FDA releases draft guidelines regulating complex diagnostic tests

Sep 6 2006

FDA on Tuesday released draft guidelines that assert the agency's authority for regulating gene- and protein-based diagnostic tests for conditions such as breast cancer and ovarian cancer, the Wall Street Journal reports.

The tests, known as in vitro diagnostic multivariate index assays, diagnose patients using complex algorithms or computer software that base results on samples of multiple proteins or genes taken from a patient.

According to FDA, regulating such tests is necessary because of the complexity of the programs and algorithms used.

"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," Daniel Schultz, director of FDA's medical-device center, said (Wilde Mathews, Wall Street Journal, 9/6).

"It's important for the agency to look at the data on which these tests are developed," he added (Pollack, New York Times, 9/6).

FDA officials said that most of the tests will require some review from the agency and that some tests might require full regulatory approval before they are marketed.

According to the Journal, FDA will use a "risk-based approach" to determine the level of review for each test (Wall Street Journal, 9/6).

Some experts warn that the new guidelines could raise costs, thus limiting access and discouraging development of new tests, the Times reports.

"We don't want to see innovation and access inhibited," Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University, said, adding, "On the other hand, it's really important to make sure that patients and providers have accurate and reliable tests.

It's a fine balance." FDA said it will decide case by case what level of review will be needed for tests already available, adding that although the agency will work toward the "least burdensome" approach, some tests might be taken off the market (New York Times, 9/6).