular symptomology; or,

Specific responses of cells or intracellular processes to certain bands of electro-magnetic frequencies, peculiar to a given symptomology...

List representative, rather than exhaustive.

This is forward-looking, of course.  But face it, we are still foundering in the dark in diagnosing quickly some disorders, and assigning causes to them, which we certainly HOPE will be found more diagnostically deciperabe from proxies none of our technology so far has measured -- or technologies that COULD be developed from current knowledge, but which we have not yet thought to design in such a way as to measure.

In such areas as clinical oncology, we follow many protocols that are primarily maintenance-focused or paliative.  We surely can at least HOPE there lie in our future research and technology some new and different identifications of proxies for dianosing -- earlier, quicker and less expensive than at our present disposal -- but hopefully, too, the discovery of new and different proxy correlations might lead to new approaches to remedying pathologies that so far leave us wishing we had sufficient knowledge to effect cures.

Avatar of: Research!America

Research!America

Posts: 1

January 23, 2013

We often talk about the battle to improve global health in terms of the need to find new treatments or improve access. As pointed out by Mark Kessel, that’s not the whole story. More resources need to be devoted to point-of-care (POC) diagnostics, which link the right health care to the right patients in a timely manner, saving money and lives. FIND is not only working to fill this gap, it is demonstrating the accelerated progress made possible by collaborative efforts between the public, private and philanthropic sectors. 

FIND and other innovative product development partnerships (PDPs) are overcoming seemingly intractable problems in global health R&D – financing, bench-to-bedside delays, dissemination roadblocks – by harnessing the power of shared goals and broad-based capabilities. As an organization committed to advancing medical innovation in both the domestic and global arenas, we at Research!America are engaged in telling the story of PDPs in order to ensure the continued success of these high-impact partnerships. Polling demonstrates that Americans care about global health, and support continued federal funding – even in a challenging fiscal climate -- for global, as well as domestic, health R&D.

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