23andMe to only provide ancestry, raw genetics data during FDA review

Genetic testing company 23andMe said Thursday it will still allow consumers to access ancestry-related information and raw genetic data without interpretation while complying with a Food and Drug Administration regulatory review.  

23andMe added in a statement that it will continue with the company's educational projects and research using genetic and phenotypic data in their database.

“We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives,” Anne Wojcicki, co-founder and CEO of 23andMe, said in the press release. “Our goal is to work cooperatively with the FDA to provide that opportunity in a way that clearly demonstrates the benefit to people and the validity of the science that underlies the test.”

23andMe sold $99 genetic testing kits that allowed consumers to send in saliva samples. Laboratories then tested the sample, and the company provided detailed information based on the DNA analysis. This included ancestral origins, what traits the person was likely to have and what diseases they were more prone to developing.

On Nov. 22, the FDA asked 23andMe to stop selling the Saliva Collection Kit and Personal Genome Service. The FDA has restricted the company from providing health-related genetics tests while they are being reviewed.

The company said in marketing materials that the kits could provide reports on 254 diseases and conditions, but the FDA noted that the product was not approved by the government for those purposes. 

The FDA was especially concerned because the results could cause consumers to make difficult, life-changing decisions on high-risk health issues, even though there was a possibility for a false positive or negative test result. The FDA was also troubled by the medication sensitivity tests because customers may be more likely to self-medicate or change their dosage without consulting with a medical professional.

Customers who were provided with health-related results or those who purchased kits before Nov. 22, 2013 will still have access to or will be given health-related results. Those who purchased kids after this date will only get ancestry information and raw genetic data without any form of interpretation. It is possible that they will get health-related results at a later date, pending FDA approval. Customers who bought a kit on or after Nov. 22, 2013 can receive a refund, and will be notified by email about how to go about receiving their money back.

A class action lawsuit was filed in the U.S. district court of California on Dec. 4 claiming that the company falsely marketed their kits, and have not proven that they provide scientifically-accurate results.

In October, critics spoke out about a patent on a product that 23andMe filed, called the Family Traits Inheritor Calculator. The product would allow consumers to send in a saliva to see what genetic traits and diseases their potential offspring could have. The application said that the company was seeking to use the item in fertility clinics. It could mean parents would be able to pick their children based on genetic superiority, what critics called "designer babies."

The company later clarified that while at the time they filed the patent they were considering practical applications in the fertility clinic, they have since decided to go in a different direction.

An article in Scientific American has also raised concerns  that people who submitted their samples to 23andMe sign away their rights to their personal genetic data, allowing the company to share information about consumers’ genomes to other companies. This could potentially lead to more targeted consumer medicine, especially from insurance and pharmaceutical companies that would know a person’s “weaknesses.”
23andMe said it would not sell information without explicit consent from the consumer.



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