Originally Published IVD Technology January/February 2004
EDITOR'S PAGE
Reflections and projections
Looking back, 2003 was a busy year for the IVD industry, especially on the regulatory front. On one hand, 2003 will be remembered as the year of the European Union's IVD Directive. IVD manufacturers were faced with the daunting task of making sure their products complied with the directive's requirements. By December 7, manufacturers had to meet the requirements (covered in a series of IVD Technology articles published during the year) in order to obtain the CE mark that would permit their products to stay on the European market.
On the other hand, 2003 will also be remembered as the first full year of operation for FDA's Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD). Since being established at the end of 2002 by bringing together various functions at FDA, OIVD has been handling all of the agency's IVD-related duties under one roof. And OIVD director Steven Gutman, MD, has spoken at many industry events about the office's "total product life cycle" approach.
So what's in store for the IVD industry in 2004? Which areas will experience unprecedented progress and produce groundbreaking results?
For nearly a decade, many in the IVD industry have been wondering when the field of molecular diagnostics would begin to produce the massive growth that has long been anticipated. So far, such growth has yet to materialize, either in the number of commercial products or in company revenues. It is difficult to tell whether this year will be any different, but recent developments could provide some impetus for the molecular diagnostics field to begin achieving its full potential.
One such development was FDA's release of a draft guidance on how to submit pharmacogenomic data in connection with drug development and subsequent review processes (see News, p. 14). This guidance encourages drug developers to conduct pharmacogenomic tests during drug development and clarifies how the agency will evaluate the resulting data.
It is hard to predict whether this new guidance will contribute to greater use of molecular diagnostics. However, by performing more pharmacogenomic tests, drug companies may realize the need to develop diagnostics that are used in conjunction with their drug products. FDA's release of the guidance indicates that the agency is preparing for an influx of molecular diagnostics product submissions.
It may not happen in 2004. But when that flood of submissions begins, that year will certainly become known as the year of molecular diagnostics.
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