FDA approves 23andMe’s genetic screening test for rare disorder

February 20, 2015 By MassDevice

(Reuters) – Google (NSDQ:GOOG)-backed 23andMe won
U.S. approval on Thursday to market the first direct-to-consumer
genetic test for a mutation that can cause children to inherit
Bloom syndrome, a rare disorder that leads to short height, an
increased risk of cancer and unusual facial features.

The Food and Drug Administration said it plans to issue a
notice to exempt this and other carrier screening tests from the
need to win FDA review before being sold. There will be a 30-day
period for public comment.

“This action creates the least burdensome regulatory path
for autosomal recessive carrier screening tests with similar
uses to enter the market,” the agency said in a statement,
referring to genetic mutations carried by two unaffected
parents.

The FDA previously barred Mountain View, California-based
23andMe from marketing a saliva collection kit and personal
genome service designed to identify a range of health risks
including cancer and heart disease, saying it had not received
marketing clearance.
The current approval is for a much narrower slice of the
genetic testing market.

“The FDA believes that in many circumstances it is not
necessary for consumers to go through a licensed practitioner to
have direct access to their personal genetic information,”
Alberto Gutierrez, director of the FDA’s office of in vitro
diagnostics and radiological health said in a statement.
“These tests have the potential to provide people with
information about possible mutations in their genes that could
be passed on to their children,” he added.

The company conducted two studies to show that the test is
accurate in detecting Bloom syndrome carrier status, the agency
said. The test is intended for post-natal carrier screening in
adults.

“No test is perfect,” the FDA said. “Given the probability
of erroneous results and the rarity of these mutations,
professional societies typically recommend that only prospective
parents with a family history of a genetic disorder undergo
carrier screening.”

Company co-founder Anne Wojcicki said in an interview that
23andMe has not yet decided how much the test will cost or
exactly when it will be available though she expects it will be
“some time this year.”
She said the company has 40 more screening tests of this
type that it hopes gradually to introduce.

The company has not given up hope that it can win FDA
approval for other types of genetic tests for which the agency
currently requires premarket approval, she said.

“This is the first step in what we hope will continue to be
an evolving journey, she said.

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