The Food and Drug Administration (FDA) has ordered 23andMe, the California-based personal genomics laboratory, to stop marketing a direct-to-consumer test intended to provide a glimpse into an individual’s future state of health. In a warning letter issued on Nov. 22, the FDA concluded that 23and-Me’s $99 personal genomics service (PGS) test of a customer’s saliva for a variety of genetic abnormalities is a class III medical device and requires FDA approval. “Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these,” Alberto Gutierrez, director of the FDA’s Office of In Vitro Diagnostics, said in the letter to 23andMe Chief Executive Officer Ann Wojcicki. “For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemo prevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.” The FDA order came just […]
The Food and Drug Administration (FDA) has ordered 23andMe, the California-based personal genomics laboratory, to stop marketing a direct-to-consumer test intended to provide a glimpse into an individual’s future state of health.
In a warning letter issued on Nov. 22, the FDA concluded that 23and-Me’s $99 personal genomics service (PGS) test of a customer’s saliva for a variety of genetic abnormalities is a class III medical device and requires FDA approval.
“Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these,” Alberto Gutierrez, director of the FDA’s Office of In Vitro Diagnostics, said in the letter to 23andMe Chief Executive Officer Ann Wojcicki. “For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemo prevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.”
The FDA order came just 11 days after the New York Times published a profile of the company in which Wojcicki predicted that 23andMe would have genotyped 1 million consumers through its PGS assay by the first quarter of next year. The company had performed about 475,000 genotypes as of earlier this month. Late last year, it had raised $50 million in financing to expand its business operations and research.
23andMe submitted 510(k) forms to the FDA last year notifying that it intended to market its test and that it was already similar to other products already available. However, Gutierrez indicated in his letter that the firm had failed to respond in a timely manner to questions the agency had after the 510(k) was submitted.
“Even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions,” Gutierrez observed. According to the letter, 23andMe says the test can pinpoint 254 specific diseases and conditions. As a result, the FDA considered 23andMe’s current 510(k) to have been withdrawn.
The agency has given 23andMe 15 business days after it received the letter to produce a plan of corrective action, including a timetable for implementation. If it doesn’t respond within this period without explanation, it could be subject to legal injunctions and monetary penalties, among other sanctions.
In a blog entry posted to the 23andMe Web site on Nov. 26, Wojcicki acknowledged the company is “behind schedule with our responses.” However, she also suggested the FDA’s concerns regarding the results it provides consumers are overblown.
“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,” Wojcicki wrote.
The company, whose investors include Google co-founder Sergey Brin, has not provided a timeline as to when it expects to reintroduce the test to consumers, and a spokesperson did not respond to a request seeking comment.
Takeaway: The growth of the personal health component of genomic testing may be slowed by regulatory bumps.
