Originally Published IVD Technology
November/December 2004
EDITOR'S PAGE
Clearing a market roadblock
AAt the Department of Health and Human Services (HHS), great concern has been
expressed over the significant amount of funding that is supporting discoveries
in medical science and the slow pace at which such discoveries are coming onto
the marketplace. To streamline the commercialization of medical technologies,
earlier this year HHS launched its critical path initiative, and solicited public
comments on strategies to accelerate the development and application of new
medical products.
Industry association AdvaMed (Washington, DC) submitted comments on a variety
of issues that have previously slowed the development of medical devices, including
IVDs. In its comments regarding IVDs, AdvaMed discussed at length its concern
over FDA regulation
of genetic tests.
The primary concern raised by AdvaMed is that genetic tests developed by IVD
manufacturers must go through a lengthy review process before obtaining market
approval. Meanwhile, laboratories continue to offer genetic testing services
using home-brew tests that do not go through a similar FDA approval process.
Such an inconsistency in FDA policy has resulted in IVD manufacturers being
largely shut out of the genetic testing market.
By devoting a significant portion of its comments to genetic tests, AdvaMed
focused on what it believes to be the IVD industry’s greatest roadblock
to bringing new scientific discoveries onto the market. Removing this roadblock
would contribute to the growth of the industry and improve the practice of medicine.
AdvaMed’s proposed solution to this roadblock is to create a new regulatory
category called in vitro analytical tests (see IVD Technology, March
2004). The purpose of such a new category would be to regulate the commercialization
of tests designed to measure specific analytes, without any associated claims
with regard to the clinical utility of such measurements.
Implementing a new regulatory category for in vitro analytical tests would help
to remove the roadblock in the IVD industry by making it more likely that manufacturers
and investors will support the R&D necessary to develop and commercialize
molecular diagnostic tests. Such investment would lead to the rapid development
of innovative molecular diagnostics, which have better sensitivity and specificity
than many of the standard immunoassays being used today.
In turn, the development of such tests will also have strong benefits for the
healthcare system at large, providing an essential basis for the emergence of
personalized medicine. Such a change in the practice of medicine has long been
anticipated, but can hardly be expected without the tools that make it possible
to determine a patient’s genetic makeup and predispositions—including
molecular diagnostics. Clearing the roadblocks to commercializing such tests
would be a big step forward for both industry and patients.
Richard Park
Copyright ©2004 IVD Technology
