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 The launch is a major step for the company, which in 2013 was
ordered by the Food and Drug Administration to stop selling its
Personal Genome Service because the regulatory agency had not
approved the tests it offered.
The Personal Genome Service, launched in 2007, analyzed a broad menu
of genetic links to disease, including a predisposition to breast
and ovarian cancer, certain heart conditions and Alzheimer's.
23andMe said it is still working with the FDA for approval of those
tests, as well as analyses that can predict a person's response to
specific drugs.
Tests for inherited genetic risks of breast cancer, and drug
response, are already available in other countries such as the
United Kingdom, Canada and Sweden.
"There's more work ahead on the other areas but I'm optimistic,"
23andMe co-founder and Chief Executive Anne Wojcicki said in an
interview.
The new test service, available beginning on Wednesday, will allow
healthy people to see if they carry a genetic variant related to 36
conditions that could be passed on to a child, the company said. The
conditions, apart from cystic fibrosis, include sickle cell anemia,
Tay-Sachs disease and beta thalassemia.
The service also provides non-medical details on traits like
freckles or hair curliness as well as a person's lactose
intolerance.
Priced at $199, the service comes about eight months after U.S.
regulators approved 23andMe's carrier screening test for Bloom's
Syndrome, a disorder that causes short stature and a predisposition
to cancer.
The FDA said at the time that the company could offer carrier
screening tests to customers without seeking regulatory approval
first. 23andMe said it has spent the intervening time, prior to
Wednesday's launch, validating the new tests to make sure they meet
FDA standards.
Carrier tests are generally only done on healthy people considering
having families and are not used to assess an individual’s personal
risk for disease.
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Healthy individuals who are carriers have inherited one normal and
one abnormal variant of a gene associated with a disorder. A child
must inherit two aberrant copies - one from each parent - to develop
symptoms.
The FDA declined to comment ahead of 23andMe's announcement of its
new service. The agency has been strict about direct-to-consumer
genetics tests from other competitors.
23andMe, which is privately held, is backed by Google Inc and was
valued at $1.1 billion in a recent round of venture capital funding.
Like 23andMe, Pathway Genomics also received an FDA warning letter
in 2013, saying that consumers may take medical action on the basis
of its test results without having a full understanding of what they
mean.
Since the FDA rebuke in 2013, 23andMe has focused on gathering
consumer genetic data for use in drug and other research and on
providing customers with reports on their ancestry.
(Reporting by Caroline Humer in New York and Julie Steenhuysen in
Chicago; Editing by Michele Gershberg and Tom Brown)
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