FDA Asserts Its Authority To Regulate Novel Type of Test [WSJ]
Rules Cover Products Used To Decide on Treatments For Breast, Ovarian Cancer
By ANNA WILDE MATHEWS
September 6, 2006; Page A15
The Food and Drug Administration said it plans to begin regulating an emerging category of gene- and protein-based tests, a step toward clarifying government oversight of genetically based diagnostic testing.
In draft guidelines released yesterday, the agency asserted authority over a specific type of test that uses complicated analysis, often involving computer software, to generate results based on a sampling of multiple genes or proteins taken from a patient.
Such tests, which the FDA formally refers to as in vitro diagnostic multivariate index assays, are already being pitched as promising and pricey new options for guiding medical decisions in such areas as breast cancer.
The agency said it expects most of the tests to require at least some FDA review before going on the market, and some may also need a full regulatory approval before they are marketed, as with new drugs and the most complex and innovative medical devices.
The FDA said that it will determine the level of review using a "risk-based approach." The agency has already sent letters to makers of such tests, including Correlogic Systems Inc. and Genomic Health Inc., raising questions about the regulatory status of their products. A spokeswoman for Correlogic had no immediate comment late yesterday, while Genomic Health officials couldn't be reached for comment.
The guidelines will be a step toward clearing up a gray area of government oversight. Much of the growing laboratory-testing industry isn't under direct FDA authority, and tests are often not reviewed or approved by the agency. Laboratories that meet certain government qualifications are allowed to validate and provide their own testing services, including genetic tests, without FDA intervention.
But when a company develops a test that it sells to doctors or others to perform, that product is typically regulated as a medical device under FDA authority. In the middle are "home brew" tests, in which components of a test are marketed to labs, which put them together and perform the test. Some manufacturers and lab companies have questioned the extent of the agency's authority over the home brews.
The FDA has said it generally has the right to assert oversight over such kits, but the agency said yesterday it was singling out the new tests for a higher level of scrutiny partly because of their complexity, which means that doctors typically can't interpret the results themselves.
Another reason for the move was that the tests are being developed for use in serious conditions such as breast and ovarian cancer, where a wrong diagnosis or treatment decision could have major consequences, FDA officials said. "The novelty of the technology and the potential risks of providing inaccurate information are such that it is important for the FDA to verify the accuracy of these tests," said Daniel Schultz, director of the FDA's medical-device center.
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