FDA To Regulate Complex Diagnostic Tests

The FDA is looking to begin regulation of complex genetic marker tests, known as “multivariate index assays.” Currently these tests are generally the intellectual property of a certain lab, basically the lab’s whole business model. As such, the means by which a result is given are not publicly available, leaving the validity of the algorithm in question. Thus…

Now the F.D.A. is saying it will regulate at least one category of such tests: those that measure multiple genes, proteins or other pieces of clinical information taken from a patient and then use an algorithm or software program to analyze the data. The F.D.A. is calling these tests “multivariate index assays.”
F.D.A. officials said such tests needed regulation because the algorithms used are usually proprietary, making it hard for doctors to interpret the test results.
“It’s important for the agency to look at the data on which these tests are developed,” Dr. Daniel Schultz, the director of the F.D.A. Center for Devices and Radiological Health, said in an interview.
The F.D.A. said it would decide case by case what to do about the tests already on the market. Some might have to come off the market until the developer can provide enough data for approval. However, officials said they would work toward the “least burdensome” approach.
But some test developers and testing laboratories have said that requiring clinical trials and F.D.A. approval would discourage development of tests, which do not usually command the same profits as drugs. They have also argued that the requirement would discourage gradual improvements of tests because each change in a test might require a new regulatory submission.
“I’m not sure we could exist at all if we were required upfront to have F.D.A. approval,” Randy Scott, the chief executive of Genomic Health, said in an interview earlier this year. Mr. Scott was on a plane yesterday and could not be reached for comment.
Even before yesterday, the F.D.A. had been sending letters to certain testing laboratories, including Genomic Health, questioning whether their tests should be regulated. The draft policy issued yesterday has raised speculation that the F.D.A. will eventually move to regulate additional laboratory tests beyond the complex ones.

It’s a tricky situation for the testing labs when the rules change part way through the game. Of course as many are faulting the FDA for being too much in the pocket of industry – taking the “least burdensome” approach and asking each lab if they feel they need to be regulated might not do much to dissuade the criticism.
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