Originally Published IVD Technology November/December 2003
EDITOR'S PAGE
It's just a matter of time
For several years, the IVD industry has been anticipating the day when molecular diagnostics would completely revolutionize the entire practice of clinical diagnostics. While IVD companies have worked hard to commercialize their molecular diagnostics, many obstacles still need to be overcome in order to get them to market.
A recent episode demonstrates that cost remains one of the major barriers to the adoption of some molecular diagnostics. Exact Sciences Corp. (Marlborough, MA) developed a colorectal cancer screening test that is priced about 10 to 20 times more than fecal occult blood tests (FOBT). Although data from a recent multicenter study showed that the Exact test is more sensitive than FOBT, the study authors concluded that the test was arguably not good enough to replace the need for colonoscopy. This conclusion challenged and called into question the reasoning that Exact used in pricing its test. And the market agreed: analyst reaction to the study results was resoundingly negative, and Exact's stock price dropped dramatically by nearly 25%.
Despite such barriers, the IVD industry has not given up on the potential of molecular technologies, and a number of companies have demonstrated that they are fully committed to this area. For example, Roche Molecular Systems (Pleasanton, CA) recently announced that it is investing $155 million in a new molecular diagnostics manufacturing center. This facility will provide the manufacturing and supply functions for the company's polymerase chain reaction diagnostic kits. And FDA authorities have said that they expect a large number of molecular diagnostic submissions during the next few years as a result of the Human Genome Project.
Clearly, the path toward the development of molecular diagnostics—including the obstacles to commercialization—will continue to be a hot topic of discussion and a source of much debate in the IVD industry. IVD Technology contributes to this discussion in this issue with a couple of articles that explore the challenges in the molecular diagnostics field. Emily Winn-Deen, senior director for genomics business at Roche Molecular Systems, discusses other barriers to using information from genetic tests in her article, "Fulfilling the Promise of Personalized Medicine" (page 16). In addition, Jeffrey Gibbs, a partner in the law firm of Hyman Phelps & McNamara, provides an update on analyte specific reagents in his article, "The Past, Present, and Future of ASRs".
One of these days, molecular technologies may prove decisive enough to revolutionize the practice of clinical diagnostics. But for now, other factors are in the driver's seat. For now, only time will tell.
Copyright ©2003 IVD Technology
