FDA over-the-counter device designation for 23andMe Personal Genome Service lifts restrictions on shipping from the state of New York and restrictions in the state of Maryland
Mountain View, Calif. – December 4, 2015 – 23andMe, Inc., the leading personal genetics company, today announced that its service is now completely available to people both in New York and Maryland.
Previously, customers in New York could not ship saliva samples from the state, while state law in Maryland prohibited direct-to-consumer genetic testing all together.
While 23andMe was previously authorized to ship sample collection kits to the state of New York, the company was not able to process saliva samples collected in or mailed from the state of New York due to New York Department of Health regulations designating the 23andMe Personal Genome Service as a test requiring direct physician involvement. In Maryland, state law prohibited residents from buying any direct-to-consumer tests that provided health related information. Those tests had to be ordered by a doctor, according to state law.
But the U.S. Food and Drug Administration recent decision designating 23andMe’s Personal Genome Service as an over-the-counter device lifts restrictions in both of those states.
“We are thrilled that our customers in both New York and Maryland will now be able to explore their own DNA without restrictions,” said 23andMe co-founder and CEO Anne Wojcicki. “Customers in both states can now take full advantage of our newly launched and completely redesigned experience which includes reports that meet FDA standards.”
Residents of both states can now, for $199, join other 23andMe customers by ordering a kit online and shipping the saliva sample back from their home state. Once processed, customers will receive:
- More than 60 health, ancestry, wellness, and personal trait reports
- Carrier status tests which reveal whether or not you may pass genetic variants for certain conditions on to your children; tests include cystic fibrosis, sickle cell anemia and hereditary hearing loss
- Reports on genetic research and new genetic discoveries
- Personalized insights based on analysis of 650,000 genetic variations
- Only service available direct-to-consumer with reports that meet FDA standards
- Tools and features unique to 23andMe, such as segment level data for advanced genetic genealogy research and other patented features
- The chance to find and connect with DNA relatives in a database of more than 1 million customers
- New or updated reports, at no additional cost as part of the PGS, as genetic discoveries are made and as 23andMe clears new reports for our genotyping service through the FDA
The 23andMe Personal Genome Service can be purchased online at www.23andMe.com.
About Carrier Status Tests
[Our tests] can be used to determine carrier status in adults from saliva collected using an FDA-cleared collection device (Oragene DX model OGD.500.001), but cannot determine if you have two copies of the genetic variant. Each test is most relevant for people of certain ethnicities. The tests are not intended to diagnose a disease, or tell you anything about your risk for developing a disease in the future. On their own, carrier status tests are not intended to tell you anything about the health of your fetus, or your newborn child’s risk of developing a particular disease later in life.
23andMe, Inc. is the leading consumer genetics and research company. Founded in 2006, the mission of the company is to help people access, understand and benefit from the human genome. The company was named by TIME as a “Genius Company” in 2018, and featured as Fast Company's #2 Most Innovative Health Company in 2018. 23andMe has millions of customers worldwide, with more than 80 percent of customers consented to participate in research. 23andMe, Inc. is located in Sunnyvale, CA. More information is available at www.23andMe.com.