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FDA releases genetic test guidance

11 September 2006
Appeared in BioNews 375

The US Food and Drug Administration (FDA) released two sets of draft guidelines relating to some types of diagnostic genetic tests last week. According to Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University, the documents clarify the role of the agency in regulating tests performed by diagnostic laboratories, and constitute 'a radical departure from FDA's heretofore hands-off position with respect to in-house developed tests'.

One set of guidelines relate to 'multivariate index assays' - diagnostic tests that look at both genes and proteins, as well as other clinical information. They include tests for conditions such as breast and ovarian cancer, prostate cancer recurrence, cardiovascular disease and Alzheimer's disease. Although the FDA already regulates diagnostic tests sold to laboratories, hospitals and doctors, it does not currently oversee those developed in-house by individual labs - so-called 'homebrew' tests.

Multivariate index assays are one type of homebrew test, the results of which are combined and analysed using a computer program. The FDA says that these tests need regulation because doctors cannot interpret the results for themselves, and also because of the risk that they could lead to incorrect diagnoses for serious conditions such as cancer. Hudson says that the agency clearly views these types of tests as 'raising new safety and effectiveness issues not raised by other in-house developed laboratory tests'.

The second set of guidelines relate to the growing number of genetic tests that look at several gene mutations or genes simultaneously, and clarifies previous guidance on 'analyte specific reagents' (ASRs) - the 'active' ingredient of a test, in this case the pieces of DNA used to detect a particular gene, or gene variant. Hudson said that a recent survey by the Center showed that 45 per cent of genetic testing laboratories carry out tests that have more than one ASR. The new guidance says that manufacturers may not claim more than one purpose for an ASR when selling it to a lab, and also cannot bundle different reagents together and sell them as a single ASR.

The Center has been campaigning for some time for increased oversight of genetic tests. It says that the vast majority of the 1000 genetic tests available today are developed in-house, so the FDAs' decisions could have 'significant impact' on the quality and availability of genetic tests overall. 'We don't want to see innovation and access inhibited', said Hudson, but 'it's really important to make sure that patients and providers have accurate and reliable tests'.

SOURCES & REFERENCES
Center Sees "New Era in Oversight" of Genetic Tests in Two New FDA Draft Guidances
GPPC |  7 September 2006
FDA Drafts Regulatory Direction to Industry for Active Ingredients Used in Medical Tests
FDA |  5 September 2006
FDA Drafts Regulatory Guidance to Industry and Labs for Group of Medical Tests
FDA |  5 September 2006
FDA To Begin Requiring Approval Before Genetic Tests Can Be Marketed
Kaiser Network |  6 September 2006
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