Things are looking up for 23andMe. Right off a fresh $115 million cash infusion, the Food and Drug Administration is giving the direct-to-consumer DNA company the green light to include health and carrier traits, along with ancestry reports.
This was not the scenario two years ago when the FDA put a moratorium on 23andMe’s ability to provide any health information associated with its personal genome test.
The FDA, concerned 23andMe might illicit a false positive for certain types of diseases, wrote at the time:
“The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act).
This product is a device within the meaning of section 201(h) of the FD&C Act, 21 U.S.C. 321(h), because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body.”
Some might draw the similarities between Theranos’ current FDA struggle and 23andMe. The blood test startup valued at more than $9 billion and backed by the likes of Henry Kissingerrecently came under fire for questions about the accuracy of its test results and the revelation that its proprietary ‘Edison’ machine currently processed only one of its 240 tests. The startup pulled back under regulatory pressure. For the full article click here
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