INDUSTRY NEWS
During the three years since the Human Genome Project completed the first map of the human genome, genetic testing and personalized medicine have found many supporters within the IVD industry. The 2005 FDA approvals of novel pharmacogenetic tests such as the AmpliChip CYP450 genotyping assay by Roche Molecular Systems Inc. (Pleasanton, CA) and the Invader UGT101 molecular test by Third Wave Technologies Inc. (Madison, WI) cemented the potential and feasibility of these technologies.
The first few months of 2006 have also seen a handful of notable genetic testing products and research agreements. In February, Genzyme Corp. (Cambridge, MA) introduced a test for monitoring drug resistance in patients who are being treated for chronic myeloid leukemia with the drug Gleevec. The following month, Tm Bioscience Corp. (Toronto, ON, Canada) licensed sepsis biomarkers from Sirius Genomics. In announcing the deal, Tm Bioscience expressed its intention to launch a diagnostic in 2007 that could identify patients who are likely to respond to the most widely used sepsis drugs.
Despite the excitement and publicity that has surrounded genetic testing, only a handful of pharmacogenetic IVDs have actually reached market. While FDA and diagnostics researchers angle to stake out territory in the personalized medicine frontier, both groups are pondering how best to develop and promote new genetic tests in a field that many say has not lived up to its potential.
“It is our impression from the front work lines that the pipeline is brimming with good ideas and good products, but the timeline to market is not clear,” says Steven Gutman, MD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety. “FDA has a flexible regulatory toolbox to use in the premarket review of new cutting-edge diagnostics. We expect the biggest challenge is assembling appropriate science to support new uses, not the review of this science.”
In addition, says Gutman, for these new tests to reach patients, manufacturers will need to continue to address the challenge of obtaining healthcare acceptance and reimbursement. “Companies must gather data to ensure that the value of testing is obvious in order to obtain clinical buy-in and to assure payment by third-party payers. The community as a whole—not just companies—must be sensitive to the needs of the healthcare provider in being educated on the proper use of this cutting-edge new technology,” he says.
For their part, IVD companies and researchers acknowledge the obstacles they face both in developing and validating new tests, and in gaining market acceptance for them. However, some believe that to promote and fully realize the potential of genetic testing, fundamental regulatory changes are needed.
“I think there are some good people at FDA who are very committed to pharmacogenetics. However, the requirements of FDA are very different from the way most researchers have been addressing pharmacogenetics,” says William Figg, PhD, senior investigator at the National Cancer Institute (Bethesda, MD). “Unfortunately, we are often determining if a gene is involved in the disposition of a drug retrospectively, and for us to be successful we need to move to a more prospective model. I think we need to be finding out how the drugs are handled earlier and prospectively incorporating these analyses into clinical trials.”
FDA representatives say that the agency has sought to identify many of these bottlenecks through its Critical Path Initiative, a project unveiled in a 2004 white paper that aims to improve the safety, effectiveness, and time to market of new medical products, while lowering costs. Last year, FDA, along with the University of Arizona and SRI International, formed the nonprofit Critical Path Institute (C-Path) to specifically address these issues. In March of this year, FDA published an initial list of 76 priority research projects that it says will help the agency meet its goal of modernizing the drug development process by 2010. In the report, FDA reiterates the importance of personalized medicine while admitting that “new biomarker development has stalled”—in particular, the work needed to assess the utility of new markers.
“There continues to be a wide variety of exploratory efforts in every nook and corner [of personalized medicine] from cancer to infectious diseases,” says Gutman. “FDA has an interest in pharmacogenetic biomarkers for use in diagnostics and as a powerful tool for drug discovery and helping to make more-informed drug-development choices. The FDA Critical Path Initiative is an important event in the life of the development of the pharmacogenetics market, and the introduction of the C-Path Institute is a corollary breakthrough that should help to energize work in this field.” Adds Gutman: “The science here is tough, but the rewards outweigh the obstacles.”
FDA’s “Critical Path Opportunities List,” along with more information about the Critical Path Initiative, can be accessed through the agency’s Web site at www.fda.gov/oc/initiatives/criticalpath.
