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Electronics giants partner with IVD firms
In the worlds of clinical lab instrumentation and information systems, it seems that smaller is better. Like the computer industry, which has proven that a single integrated circuit (IC) chip can replace a room full of vacuum tube computer equipment, the IVD industry is working to develop single chips that can integrate numerous chemical manipulations. Some of the world's largest electronics companies have recently taken notice and are forming alliances with diagnostic firms.
Recently, Clinical Micro Sensors (CMS; Pasadena, CA) and Motorola BioChip Systems (San Diego) entered into a multiyear strategic alliance. "We intend to explore a number of markets including clinical diagnostics as well as biomedical, environmental, agricultural, and military research," says Dan Farkas, director of clinical diagnostics at CMS. "The timing of products released or launched in each of these markets will depend on regulatory factors and on the characteristics of the particular market being addressed." Motorola has provided an initial equity investment and has the option to invest additional funds in future financing of CMS.
CMS has developed and patented a technology for detecting and analyzing DNA and other molecules that uses low-cost, durable biochips. The process produces electronic results.
According to CMS, the partnership will explore the ways in which the latest developments in molecular research and distributed electronics can be used to detect and treat disease, manage food supplies, and protect the environment. Potential products could include those for use in the clinical and diagnostic industries, biomedical research, and pharmacogenomics.
One of the strengths that major IC-chip firms bring to their partnerships with diagnostic companies is their extensive experience in micromanufacturing. According to many analysts, manufacturing large volumes of DNA chips while also satisfying the requirements of FDA's quality system regulation has been a stumbling block that has restricted commercialization of the new technologies. But analysts believe that with the assistance and funding of partners from the IC-chip industry, a number of DNA-chip firms could soon break through the manufacturing logjam. With that obstacle out of the way, commercialization of molecular diagnostic systems could begin to come at a rapid pace.
According to CMS president and CEO Jon Kayyem, Motorola's strengths in the design and fabrication of electronic devices, as well as its chip-manufacturing capabilities, will help to make DNA analysis both routine and cost-effective.
Meanwhile, Hewlett-Packard Co. (HP; Palo Alto, CA) and Caliper Technologies Corp. (Palo Alto, CA) have forged a similar agreement to develop analytical and information systems based on Caliper's lab-on-a-chip technology. The goal of the alliance, which was initiated in May 1998, is to develop the first generation of miniaturized instruments that can integrate numerous chemical manipulations on a single chip.
According to Caliper, such systems are expected to improve laboratory productivity and to have applications in product development. Rick Kniss, vice president and general manager for HP's chemical analysis group, says that the partnership intends to develop instrumentation and chips that will help laboratory customers, as well as products that will enable diagnostics and pharmaceutical firms to slash their R&D time. "We expect a tenfold increase in the quality and amount of information generated as a result of this technology."
The worldwide market for microfluidic-based analytical systems is expected to be $1 billion early in the next century. With such a market at stake, it seems likely that more and more electronics and diagnostic companies will form alliances.—Susan Wallace
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