Genetics company 23andMe announced the launch of a new consumer genetic test service on Wednesday that will show whether an individual carries genes associated with 36 different disorders, such as cystic fibrosis.
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.
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.
Source: Reuters Health