Diagnostics For All Set To Take The Field For Clinical Trials

Article preview from Start-Up - February 2011

Not-for-profit start-up Diagnostics for All is set to begin a field trial in Kenya in March to evaluate a postage stamp-sized disposable diagnostic device to assess liver function in AIDS and TB patients. But the company eschews the notion that it's a charitable endeavor. Rather, it has crafted a licensing deal and business model that anticipates leveraging its not-for-profit work into a sustainable commercial First World business.

Diagnostics For All Set To Take The Field For Clinical Trials

Article preview from Start-Up - February 2011

With more than $10 million in funding from the Gates Foundation and other grant sources and a network of volunteer professionals to bolster its six-person staff, not-for-profit start-up Diagnostics for All (DFA) is set to begin a field trial in Kenya in March to evaluate its energy- and water-independent, postage stamp-sized diagnostic device to assess liver function in AIDS and tuberculosis patients. But the company, launched out of the Harvard University laboratory of George Whitesides, PhD, eschews the notion that it's a charitable endeavor. Rather, CEO Una Ryan, PhD, and Harvard have crafted a licensing deal and business model that anticipates leveraging its not-for-profit work in the developing world into a sustainable commercial First World business.

DFA is built around a Whitesides' technology for running clinical chemistries and immunoassays using a single-use disposable. The device is formed by printing layered patterns of microfluidics channels on water-repellent paper using wax. Each layer is stamped with a different pattern, basically creating a series of wells in which different reagents are deposited. The paper "wicks" a body fluid – blood, urine, sweat, or tears – so that the sample flows along the channels, where it is exposed to reagent, without the need for a pump or other energy source. Within minutes, the device provides an easily visible colorimetric readout. It's also possible to extend applications by incorporating LEDs, photodiodes, and ribbon batteries that are bendable and flexible onto the paper – to create a disposable glucometer, for example. Even the most sophisticated of these iterations should cost no more than pennies to produce, says Ryan. The technology could even be incorporated into threads, for use in wound dressings to indicate infection, or in panty liners and diapers to identify infectious agents.

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