‘Lab-on-a-chip’ diagnostic tool brings blood analysis to bedside

‘Lab-on-a-chip’ diagnostic tool brings blood analysis to bedside

Developer expects commercial release next year

Micronics, a developer of microfluidic technologies for laboratory diagnostics and chemical analysis, hopes to carve a niche for itself in the medical field by focusing on handheld devices that bring clinical laboratory diagnostic capabilities to the point of care.

The Redmond, WA-based firm has an exclusive license from the University of Washington to use the university’s microfluidic technologies for medical diagnostic applications. In microfluidics, small channels (hundreds of microns in diameter) are etched onto silicon chips, and fluids flowing through these channels are illuminated with a laser. Light scatter measurements are taken at multiple angles, and these measurements provide a “fingerprint” of various cells, including the size, shape, and internal structure of the particles detected.

This technology, known as flow cytometry, is not new. However, Micronics is implementing it on a microscopic scale using diode lasers and miniaturized optics originally developed for compact disk readers. The company’s goal is to develop a number of small, portable, easy-to-use diagnostic devices that mimic the capabilities of conventional desktop lab analyzers but at the point of care and in near-real-time.

“A few companies are starting to integrate chemical analytic functions on chips, but most are using this for high-throughput drug screening and that sort of thing,” said Bernhard Weigl, manager of business development and senior scientist for Micronics. “We have focused on clinical diagnostics.”

Micronics already has 15 patents related to its microcytometry technology and is in the process of developing its first commercial “lab-on-a-chip” product: a miniature hematology flow cytometer. The company is collaborating on this project with Beckman Coulter, a major player in automated lab instrumentation. Micronics is designing the chip, the fluid driving system, and some of the interfaces, while Beckman Coulter is responsible for the optics, electronics, and software.

The handheld device uses a 620-nm diode laser in conjunction with a microfluidic chip, detector, and analytical software to perform a five-part differential blood count of a single drop of blood—equivalent to what state-of-the-art hematology analyzers do, according to Weigl, but at the bedside instead of in a remote laboratory. Early versions of the device will be about the size of a toaster, but they will be fully self-contained (including the software). Weigl anticipates the system will eventually be moved onto a PDA platform.

“We are taking these functions out of the lab and into the field,” he said. “We believe this will be the first true point-of-care hematology instrument.”

In fact, the Micronics product is intended to compete head-to-head with conventional lab analyzers, which can run hundreds of samples per day but are larger, cost more ($100,000 to $500,000 vs. $10,000 to $20,000), and use considerably more sheath fluid (the fluid that runs through the channels). In addition, the Micronics device enables physicians to obtain results in under a minute, either on a small computer screen or via a printout. While large lab analyzers can also produce results within minutes, most physicians do not have such analyzers, or the trained medical technologists to operate them, in-house.

“Our technology will enable physicians to get results when and where they need them,” he said. “Time is not always the issue; convenience is important as well. Sometimes you need to get results when you have the patient right in front of you.”

Micronics anticipates beginning clinical trials by mid-2001, with commercial release by the end of 2001. The company is also negotiating other partnerships to develop this technology for bacteria detection, food testing, and other applications that could benefit from the detection and characterization of particles.

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