Low Cost High Performance Technology for Point-of-Care Diagnostics

Sponsor: Precision Photonics Corporation

• Project Performance Period: 11/1/2007 - 4/30/2010
• Total project (est.): $2,406,000.00
• Requested ATP funds: $2,000,000.00

Point-of-care (POC) diagnostics have the potential to revolutionize modern medical practice. This is particularly true in the developing world, where the lack of a healthcare infrastructure greatly inhibits effective care. There is no better example than the management of HIV-infected patients, where the lack of diagnostic tools prevents the efficient administration of desperately needed anti-retroviral drugs. POC diagnostics are also in demand in the industrialized world, where rapid, inexpensive testing can allow patient-specific therapies to be delivered and monitored. Yet "personalized medicine" has been slow to catch on, due in large part to the high cost and complexity of previous technologies. Precision Photonics Corporation proposes developing an extremely low cost technology that will enable a new generation of powerful POC diagnostic systems. The technology will consist of a novel fluorescent reader and disposable components that can be used for both cell-based and molecular assays. Innovations will include miniaturization of high-performance optics, new methods for making optical filters with broad imaging applications, and pump-free fluidics. The new technology will be demonstrated in a low-cost, compact, easy-to-use CD4+ cell-counting test to help manage HIV-infected patients in the developing world. Currently, CD4+ cell counting is performed using flow cytometry in centralized reference labs. Compared to flow cytometers, the proposed technology is expected to cut the cost of equipment by a factor of 100 and the cost of tests by a factor of almost 10. The proposed system should operate at less than $2 per test and deliver 1,000 times greater sensitivity than traditional lateral flow technology. ATP funding may accelerate the research by up to four years, enabling the technology to catch a window of opportunity in defining the standard of care for treatment of HIV. If successful, the new technology will help retain U.S. leadership in medical devices and high-precision manufacturing, and the low cost will promote personalized medicine in this nation and help assure U.S. competitiveness in emerging cost-driven markets such as China, Brazil, India, and South Africa.

For project information:

Mike Lochhead, (303) 444-9948
mike.lochhead@precisionphotonics.com

ATP Project Manager

Douglas Bischoff, (301) 975-8597
douglas.bischoff@nist.gov