IVD Technology
Magazine
IVDT Article Index
Originally published May, 1998
Editor's Page
The siren song of new technologies
It's easy to be seduced by the lure of promising new technologies. But for manufacturers of in vitro diagnostics, it takes more than a lot of gee-whiz gimmicks to make a successful run at the marketplace.
Consider the comment of one high-tech researcher, explaining why a Silicon Valley competitor had gone out of business. The company's directors, he said, suffered from a common malaise: "They came down with 'Here's a neat toy from a university — let's make a company' syndrome." Despite having a promising technology, the company soon found that it did not have the wherewithal to develop a marketable product.
So where are IVD manufacturers finding out about viable new technologies? One place is at showcases such as the American Association for Clinical Chemistry's annual Oak Ridge Conference, which carries the permanent subtitle "Tomorrow's Technology Today." This year's installment, cosponsored by IVD Technology, lived up to that billing — and perhaps a little more. Held last month in Raleigh, NC, the conference this year took as its theme "The Miniaturization of Analytical Systems: Chip-Based Technologies for the Clinical Laboratory." The list of advanced technologies presented at the conference is a long one, including the following:
- The prototype of a pipettor microchip capable of reconstituting solid-phase reagents and aspirating them for use in on-chip sample analysis (Anne Kopf-Sill, Caliper Technologies, Palo Alto, CA).
- Low-cost methods for rapid fabrication of microfluidic chips in plastic (Laurie Lacascio, National Institute of Standards and Technology, Gaithersburg, MD).
- A miniaturized lateral-flow assay that uses a microfabricated surface architecture in place of a membrane (Kenneth Buechler, Biosite Diagnostics, San Diego).
- Introduction of the Liquid Northern assay, using mass spectrometry for high-throughput multiplexed gene-expression analysis (Joseph Monforte, Gene Trace Systems, Menlo Park, CA).
- An active microelectronic DNA chip for rapid multiplexed hybridization analysis (Michael Heller, Nanogen, San Diego).
- A microfabricated DNA target preparation cartridge that can position, meter, link, mix, and thermally cycle fluids without the use of on-board sensors (Rolfe Anderson, Affymetrix, Santa Clara, CA).
Such achievements are unquestionably impressive. Surveying the field for his keynote address at the Oak Ridge Conference, Larry Kricka (University of Pennsylvania, Philadelphia) suggested that the current pace of technological development is certain to bring about marketable miniaturized diagnostic products in the near future.
But will such products constitute the revolution in diagnostic practice that many have predicted? On that question, the jury is still out. Kricka admitted that not all such technologies would be likely to push diagnosis out of the clinical laboratory and into the hands of home users. "You'll still have benchtop units that are recognizable as instruments," he said, "but perhaps when you open them up, the inner workings will be those produced by nanotechnology."
In the meantime, researchers still have a fair number of technological challenges to overcome. Many miniaturized systems, for example, rely on the accurate dispensing of extremely small volumes of reagents onto substrates that are not always amenable to the task, as discussed in Tom Tisone's article in this issue. And miniaturized microchips may also raise issues related to their processing, biocompatibility with samples, and sample collection procedures — all of which product developers will have to sort out.
Keeping a close watch on the emergence of such technologies isn't easy; it requires regular attendance at important conferences and trade shows and continual attention to publications such as our own. But doing so is the best protection that IVD manufacturers have against running their companies aground on the shores of an unproven technology.
Steven Halasey
