Paper-Based Diagnostics for Pennies
Harvard University and Diagnostics for All have developed a postage-stamp-sized paper diagnostic test based on paper-microfluidics. Place a drop of the sample (e.g. blood, urine, saliva) on the paper, and within minutes the color change on the paper allows for a diagnosis. The first product using this technology is targeted at HIV/AIDS and TB patients who are treated with strong drugs that are toxic to the liver. Many of these patients are at risk of death from liver complications caused by the treatment itself, not from the disease. For pennies, a quick and easy test for liver function will now be available.
Photo credit: Diagnostics for All
If health care workers in developing countries had access to cheap diagnostic tests that could be administered easily, and the results determined right there on the spot - it would mean a revolution in diagnostics for the poor. But this requires a complete re-think of currently available diagnostic testing. Rural clinics in developing countries often lack trained professional technicians, and they must operate with limited access to reagents, no refrigeration or reliable power supply, limited supplies of sterile syringes, and no expensive equipment on which to perform tests.
There are a range of promising products being developed in the diagnostics space, including: low-cost alternatives for centrifugation that use magnetic beads instead of expensive lab equipment; battery-powered, rapid techniques to replace current nucleic acid amplification without the need for thermal cycling; nano-biosensors capable of directly detecting low levels of microbes in a sample within seconds; and the use of paper-microfluidics to create paper-based instant-read diagnostics for the cost of pennies. In each of these categories there are examples of technologies that are in the market or in late stage development – and each provides an interesting case of how intellectual property rights in advanced science and technology has been used to benefit the poor.1 Here we focus on a paper-based point-of-care diagnostic test.
Harvard University and Diagnostics for All have developed a postage-stamp-sized paper diagnostic test. Place a drop of the sample (e.g. blood, urine, saliva) on the paper, and within minutes the color change on the paper allows for a diagnosis.
The device uses paper-microfluidics. The paper is etched with small conduit lines and with assay zones filled with chemical or biological assay reagents corresponding to the test to be conducted. The paper wicks the drop of liquid through the channels onto the assay zones, without the aid of pumps or power. In a matter of minutes, when the drop contacts the colormetric assay zones, they will change color, so that without need for special skill or training one may compare the result with a reference scale printed on the device.
The first product using this technology is targeted at HIV/AIDS and TB patients who are treated with strong drugs that are toxic to the liver. Many of these patients are at risk of death from liver complications caused by the treatment itself, not from the disease. Such complications are rare in developed countries where the patient’s liver function is regularly monitored, but can be fatal for patients in developing countries where there is no diagnostic supervision.
In many cases, this could be avoided by quick diagnosis. The screening test used until now has been fairly simple, but requires resources that are out of reach to the millions of patients in the developing world. The paper-based liver test has been specifically designed for the developing countries – no refrigeration, easy and fast to read, and costing only pennies.
DFA notes that the development of this first device provided valuable experience which they intend to put to good practice in developing further devices for a broader range of assessments of patients and of diseases. DFA’s leadership in this field receives much acclaim and they have received further grants to develop also agricultural diagnostic tests.
The IP Strategy
Harvard University entered into an agreement with the nonprofit enterprise Diagnostics For All, Inc. (DFA), granting DFA royalty-free, exclusive worldwide rights to certain diagnostic technologies that were developed in the laboratories of Professor George Whitesides at Harvard University and for particular applications. Whitesides is co-founder of DFA and the development of the technology was supported in part by a grant from the Bill and Melinda Gates Foundation.
According to the head of Harvard’s Office of Technology Development, "The license granted to DFA represents the commitment of Harvard University to assure that new technologies developed at Harvard are deployed and used to benefit the world’s neediest populations. As a leader in university technology transfer, Harvard has an obligation, consistent with its academic and public service mission, to help serve the disadvantaged and the developing world, thereby benefiting society."
The license to DFA includes rights to sub-license, with Harvard University receiving a small portion of sub-licensing royalties. This is important, as the technology has a wide variety of applications, including those outside developing countries. In developed country markets, applications include: pediatrics, emergency response, veterinary medicine, military use, environmental control and public health, and more.
In addition to potential future royalties from the IP, DFA will create revenue from sales of its products. Brokering a deal in which DFA can benefit from royalty streams, and income from the diagnostic tests (which are affordable, but not free) allows for a sustainable model - continuing to serve health needs beyond the time when initial donor support is gone. Whitesides is quoted as saying: "We're trying to develop a system by which this activity becomes self-supporting...Ultimately, even in the developing world, somebody has to make money from it. If these things are useful, they should pay for themselves. Philanthropic institutions should be in the business of getting stuff started, but not paying for it forever.
Brokering a deal in which DFA, as a not-for-profit organization, can benefit from sub-licensing royalty streams, as well as some income from the affordable, but not free diagnostic tests allows for a sustainable model - continuing to serve health needs beyond the time when initial donor support is gone.
1 Peeling, RW and D Mabeys, Point-of-care tests for diagnosing infections in the developing world, Journal Compilation, European Society of Clinical Microbiology and Infectious Diseases, CMI, 16, 1062–1069, 2010.
Photo credit: Bill & Melinda Gates Foundation