Are personal DNA tests ready for public consumption?

Should genetic testing kits be available over the counter – alongside pregnancy tests and the like? This topic has come up for debate in 2010 and Congress and the FDA have increased their scrutiny of whether such kits, which analyze a person’s genetic makeup to determine their risk of developing certain medical conditions, as well as potential drug interactions, should be available to consumers without first meeting regulatory approval.

The debate intensified a few months ago when Walgreen shelved its plans to sell over-the-counter genetic tests made by diagnostics firm Pathway Genomics. The retailer balked on its promotional efforts after the FDA announced that it would be examining whether the tests were being marketed accurately and whether they needed FDA clearance.

Just last week the FDA sent a fresh round of warning letters to genetic test makers including Interleukin, Sequenom, and CyGene Laboratories. The agency also held numerous meetings on the topic, including a congressional hearing where the Government Accountability Office released a report finding that tests from several companies returned significantly conflicting results. The GAO’s conclusions are troublesome as patients could potentially make incorrect medical choices based on inaccurate results, and it begs the question of whether the tests have been perfected enough to be marketed at all.

Currently personal DNA tests are sold over the Internet or through physicians, and Walgreen would have been the first retail outlet to sell such products. Walgreen and the test makers have stated that the testing kits are similar to paternity and pregnancy tests already sold as OTC products and shouldn’t need FDA approval. However, because the results of the genetic tests could lead customers to take medical steps that they may not otherwise have taken, these tests should probably be more rigorously inspected and regulated before entering the direct-to-consumer market.

The FDA’s warnings will require test manufacturers to submit evidence that their tests do not meet the agency’s definition of medical devices, and have prompted firms such as Pathway and Navigenics to withdraw plans to market these tests directly to consumers. The agency has stated that it is working to ensure that any gene testing kits marketed over-the-counter are based on sound science and are not marketed under false or exaggerated medical claims – definitely a good idea from this blogger’s point of view.

~

Photo by Patrick Lentz, used under a Creative Commons license.