Originally Published IVD Technology May 2005
EDITOR'S PAGE
A reality check
The wait is finally over for the IVD industry: FDA has issued its much-anticipated final guidance on pharmacogenomic data submissions (see this issue’s news story, “FDA releases pharmacogenomics guidance”). With the release of this guidance and the launch of its pharmacogenomics Web page, FDA has positioned itself to be ready for impending major changes in the medical field, in particular the prospect of personalized medicine becoming a reality. However, the question remains whether IVD manufacturers and their counterparts in the pharmaceutical industry can work together to develop the necessary technologies for personalized medicine.
It is widely recognized that the greatest potential application for pharmacogenomic testing is in the area of personalized medicine, or theranostics. Such testing will help to identify those patients who are most likely to benefit from particular drugs and those who are susceptible to adverse reactions. After undergoing pharmacogenomic tests, patients could be given the right dosage of the best drug the first time, versus the trial-and-error approach of modern-day medical practice.
FDA’s final guidance should encourage greater cooperation between IVD manufacturers and pharmaceutical companies in codeveloping pharmacogenomic tests that are used in conjunction with specific drugs. While this relationship so far has been tenuous at best, this guidance should enhance increased collaborations. However, before such cooperation emerges, IVD manufacturers must address certain fundamental concerns by drug companies.
Pharmaceutical companies want to develop IVDs that do not present any barriers to the adoption of their therapeutics. Drug companies believe technological obstacles created by diagnostics have to be managed.
For example, when fluorescence in situ hybridization (FISH) was first introduced,
it involved the use of a fluorescence microscope, a tedious procedure for laboratory personnel to perform. Since FISH was initially a low-throughput test that required a fair amount of investment by labs, it was not available in many places. Drug companies cannot have the identification of patient populations depend on such tests that cannot be performed efficiently with little or no restrictions.
Another concern is related to financial matters. There is obviously a problem if an
IVD is too expensive. Requiring the use of expensive tests on every possible patient may prevent certain patients from getting the drugs needed. In addition, expensive tests that identify smaller patient populations pose real barriers to the adoption of therapeutics.
Drug companies want tests that can be brought forward at reasonable prices.
IVD manufacturers should strive to allay these concerns of the pharmaceutical industry. If not, IVD companies may have to wait even longer for the era of personalized medicine to come to fruition.
Copyright ©2005 IVD Technology
