Originally Published IVD Technology May 2002
Editor's Page
Word of the
day
A
few years ago, FDA established two new classifications for IVDs not yet cleared
for commercial launch: investigational use only (IUO) and research use only
(RUO) products. The creation of these categories defined the status of products
that had hitherto lingered in limbo—something quite a bit more than mere
commodity reagents, but still quite a distance from being actual diagnostics.
It also acknowledged the market reality that exists for many IVD manufacturers,
for whom the nonclinical and research applications of such products can sometimes
generate as much revenue as approved diagnostic sales.
Outside Rockville,
in fact, FDA's bright line between approved commercial diagnostics and
mere research tools is a blurry one at best. When applied in areas such as environmental
monitoring or food safety testing, for instance, even unapproved technologies
initially developed for use in human diagnostics can take on an entirely new
significance. No longer IVDs in the strictest sense of the term, such products
can nevertheless bring to other fields sophisticated testing techniques that
were previously unavailable outside the clinical arena.
Some IVD manufacturers
have been exploring such applications for years, conducting R&D and sharing
test results with veterinary companies, food processors, and government agencies
to improve the quality of tests available for their use. But such relatively
low-key forays into nonclinical areas will likely pale in comparison with what
is to come now, when the watchword of the day is biodefense.
The new emphasis
on biodefense that has emerged since the terrorist attacks of September 11 has
resulted in a sudden shift in the character of the R&D being carried out
by developers of nonclinical tests. Environmental monitoring now includes being
able to detect and identify insidious agents deliberately introduced into waterways
or agricultural crops; veterinary testing means watching for the intentional
spread of infectious agents that could decimate domesticated livestock; and
food safety testing means guarding against any plan purposely meant to adulterate
food supplies.
In this issue, IVD Technology takes a look at some of the technologies now being developed for nonclinical testing applications—including biodefense ("A whole new world" and "IVD systems in bioterrorism response"). It's clear that IVD manufacturers are already doing a great deal in these areas—but if these articles are any indication, there's plenty more to come.
Copyright ©2002 IVD Technology
