Anne Wojcicki 23andMe Founder and CEO / Getty
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In our report yesterday Anne Wojcicki’s Start-Up 23AndMe In Dispute With US Food And Drug Administration (FDA) we outlined the contents of a warning letter that the US Food And Drug Administration (FDA) had sent at the end of last week to California genetic testing company 23andMe.
Founded seven years ago, the company today markets online a personal genome service that tests for more than 240 “health conditions and genetic traits” at a cost of just US$99 for the service.
The letter from the FDA pointed out major deficiencies in the company’s progress to date in satisfying the FDA that its products met the Agency’s diagnostic standards.
It also pointed out the serious dangers that could arise if such genetic testing should deliver either false negatives or false positives.
Finally the letter told 23andMe in no uncertain terms to cease marketing its products until they met the FFDA’s standards and gave them 15 business days to do so.
After an initial frankly rather casual response on the company’s web site, 23andMe has now issued a more detailed response on the company’s blog.
In it, this time the company’s founder and CEO Anne Wojcicki is much more contrite, recognizes the need for the company to provide data consumers can trust, and continues, “…We stand behind the data that we return to customers – but we recognize that the FDA needs to be convinced of the quality of our data as well.” It then goes on to promise, “…that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.”
A little late one might think given the company’s apparent insouciance about its regulatory responsibilities in the past, but better late than never and the rap on the knuckles from the FDA has obviously now had an effect.
The bottom line is that there is a potential whole explosion of hi-tech innovations coming down the pike in the field of health care, and the fact is that some of the entities involved, who are not already dedicating resources to satisfying regulatory needs such as bio pharma and many established medical technology companies, may not yet have the mind set to deal with it as it needs to be done.
“There’s an app for that” may work well with drive by navigation for your car without too much foresight, but personal health is simply too serious to fool around with. And, giving people genomic data that might lead to surgeries of possible doubtful need is something not to be taken lightly, as the FDA pointedly noted in their letter, and 23andMe and others in the field must now wrap their heads around this if their businesses are really to move forward with public confidence.
While there are great contributions to be made from these new technologies, the FDA seems to be putting its foot down early, and drawing a line in the sand with 23andMe.
If the company thought they could just continue to ignore the FDA as they have hitherto, or assert it has no jurisdiction in their kind of business this simply isn’t going to happen. Even if legally on firm ground, as the definition of what actually constitutes a medical device may certainly not be entirely well-defined, at the end of the day the PR result would be a disaster for any such firm that tried once the FDA puts its foot down as it has now done.
Anne Wojcicki’s blog concludes by saying, “… we will provide updates as they become available”. Corporate compliance is an updatable phenomenon too it seems, just like software.