Speaking during the recently concluded SXSW festival in Austin, Texas, 23andMe co-founder Anne Wojcicki reportedly acknowledged that the U.S. Food and Drug Administration’s (FDA’s) action to stop the company from marketing its genetic testing service until it clinically validates the test’s prognostic capability and receives FDA marketing authorization for the device has slowed the number of people signing up for the service. Details about FDA’s warning letter appear in Issue 69 of this Bulletin.
Still, she said that 23andMe has 650,000 people in its database and has been “inundated with requests from academics and foreign partners” for access to the data. Wojcicki said that the company will “figure out the path forward” to secure FDA approval and called for genetics to be used for preventative, personalized medicine that can reduce the costs of a health care system which has an economic incentive to treat rather than prevent health problems. she further stated, “One of the reasons we went direct to [the] consumer is so that you own the data. If your insurance company pays they own it, but if you pay you own your own data, and if you then want to share it that’s your right.” See The Guardian, March 9, 2014.
Meanwhile, the New England Journal of Medicine published a comment titled “23andMe and the FDA,” on March 13, 2014, praising FDA’s action and stating, “Before genomic tests have been validated . . . genomic information can be misleading—or just plain wrong—and could cause more harm than good in health care settings.”The comment noted that sequencing genomes, which is continuing to cost less over time, is “the easy part. The difficult part will be, as it is today, the clinical interpretation of an individual’s genome and the making of useful recommendations to the patient-consumer. Put another way, the heart of this debate is not the cost of the sequencing (or sNP [single-nucleotide polymorphism technology on which 23andMe’s services are based] testing), but rather whether the information produced can be used in ways that improve our health.”