Personalized medicine is touted as the wave of the future, but recent government action points to problems for Americans looking to join the health revolution. Last week, California’s Department of Public Health issued cease-and-desist letters to 13 genetic testing startups, threatening to deny service to consumers curious about their DNA.
“Any laboratory offering genetic tests to California residents must be licensed as a clinical laboratory in California. The tests must be ordered by a licensed physician and validated,” reads a statement on the department’s Web site. 23andMe didn’t require a physician’s note when this author and many others used its service, so it seems the company, along with most of the others, may be in trouble.
Despite this threat, 23andMe this week maintained that it is in compliance with California law and is continuing to operate in the state at this time. However, not all genomics firms are taking such an aggressive stance.
Sciona, which tests genes in order to offer nutritional and fitness advice, also received a cease-and-desist letter. The company’s reaction was to yank its US$299 products off the market in both California and New York, another state that is targeting the industry.
Those attempting to read their own genetic data, not somebody else’s, find it appalling that government would stand in the way. One’s genome contains important personal information that each individual should be able to access, without a doctor acting as gatekeeper. Tests like the ones 23andMe supply not only imply possible futures, but also reveal a lot about one’s past. There is something frighteningly Orwellian about government bureaucrats deciding that individuals are not allowed to view their body’s map without official permission.
It is appropriate, of course, for government agencies to enforce the laws on the books, which is what the California’s Department of Public Health is doing. However, when the old rules are so out of sync with the current health landscape provided by new technology, that calls for new rules. As with anything in the technology industry, the faster things are fixed, the better.
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