Via @NatureNews, a very interesting article about the fight in the United States over how to best administer genetic testing. The company 23andMe has been selling a 99-dollar service in which your DNA profile reveals your carrier status for a slew of genetic diseases (including cystic fibrosis and Tay-Sachs disease), your expected drug response (e.g. caffeine, heroin, postoperative nausea and vomiting), as well as your risk of developing one of 122 diseases such as Alzheimer’s and hypertension.
The FDA claims that 23andMe did not show that its service was safe and effective. The Nature News article goes on to state the following:
“Long after its 2006 founding, 23andMe maintained that its DNA tests provided general information rather than a medical service. Last year, however, the company reversed that stance, submitting paperwork to the FDA on its genetic tests. But the FDA says that the company still has not provided any studies validating the DNA tests that it markets to consumers, despite “14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications”. The agency, which says 23andMe stopped responding to its entreaties entirely in May, has given the company 15 days to take corrective action before the FDA considers regulatory actions such as “seizure, injunction, and civil money penalties”.”
The whole article can be read here.
The company 23andMe have released a short bit of PR in response to the letter:
“We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”
What do you think? Should these services be offered to the public without a medical intermediary to interpret the results for the consumer? Are these genetic predictions even accurate to begin with? I would invite you to chime in in the comments section below.