Mya Thomae, Founder, CEO, MyraqaBio and Contact Info
Listen (3:10) This letter more specific than in the past
Listen (2:51) What did 23andMe file with the FDA in 2012?
Listen (4:57) Are genetic tests medical devices?
Listen (4:36) Going the regulatory route good for business and patients
Listen (6:02) What about freedom of information?
Listen (1:53) How are 23andMe results different from risk assessments using standard epidemiology?
Listen (5:34) Does the letter signal a more assertive FDA?
Listen (1:05) Why has 23andMe not stopped selling the product?
On Monday, November 25th, the FDA sent a letter to the direct-to-consumer genetic testing company, 23andMe. The letter has received a bit more attention than the average FDA correspondence. The letter was addressed to 23andMe CEO, Anne Wojcicki, and told her that the company’s Personal Genome Service was in violation of the Federal Food, Drug and Cosmetic Act. The FDA requested that the company “immediately discontinue marketing” the test until it receives authorization.
Since the letter came out, there has been much discussion in the life science industry and with the public at large. Some say the letter reveals an over reaching, paternalistic government agency trying to hold back the inevitable, while others see the opportunity for a turning point for a diagnostics industry.
Mya Thomae has been helping companies comply with FDA regulations for 20 years. Mya is intimate with how the FDA works and laments that the diagnostics industry, as opposed to the regulated therapeutics industry, has been on a "race to the bottom." She doesn't hesitate when asked whether the 23andMe test is a medical device.
"Genetic tests are certainly medical devices, and there's numerous examples of different types of genetic tests moving their way through FDA," she says.
The problem with 23andMe, Mya asserts, is that they "haven't done the hard core clinical trials to show that their algorithms do indeed work as they say." And she finds it unfair that 23andMe can keep selling their tests while at the same time some companies are doing the trials, are working with the FDA, and are putting in the time and effort to develop quality tests.
Speaking of the 23andMe website, Mya points out hat the results are constantly changing based on the latest research paper that has just come out.
"Some folks have referred to it as results roulette," she says.
Should 23andMe be treated different from her clients who are pursuing regulation?
"I think 23andMe is different, but I think it's different in the way that makes it a research project as opposed to a product that should be giving clinical results to patients," she says.
What about our right to obtain our own genetic information? And how are the 23andMe results different from checking your risk factor for heart disease against the Framingham studies at the NIH website?
Mya addresses these and other concerns which have risen in the media since the letter was published. She also explains that regulation will be good for business as well as patients.
Is the letter any different from previous FDA letters, and does it signal a more assertive FDA when it comes to LDTs? Mya says she's lost some bets already on when the FDA will regulate LDTs, but she does see a shift happening. At the end of the interview she refers to some final guidance the FDA issued on RUO (research use only) kits the same day the letter to 23andMe was posted. RUO kits and reagents are not allowed for use with diagnostic tests that are approved by the FDA.
We end with the question, why hasn't 23andMe stopped selling the product?
Editor's Note: On Dec 5, 2013 23andMe discontinued selling any health related reports in compliance with the FDA's request.
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