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Genomics Company 23andMe Once Again Selling Some Direct-to-Consumer Genetics Tests

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December 3, 2015

Two years after being told by the U.S. Food and Drug Administration (FDA) to discontinue marketing direct-to-consumer saliva collection kits and personal genomic services, 23andMe, a company based in Mountain View, California, has launched a new genomic service. The company will be charging more for the new service and far fewer reports will be available to consumers, at least for now.

The FDA ordered 23andMe to stop selling tests in 2013 out of concern that customers might not be able to understand test results without the help of a trained health professional and that incorrect information might result in consumers having unnecessary medical procedures. There were also questions and concerns about the methods that were used for testing. The test results, if interpreted incorrectly, had the potential to cause harm.

The company says the new reports it will be providing have been cleared by the FDA and include 35+ carrier status reports for diseases including cystic fibrosis, sickle cell anemia, Bloom syndrome, and hereditary hearing loss but not for many others that they previously reported on, such as Alzheimer disease. Carrier tests don't diagnose diseases but rather let people know if they could pass genetic diseases on to their children, an issue that should be discussed with a health practitioner and possibly a genetic counselor.

"We’ve worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing. We are a better company with a better product as a result of our work with the FDA," said 23andMe co-founder and CEO Anne Wojcicki in a statement. The FDA did not release a statement on the new clearance.

Consumers buy the test online, provide a saliva sample, and send it back to the company, which returns a report with patient-specific information. The new reports will also include some wellness information, such as the possibility of lactose intolerance, as well as ancestry reports.

According to reporting by the Wall Street Journal, Ms. Wojcicki says 23andMe had been conducting focus groups with consumers to help improve customer comprehension of test results but has not given a timetable for when the FDA might clear the company to provide consumer information on carrier risks for additional diseases.

In a statement updated this year, the National Society of Genetic Counselors said that "it believes that people interested in at-home DNA testing (also known as direct-to-consumer, DTC, or online genetic testing) have a right to make an independent, informed decision about whether to pursue this form of testing. [However c]ompanies that offer direct access to genetic testing have a responsibility to offer consumers easy access and/or referrals to appropriate resources and qualified genetics professionals, such as genetic counselors."

The Society also publishes a resource on direct-to-consumer testing called "5 Questions to Ask Before Ordering an At Home DNA Test" on its patient information web page. "There are many things to consider before you have genetic testing," says the Society's web page, "especially if ordering a test online without your doctor. Several companies sell DNA testing directly to the public and the types of testing and services differ. The questions [provided in the resource] apply to DNA tests, also called genetic tests, including health-related and ancestry."

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NOTE: This article is based on research that utilizes the sources cited here as well as the collective experience of the Lab Tests Online Editorial Review Board. This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Any new sources cited will be added to the list and distinguished from the original sources used. To access online sources, copy and paste the URL into your browser.

(October 21, 2015) 23andMe Launches New Customer Experience – Reports Include Carrier Status That Meet FDA Standards, Wellness, Traits, and Ancestry. Available online at http://mediacenter.23andme.com/blog/2015/10/21/new-23andme/. Accessed November 20, 2015.

(October 21, 2015) Winslow, Ron. 23andMe Relaunches Direct-to-Consumer Gene Test. The Wall Street Journal. Available online at http://www.wsj.com/articles/23andme-relaunches-direct-to-consumer-gene-test-1445400097. Accessed November 20, 2015.

(June 19, 2015) National Society of Genetic Counselors. Direct Access to Genetic Testing. Available online at http://nsgc.org/p/bl/et/blogid=47&blogaid=370. Accessed on November 20, 2015.

(February 23, 2015) FDA News Release. FDA permits marketing of first direct-to-consumer genetic carrier test for Bloom syndrome. Available online at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm435003.htm. Accessed November 20, 2015.