NEW YORK/CHICAGO (Reuters) - Consumer genetics testing company 23andMe said on Wednesday it was relaunching its personal DNA testing service with a limited menu of tests that have won the approval of the U.S. Food and Drug Administration.
The announcement is a major step for the company, which in 2013 was ordered by the FDA to stop selling its Personal Genome Service because the regulatory agency had not approved the tests, which the company was offering directly to consumers.
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.
The relaunched service will offer FDA-approved tests that show whether an individual carries genes associated with 36 different disorders, such as cystic fibrosis, that could be passed on to a child.
But Dr. Cecile Janssens, a professor of epidemiology at Emory University in Atlanta, said the company still is not testing for the diseases that raised the most concerns for consumers in the past.
These included tests for predisposition to common diseases such as heart attack, asthma and hip fractures, for which lifestyle factors are often more important, Janssens said.
The company also does not test for high-risk genetic variants such as BRCA1 and BRCA2 for breast and ovarian cancer and APOE for Alzheimer’s, and it does not include pharmacogenetic testing.
23andMe said it is still working with the FDA for approval of those additional tests.
23andMe already offers tests for inherited genetic risks and drug response 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 service, available beginning on Wednesday, will allow healthy people to see if they carry a genetic variant related to 36 hereditary conditions. Apart from cystic fibrosis, they 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 lactose intolerance.
Priced at $199, the service comes about eight months after U.S. regulators approved 23andMe’s carrier screening test for Bloom Syndrome, a disorder that causes short stature and a predisposition to cancer.
With that approval, the FDA said it was reclassifying carrier screening tests of this type as Class II medical devices, and would no longer require premarket approval, which involves clinical trials, the agency said in a statement on Wednesday.
Companies seeking approval for similar tests still need to fulfill other requirements, including providing consumers with information on how to gain access to a board-certified geneticist to provide genetic counseling. Each test must also be backed by peer-reviewed science.
Carrier tests are generally ordered by physicians for healthy people considering having families and are not used to assess an individual’s personal risk for disease.
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.
Still, such tests could be unsettling for those who do not undergo pre-test counseling, said Dr. Brian Zikmund-Fisher of the University of Michigan.
“There is a risk that someone will decide to get tested because they are interested in one disease but end up getting potentially disturbing information about another one, one that they perhaps were less prepared to consider,” he said.
23andMe, which is privately held, received early backing from 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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