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 In its letter, posted on Monday, the agency said it was unable to
identify any FDA clearance for the company's test. The letter
follows 23andMe's limited relaunch last month of a series of
direct-to-consumer (DTC) tests after the agency ordered the tests
off the market.
DNA4Life told Reuters in an earlier interview that it did not
believe it needed FDA approval to sell its test.
DNA4Life, based in Mandeville, Louisiana did not immediately respond
to requests for comment.
In its letter, the FDA said the company's test appears to meet the
definition of a medical device, which requires marketing approval.
The agency said the company needs to provide evidence that the
device has been approved or information regarding why it believes
the test does not require FDA approval.
In a statement sent to Reuters last week, FDA spokesman Eric Pahon
said the FDA believes that "certain types of tests are being
appropriately offered through the DTC model, but others may need to
demonstrate that they are safe and effective and that appropriate
controls are in place to mitigate risks."
The letter comes in the wake of 23andMe's two-year tussle with the
FDA over its direct-to-consumer personal DNA testing service, which
the FDA ordered off the market in 2013.
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Last month, 23andMe relaunched its service with a limited number of
genetic tests for carrier screening - tests that show whether an
individual carries genes associated with 36 different disorders that
could be passed on to a child.
23andMe still does not have FDA approval to resume the sale of tests
that predict drug response.
Experts in pharmacogenetics believe those tests could be much
riskier in the hands of consumers, who might use the information to
make decisions about the drugs they are taking.
(Reporting by Julie Steenhuysen; Editing by W Simon)
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