In the developing world, a basic relationship exists between the need for diagnosis of infectious agents and their treatment. Diagnostics — which provide important information to aid physicians in the diagnosis, management, and treatment of myriad diseases — are critical for identifying communicable diseases that cause colossal morbidity and mortality. Properly designed diagnostics will enable the selection of medicines for treating infectious diseases such as HIV, TB, and malaria, along with a wide range of parasites, viruses, and bacteria; just as important, diagnostics thwart the over-use of medicines due to misdiagnosis, which is critical in the fight against the emergence of drug-resistant bugs.
The greatest need in the developing world is for molecular diagnostic tests that meet the requirements of cost, portability, and ruggedness for low resource environments. Molecular tests detect the presence of nucleic acids—DNA or RNA—from specific infectious agents. They are exquisitely sensitive and a successful platform could find broad applicability in the developing world, since the nucleic acid signature of each infectious agent is already known. So what prevents the many companies with such technology from developing a point of care (POC) molecular diagnostic platform?
One fundamental barrier is the lack of clearly identifiable market demand in the developed world. Companies are reluctant to spend tens of millions of dollars in product development if they do not have a reasonable forecast of recovering their investment and making a profit. Another barrier is cost. Portable technologies are available for selected indications in the developed world today, but the cost per test is too high for widespread utilization in the developing world.
One reason why molecular tests are common among rich nations is that there is a large infrastructure of centralized laboratories and sample transportation to support the diagnostics testing industry. The existing investment in central lab infrastructure biases future investments to take advantage of that sunk cost. But developing world markets have not made such a large investment, and just as they have for mobile phone technology instead of landlines, developing countries may jump over the step of infrastructural investment in favor of a network of decentralized laboratories that provide broader access to patients.
At BVGH, we believe that a financial incentive should be created to remove some of the barriers in order to engage innovative companies in product development for POC diagnostics that meet the needs of portability, ruggedness, and cost in the developing world. The financial risks that companies take on could be minimized by incentives that reward them for creating platforms and products that meet requirements appropriate for resource poor settings. In order to qualify for these incentives, companies would need to agree to basic principles ensuring access to these products in the developing world at a reasonable cost. One great benefit of the developing world is that there is a huge potential volume of product required, and large volumes can enable suppliers to reduce unit costs by developing automated manufacturing lines and amortizing the capital investment over large numbers of units. And reasonable cost needs to be defined by the health benefit the diagnostic enables as well as a final cost that supports a sustainable market.
What would an innovator get in return for such incentive funding? The successful company would have created a POC molecular platform that is robust, portable, and low cost—precisely the attributes that would enable new indications in the developed world markets. Such a platform could enable tests for malaria, Chagas, and onchocerciasis in low income countries—while at the same time serving as a basis for running tests for cancer and swine flu in middle and high income countries. We believe that CEOs and strategic thinkers within companies will support an appropriately designed incentive as something that benefits their overall corporate mission while serving the needs of the impoverished citizens of the developing world. And bringing companies with a successful track record of product development into global health is ultimately the best way to ensure that diagnostics are available to save millions of lives in the developing world.
David Cook is the Vice President of Business Development at BIO Ventures for Global Health.