Genetic testing, while available through the medical community for decades, has more recently been available to consumers through a more direct means—the internet. While there are still only a handful of companies offering these services, the competition has been heating up of late, testing costs have dropped dramatically, and the government has stepped in to provide oversight
Original players included 23andMe, Navigenics, and deCode Genetics. Pathway Genomics entered the game in July of 2009, offering genetic results for over 90 disease traits as well as an extensive analysis of an individual’s DNA for risks of diabetes, Alzheimer’s and several other serious diseases along with ancestry tracing, counseling, education and networking. What used to cost thousands of dollars was now available for under $500—in some cases less than $200—without the need for a visit to the doctor.
Pathway had a simple saliva kit that consumers could order through their website, along with a choice of ancestry testing, health marker testing or both. But earlier this year they went one step farther and partnered with CVS/Walgreens to offer the saliva tests on pharmacy shelves across the country. Consumers could pick up the kit and mail it in, paying an additional fee based on the extent to which they wanted their DNA tested.
The over-the-counter version never quite made it to the consumer, as there was public concern over the reliability of the tests and how people might interpret them. At this point the FDA jumped into the fray and expressed concern. Next step was a House panel that was convened to investigate genetic tests, not just from Pathway but also from 23andMe Inc. and Navigenics. While these saliva tests are not FDA-approved, the companies maintain that this was not a necessary step to bringing the product to market.
The FDA has now requested that five companies provide data that their diagnostic tests present scientific evidence that a test result, either positive or negative, is linked to a disease or the risk of one. They also want the companies to seek regulatory approval for the tests, although they stopped short of requiring that the companies pull their tests from the market, at least for now. In fact the letter itself is rather tame, “appreciating a response within 15 days,” but again not “requiring” it.
This looks to be a long-term battle, one in which the consumer may lose out.
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