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What's in a name?
When laboratorians and industry researchers come together in April for the American Association for Clinical Chemistry's Oak Ridge Conference, they should have a lot to discuss. Traditionally a setting where new technologies for the clinical laboratory are presented, the conference has this year taken on the theme of noninvasive testing—a fast-paced field that is rife with competitors.
One session likely to keep attendees in their seats—if not on the edge of their seats—is the conference's final panel discussion on the future of noninvasive blood glucose monitoring. The question that panelists will be asked to address is the one most on the minds of manufacturers and laboratorians alike: how far off is FDA approval of a truly noninvasive monitor? Coming at the end of a full day of sessions on new technologies for glucose monitoring--some of which are discussed in this issue of IVD Technology (see page 12)—the Oak Ridge panel seems guaranteed to offer a lively interchange of views about the merits of such technologies.
One company not represented in the Oak Ridge program could turn out to have the most interesting story of all. Cygnus Inc. (Redwood City, CA) has long been considered a front-runner in the race to develop a noninvasive glucose monitor, using the GlucoWatch technology described in this month's news story. But just as that news story was going to press, at the end of January, Cygnus unexpectedly announced that it had filed the first part of its premarket approval (PMA) application with FDA. According to company sources, the filing was made a full month ahead of schedule, and will help to keep the company on track for a June filing of the remaining PMA materials.
In the meantime, of course, other companies are continuing to pursue alternative solutions to glucose monitoring. At the end of February, FDA's clinical chemistry and clinical toxicology devices panel unanimously recommended approval of Minimed's PMA application for a continuous glucose monitoring system. Minimed's system is far from noninvasive; the key components of the system are a subcutaneous glucose sensor and an external unit for storing data generated by the sensor. If approved, however, Minimed's device will become the first continuous glucose monitoring system on the market, thereby raising expectations for products from other companies in the field. Minimed will be among the companies presenting a session at the Oak Ridge Conference.
Although glucose monitoring heads the list of areas for which IVD manufacturers are developing noninvasive technologies, it is not the only one. In fact, if industry watchers are correct, such technologies could eventually redefine the very notion of what constitutes an IVD. When diagnostics reach the point where testing results can be generated entirely through hardware and software, without any tissue or fluid samples and without the use of chemical reagents, it may be a stretch to continue thinking of such devices as "in vitro" diagnostics.
We aren't considering a change in our title yet, but let's hear what the presenters at this year's Oak Ridge Conference have to offer. Then we'll talk.
Steven Halasey
