Editor's Page
Hot . . . or not?
A few months ago, I had the pleasure of writing the cover story on clinical diagnostics for our sister publication, Medical Device & Diagnostic Industry. This was an assignment I relished, in part because it gave me an opportunity to talk with lots and lots of IVD manufacturers and to learn about the kinds of products they are developing.
Needless to say, automated systems were high on the priority list. Such systems include small laboratory analyzers and point-of-care devices with specialized sample-handling capabilities, as well as large total laboratory automation (TLA) systems that can integrate and automate virtually every step of a clinical laboratory's operations. At both ends of the scale, these systems are responding to the call of the marketplace for greater accuracy, higher throughput, and reduced costs.
How this trend toward automation is playing out, from a manufacturer's point of view, is the subject of this issue's cover story by Jack Zakowski and Diane Powell. While noting that fewer than 20 laboratories in the United States have adopted the TLA approach, the authors also observe that labs that want to stay in business will need to adopt some form of automation in the not-too-distant future. "If they don't," the authors conclude, "they will not survive the current downsizing and consolidation that is affecting clinical laboratories across the nation." For manufacturers, this trend represents a clear market need that they can aim to satisfy—but it's far from the only important trend on the block.
One of the business assumptions that underlies the continued development and elaboration of automated systems is that clinical testing will, for the most part, continue to be carried out in a laboratory. That may be true in the near term, but it may not always be so—as suggested by Glen Frieberg's article on FDA's first approval of a tumor-marker test for prescription home use. In reality, there is significant economic pressure in favor of patient self-monitoring, especially for chronic or potentially recurring conditions, and the menu of tests and devices approved for home use is continuing to grow. By approving Bion's tumor marker for such an intended use—in part because of its clinical utility for reducing the cost of patient care—FDA has thrown in with those who see the consumer as the next great market for medical products, including diagnostics.
Fortunately for manufacturers, such differing approaches to diagnosis and monitoring, though competing with one another, are not mutually exclusive. In order for clinicians to provide the best possible medical care, they must have access to a wide variety of tools—and such a variety is something that the IVD industry provides in great abundance. Later this month, manufacturers will have a chance to show off their competing systems at the annual meeting of the American Association for Clinical Chemistry (AACC) in New Orleans. Suppliers to the industry will be there too, demonstrating the vital role that they play in advancing the state of the art for IVDs.
As always, it will be interesting to see what's new, what's hot, what's selling, and what's not. We'd also like to hear what you think the future is bringing, so while you're at the AACC meeting, please stop by and see us at the IVD Technology booth, #3261.
Steven Halasey
steve.halasey@cancom.com
