Open Competition 2 - Biotechnology

Portable DNA Analysis Device Using Real-Time PCR and On-Chip Electrochemical Detection

Sponsor: HandyLab, Inc.

• Project Performance Period: 7/1/2003 - 6/30/2005
• Total project (est.): $2,500,000.00
• Requested ATP funds: $2,000,000.00

An inexpensive, handheld, and real-time DNA diagnostic device (or "lab-on-a-chip") would fulfill strong demand in sectors such as health care, agriculture, food testing, and bioterror defense. Devices that use one or two miniaturized analysis components have been developed, but they are expensive, bulky, and incapable of processing raw clinical and environmental samples. HandyLab plans to develop a low-cost DNA diagnostic device the size of a personal digital assistant. This device will use a miniaturized yet ultrasensitive electrochemical detection system incorporated into DNA amplification - that is, a polymerase chain reaction (PCR) - chamber. This PCR and detection component then will be integrated with HandyLab's existing sample concentrator and cell lysis components using the company's proprietary microfluidic platform. Using novel electrochemical detection techniques eliminates the need for optical detection and associated equipment, thereby forming the basis of a new class of DNA analysis devices that are low cost and very portable. The University of Michigan (Ann Arbor, MI), a subcontractor, will perform experimental tasks involving electrochemical detection and biosensors. The project promises high payoff but entails high risk. Key risks lie in the miniaturization of the detection system and in the complete integration of all analysis components into a seamless microfluidic platform. Success rests on developing novel probes and signal amplification strategies and incorporating microelectrodes and electrochemical tags directly into the nanoliter-sized PCR chamber without inhibiting the reaction. While HandyLab has invested substantial funds to explore this lab-on-a-chip concept, the technology is considered to be at too early a stage for venture capital investment. ATP funding is needed to reduce technical risk, while reducing development time from eight to two years. A low-cost, real-time, and highly portable device for performing sophisticated and complex molecular testing could revolutionize health care in America by allowing doctors to diagnose genetically based diseases on the spot. Detection of food and environmental contaminants could be augmented. Law enforcement, military, and first-responder personnel could gain a valuable tool for bioterror defense and homeland security.

For project information:

Sanjeeb Das, (734) 663-4719
sdas@handylab.com

ATP Project Manager

Thomas Wiggins, (301) 975-5416
thomas.wiggins@nist.gov