UPDATED 13:41 EDT / OCTOBER 23 2015

NEWS

Get this genetic data from the revamped 23andMe, after FDA approval

Genetic testing company 23andMe, Inc. has been given a new lease on life with the Food and Drug Administration’s approval to allow the company to relaunch its DNA direct-to-consumer testing kits.

This follows a two-year ban on services when the FDA mandated the company to immediately cease selling genetic tests and marketing interpretations. The FDA cited concerns that the company’s Saliva Collection Kit and Personal Genome Service might give false positives for certain diseases.

A group of customers who felt 23andMe had misled them filed a class-action suit shortly after the FDA’s 2013 decision. The company had claimed they could interpret people’s odds of getting 254 diseases and conditions, including certain cancers and Alzheimer’s disease. They also made the bold claim of offering steps to ward off heart disease and diabetes. That was a lot to ask from a $99 test without the science to back up its assertions.

After its run-in with the FDA, 23andMe continued offering genetic testing for the sake of tracing ancestry, while revamping its saliva test offerings through much blood, sweat, and tears.

With a flashy new website, 23andMe is now offering a $199 service with is divided into four different categories: ancestry, wellness, traits, and carrier status. Ancestry includes basic genealogical lineage on both maternal and paternal sides. Wellness includes such things as a person’s muscle composition and the ability to digest lactose. The traits category focuses on physical features and fun things like sneeze reflex, taste preferences, and the ability to smell asparagus in urine.

The carrier status report has been dramatically scaled back to include information on 36 diseases. Cystic fibrosis, Tay-Sachs, sickle cell anemia, and hereditary hearing loss are among the conditions included. The company is no longer claiming to help you prevent diseases, but is targeting couples interested in family planning. Rather, it is informing customers of genetic variants, which can potentially be passed down to their children.

With the bad blood between the FDA and 23andMe behind them, company cofounder and CEO, Anne Wojcicki, is hopeful the company’s testing will be able to include some disease risk information in the future.

Photo by Petra B. Fritz 


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