Harvard University and Diagnostics-For-All, Inc., (DFA) have entered into an agreement aimed at developing a new generation of portable, low-cost, user-friendly diagnostic solutions and make this technology accessible to patients and healthcare providers in the developing world.
DFA is a not-for-profit diagnostic device company launched to develop a low-cost, paper-based “lab-on-a-chip,” a simple and flexible diagnostic device that can be used in resource-poor areas of the globe to support public health. The DFA took top honors at Harvard Business School’s 12th Annual Business Plan contest in April and at the 2008 MIT $100K Entrepreneurship Competition in May.
DFA was formed as a non-profit organization because this approach was deemed to be the most likely to succeed in meeting the needs of citizens in developing countries. Under the arrangement with Harvard, DFA will have the option to exclusively license the diagnostic technology from Harvard royalty-free for not-for-profit purposes.
“With the dire state of healthcare in much of the world, Harvard is strongly committed to acting with flexibility and speed to improve global health,” said Isaac T. Kohlberg, Senior Associate Provost and Chief Technology Development Officer at Harvard University. “This partnership will help facilitate broad global access to these important Harvard inventions, which have the potential to positively impact the way health care is delivered to millions of people throughout the world.”
The technology, developed in the laboratory of George M. Whitesides, Ph.D., the Woodford L. and Ann A. Flowers University Professor, Department of Chemistry and Chemical Biology at Harvard University and a co-founder of DFA, starts with a paper-based microfluidic chip the size of a fingernail, pre-treated with reagents for color-based (or colorimetric) assays that can be used to test bodily fluids (e.g., blood, urine, sweat) for proteins and other molecules indicative of health or disease. The paper is patterned with hydrophobic polymers, forming a series of channels that guide a fluid sample to the pre-treated regions of the chip. The resulting color changes can then be read and translated into a diagnosis using a key tied to the particular test being conducted.
The chip offers several advantages over point-of-contact diagnostic systems currently being developed or employed in the developing world. First, the use of paper means the chips could be significantly cheaper—potentially as low as 1 cent per chip—than other microfluidic designs, which are generally based on silicon, plastic, or glass. Second, the technology is highly portable. No specialized equipment is required to process and read samples once they are applied to the chip, and because it takes advantage of the natural capillary action of paper, the device does not require complex pumps or power sources.
Second, DFA’s device is user-friendly. The assays are color-based, and the results can be read within minutes with minimal training using a color-coded key. Finally, and of great significance for the environments in which the chip will be used, it is easily and safely disposable. After use, the chips can simply be incinerated, eliminating the need for access to resources for biological waste disposal.
The company envisions developing regional diagnostic networks made up of individuals trained to conduct tests using the chips, linked via cell phone to doctors who would advise on diagnosis and treatment.
"What we have with this technology is the means to help address significant diagnostic disparities between the United States and the developing world," said Whitesides. "For instance, over time about five percent of patients in the developing world receiving treatment for tuberculosis or AIDS—equivalent to approximately one million people—will succumb to drug-related liver complications because of a lack of proper health monitoring. In the US, tests for these complications are conducted every two weeks, with results returned within hours. In the developing world, when these tests are done, which is rarely, it can take laboratories weeks to send back the findings.
"By developing a low-cost and broadly-applicable test system designed to be deployed in regions with no or little access to complex laboratory diagnostic equipment," Whitesides continued, "we hope to make a real impact on public health."
In addition to its recently hired Executive Director, James Barber, Ph.D., former President and Chief Executive Officer of Metabolix, Inc., DFA’s Board of Directors is composed of veterans in the development of biomedical technologies, including:
- George Whitesides, Co-Founder and Chair of DFA’s Scientific Advisory Board, and the Woodford L. and Ann A. Flowers University Professor, Department of Chemistry and Chemical Biology at Harvard University
- Carmichael Roberts, Ph.D., Co-Founder and Chair of DFA’s Board, and General Partner at North Bridge Venture Partners
- Hayat Sindi, Ph.D., Co-Founder, Director of DFA, and Visiting Scholar at Harvard University
- Isaac T. Kohlberg, Senior Associate Provost and Chief Technology Development Officer, Harvard University