Diagnostic Tests and Kits

As PGt and PGx mature, it is highly likely that gene-based diagnostic tests and kits using genetic markers will significantly influence drug development and regulatory review. These tests and kits will not only be used on patient blood or tissue samples to diagnose diseases when they are present, but will also be able to (1) predict the probability of developing-diseases in the future, (2) identify patients who are most likely to be responders or nonresponders, (3) select the most appropriate dose for a given individual, and (4) select the best drug in a class once a decision is made to institute drug therapy. To date, there are relatively few diagnostic test kits approved by FDA, although in the future this would be desirable. HercepTest (Dako Corporation) and PathVysion Her-2 DNA FISH (Vysis) have been approved by FDA to measure HER 2 activity prior to making a medical decision to administer Herceptin to women in advanced stages of breast cancer, and HIV-1 TruGene Assay (Applied Sciences/Visible Genetics) has been approved to measure HIV resistance and to provide drug treatment options for patients with AIDS. FDA approval of gene-based diagnostics would provide many advantages such as assuring high quality reagents, validated reference standards, standardized assay procedures and protocols, and greater acceptance of these tests by patients and physicians. Interpreting the test results for physicians, by bridging this information to package inserts, is likely to become an important responsibility of clinical pharmacologists in the future.

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