Originally Published IVD Technology June 2002
Editor's Page
Don't take this for granted
The
discovery of biochemical and genetic markers with potential clinical utility
is a worldwide effort that involves academic, clinical, and industry researchers
working in a wide variety of settings. There's no question that the markers
discovered and studied by such researchers represent the fundamental components
of IVD testing. Put simply, without a useful marker there can be no test.
Nevertheless, there
are limits to the importance of such clinical markers. It is not, for instance,
the continued discovery and refinement of markers that has given shape to modern
practices in clinical testing. Knowledge of the appropriate markers hardly explains
how it has come about that diabetic patients are able to monitor their blood
glucose levels using portable monitors, or how emergency room physicians can
now determine a patient's cardiac status hours earlier than ever previously
possible—or how both of these testing functions can be carried out without
the intervention of a clinical laboratorian.
Nor can the proliferation
of useful markers, by itself, explain the gradual rise of the global market
in IVD testing. Today, commercialized tests are making clinical diagnosis and
monitoring possible in sites far from clinical laboratories. And even in locations
where labs exist in abundance, commercially available tests are helping to increase
convenience, improve patient compliance, and reduce testing costs.
To a very large
extent, such characteristics of the modern healthcare system are a result of
one thing: manufacturing. Put with a little more complexity, without the means
to manufacture consistent products in mass quantities, modern clinical testing
would be impractical.
Manufacturing a
commercial IVD test requires efforts of a different magnitude from merely producing
a single test in a laboratory environment. It requires the manufacturer to procure
or produce high-quality reagents with consistent characteristics; it demands
consideration of test design appropriate to the intended end-user; and it involves
significant ingenuity in the actual processing of ever-changing technologies—such
as those for microelectromechnical systems described in this issue's article
by Jay Sasserath and David Fries.
IVD manufacturers
are, of course, finely attuned to the difficult challenges involved in refining
a clinical marker for eventual launch as a commercial test. Engaged in such
pursuits on a daily basis, however, they may not often find time to reflect
on the benefits that their work is bringing to the healthcare system. Put finally,
the work of IVD manufacturers is too important to be taken for granted.
Copyright ©2002 IVD Technology
