Harvard University and the nonprofit Diagnostics-For-All Inc (DFA), both of Cambridge, Mass, plan to develop a new generation of portable, low-cost, user-friendly diagnostic solutions that can be tapped by patients and health care providers in the developing world.

The diagnostic-device firm’s mission is to create an inexpensive, paper-based, lab-on-a-chip—a simple, flexible, diagnostic device that could be used in resource-poor areas worldwide to support public health.

The company snagged top honors at Harvard Business School’s 12th annual business plan contest in April and at the 2008 MIT $100K entrepreneurship competition in May.

Its nonprofit status was deemed most likely to meet the needs of citizens in developing countries. The agreement between the partners gives DFA the option to exclusively license the diagnostic technology from Harvard royalty-free for not-for-profit purposes.

“With the dire state of health care in much of the world, Harvard is strongly committed to acting with flexibility and speed to improve global health,” said Isaac T. Kohlberg, Harvard’s senior associate provost and chief technology development officer. “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 lab of George M. Whitesides, PhD, the Woodford L. and Ann A. Flowers university professor, department of Chemistry and Chemical Biology at Harvard and a co-founder of DFA, starts with a paper-based microfluidic chip the size of a fingernail. The chip is pretreated with reagents for color-based (or colorimetric) assays that can be used to test bodily fluids (such as blood, urine, and 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 pretreated regions of the chip. The resulting color changes can 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 being developed or in use in the developing world. 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. The technology is highly portable. No specialized equipment is needed 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.

DFA’s device is user-friendly: The assays are color-based, and results can be read within minutes with minimal training using a color-coded key; it is easily and safely disposable—a big plus for areas where it will be used; and after use, chips can be incinerated, eliminating the need for access to resources for biological-waste disposal.

The company plans to develop regional diagnostic networks staffed by people who are trained to perform 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. "Over time, about 5% of patients in the developing world receiving treatment for tuberculosis or AIDS—equivalent to approximately 1 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 2 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, we hope to make a real impact on public health," he added.

DFA’s board is comprised of veterans in the development of biomedical technologies, including:

•    James Barber, PhD, former president and CEO of Metabolix Inc, Cambridge, Mass, and DFA’s recently hired executive director

•    George Whitesides, co-founder and chair of DFA’s scientific advisory board

•    Carmichael Roberts, PhD, co-founder and chair of DFA’s board, and general partner at North Bridge Venture Partners, Waltham, Mass

•    Hayat Sindi, PhD, co-founder, director of DFA, and visiting scholar at Harvard
•    Isaac T. Kohlberg, senior associate provost and chief technology development officer at Harvard