Medical Device Link.

IVD Technology Magazine
IVDT Article Index

Originally Published May 2000

EDITOR'S PAGE

Wanted: A room with a viewpoint

This special supplement marks the first time in the six-year history of IVD Technology magazine that the editors have had the opportunity to devote an entire publication to a single topic, and it's no accident that the topic selected is the field of molecular diagnostics.

For IVD manufacturers, the field of molecular diagnostics offers greater potential for industry growth than any other technology area. It is more fundamental than industry's gradual shift toward the development of point-of-care instrumentation, and it is more far-reaching than the creation of systems for total laboratory automation. In short, the potential of the field of molecular diagnostics is truly revolutionary.

In fact, taking advantage of the full potential offered by molecular technologies may turn out to be the biggest challenge of all. Already, with only a handful of commercial products on the market, researchers are exploring whole new fields of diagnostic medicine, such as pharmacogenomics and therapeutic drug monitoring. What new avenues will open up when genetic medicine begins to be practiced on a wide scale can barely be imagined, but it is certain that they will be heavily dependent on the development and eventual commercialization of molecular diagnostics.

To be sure, there are obstacles to the growth of this field. The investment community, has for the most part kept molecular diagnostics at arm's length, doling out funding warily, if at all. When large funding has been available, it has been through the investments and partnership interests of pharmaceutical companies that know very well the potential of the field. It is not clear what effect such parsimony may be having on the advancement of molecular technologies, but it certainly cannot be good.

Then there are the legal and ethical roadblocks that threaten to sidetrack or limit the development of the field. Among the key legal issues are those involving gene patenting and the protection of other key intellectual properties. Many companies in the field are already spending much of their time and capital on establishing or defending their patent rights, and such conflicts show every sign of getting much worse before they get better. Meanwhile, unaddressed public concern over issues of privacy and the use of genetic information continues to worry many in the field.

So far, industry has seemed not very interested in developing a unified view on such matters. But it is difficult to see how such a head-in-the-sand attitude can be beneficial for much longer. Groups that do not involve industry representation are coalescing around issues that have practical implications for manufacturers. Industry, unless it begins to express itself, may soon find that rules affecting the potential of the field of molecular diagnostics—and ultimately its products—have been drawn up in ways that are distinctly disadvantageous to manufacturers.

Ultimately, manufacturers will have to answer the call voiced by Debra Leonard in the roundtable interview that appears in this supplement. "Industry," she says, "has to form its own opinion about what should be done with the current patent system to prevent some of the problems that companies are encountering."

Gene patenting is only one such issue on which industry should begin to voice its view. There are many others, and now seems a good time to begin the process of formulating such positions.

Steven Halasey
steve.halasey@cancom.com