In Pharmacogenetics, Just Do the Experiment
Hoopla and publicity greeted Roche Diagnostics's launch of the first clinical diagnostic test to predict people's reactions to certain common medications based on their genetic make up. The test, for CYP450 mutations, runs on a chip made by Affymetrix and is the first fruit of a $70 million-plus collaboration between the companies. But Roche quickly ran into a problem with the FDA, which is concerned that the test, for several reasons, isn't meeting regulatory requirements.
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Affymetrix can succeed long term if gene expression proves to be a viable method for assaying disease. For now, that core question-the extent to which genotype correlates with phenotype-is as much a matter of philosophy as it is demonstrable fact. But making that determination will take time-and much data. Meanwhile, with its first-mover advantage in technology development and a strong IP portfolio, the company's GeneChip will likely as not be the technology used to answer that question. And in that sense, the GeneChip technology is enabling. Thus, at least for the time being, Affymetrix is well positioned to grow its life sciences markets. And through a recent major deal with Roche, it could become a major player in the nascent but arguably huge market for array-based clinical diagnostics.
The proliferation of non-FDA approved clinical diagnostic tests isn't new. But the extent to which bypassing the FDA has become the norm is striking, particularly for new molecular tests. The non-approved tests appear to have good quality and comparable levels of reimbursement to FDA-approved tests, and are cheaper for laboratories. No one in government or elsewhere is forcing laboratories to use the approved tests once they're available. So, many in the diagnostics industry, especially those involved in emerging technologies, are questioning the value of going through the FDA.
Various government agencies are proposing greater government oversight of genetic testing, with the most controversial recommendation asking the FDA to regulate "home brews," the tests that clinical labs develop in-house for clinical purposes. As implementation plans are hashed out slowly, IVD kit makers and clinical labs see both opportunities and hurdles. Hospital labs are concerned about being overburdened by the new rules, while iVD makers worry that reform would give labs an unfair advantage.