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Theranos had sought the same FDA authorization, but voluntarily withdrew its request once regulators called the startup out, this time, on the safety protocols issue.
The company also recently got approval for a new cancer risk test, becoming the first and only direct-to-consumer genetics company to receive FDA authorization to test for cancer risk without a prescription.
In a 22 November warning letter addressed to CEO Anne Wojcicki, FDA demanded that the Mountain View, California-based company stop selling its $99 testing kit, which uses a sample of a buyer's saliva to identify genetic variants linked to more than 240 "health conditions and traits," until it receives FDA authorization.
"Being the first and only direct-to-consumer genetics company to receive FDA authorization to test for cancer risk without a prescription is a major milestone for 23andMe and for the consumer," the company's CEO Anne Wojcicki said in a release tied to the announcement.
For example, Uber is currently warring with dozens of taxi and transportation commissions across the globe; Zenefits had to face shutdown threats in Utah; and 23andMe recently earned FDA authorization for performing genetic tests for Bloom Syndrome after several years of being outright prohibited from offering genetic health analysis.
We don't need FDA authorization to start shopping accordingly- today.
Similar(52)
Amifostine is the only FDA-approved radioprotective agent for human use; the authorization is for a few defined and limited, clinical indications.
AVA is not FDA-approved for PEP and could be made available under an Investigational New Drug protocol or an Emergency Use Authorization in a declared emergency.
But they have official authorization.
Acting without official authorization, Maj.
(1) Specific statutory authorization.
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