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NIH Wants to Hear About Genetic Tests
18 March 2010 2:46 pm
Kathy Hudson has been worrying about the quality of genetic tests for years, and now—after becoming chief of staff to National Institutes of Health Director Francis Collins—she's doing something about it.
More than 1600 genetic tests are on the market, and there aren't enough regulations to ensure that they're scientifically sound. To make things easier on consumers, and help scientists keep track, NIH is launching a new online registry that asks gene testing companies to volunteer information on studies they've conducted on their products. "Finally, there's action," Hudson said in an interview with ScienceInsider.
The Genetic Testing Registry will be run by the National Library of Medicine. A big advantage of this is that information on specific tests can be linked to other library resources, such as images of a DNA variant's location in the genome, or papers published on a particular disease susceptibility marker. The result, Hudson hopes, will "be a wonderfully rich resource for physicians and patients and researchers."
As genetic tests have multiplied, concern has grown that oversight is lacking. That's because many gene tests are considered "laboratory developed tests," which get less scrutiny from the U.S. Food and Drug Administration than those developed as "test kits." Regulations for genetic tests are evolving, and it's sometimes not clear whether a particular test falls into FDA's bailiwick or not.
Hudson once pressed for a mandatory registry, but admits it's not clear whether NIH has the authority to require that companies submit data on their tests. Even without that, she hopes the registry will push the industry as a whole to enhance test quality, because peer pressure might encourage companies to submit to the database.
The NIH plan was discussed last month at a private meeting of NIH institute directors. There, some voiced concerns, including whether running a registry might be "burdensome" for the agency, according to meeting minutes that were released, and be misconstrued as NIH providing "brand endorsement" of the tests listed.
Hudson says that the registry will include a disclaimer that NIH isn't backing the data submitted-much like another registry it currently houses, clinicaltrials.gov. She doubts that hosting this new registry will be much trouble. "It's puny," says Hudson, compared to the vast warehouses of data, such as those in genomics, already managed by the agency.
- Correction: This article originally stated that many genetic tests are considered test kits, and that these get less scrutiny from the U.S. Food and Drug Administration than those developed in a lab. In fact, test kits get more scrutiny, but many genetic tests are considered "laboratory developed tests" and receive less scrutiny before going on the market.