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23andMe returns with modified, FDA-approved genetic tests

Genetics company 23andMe announced Wednesday that it can again market its health reports based on personal DNA tests, nearly two years after the Food and Drug Administration barred such activity.

Now with the FDA backing, the company has relaunched some of its DNA test kits, which enable consumers to determine their risk of passing certain diseases, like cystic fibrosis, Tay-Sachs Disease or sickle cell anemia. But their prospective list of ‘screenable’ conditions is now restricted to 36 diseases, an 85 percent reduction in screening coverage compared to the past services.

On its revamped website, the service, once priced at $99 a kit, has risen to $199 and promises that the results “meet FDA standards for being clinically and scientifically valid.” This health information is gleaned from a person’s saliva sample. Users would order the kit online. Once it arrived, users spit into a test tube, mail the saliva sample back and receive results by email six to eight weeks later.

Before it’s dispute with FDA, 23andMe favored a direct-to-consumer model that provided raw genetic info to consumers without the guidance of doctors and health counselors to interpret the results. That approach worried the FDA who raised concerns over the test results, if they were incorrect or misinterpreted by consumers. In November 2013, the FDA ruled that the company’s Personal Genome Service required regulatory approval. In its warning letter to 23andMe, the FDA said it was “concerned about the public health consequences of inaccurate results from the P.G.S. device.”

A false positive or false negative could lead a consumer to incorrectly assess a risk that may or may not exist, the FDA said. Depending on the service’s assessment, this could lead someone to “self-manage their treatments” with an incorrect dosage, or delay a necessary treatment for an actual risk.

The FDA also said the company repeatedly failed to address its concerns over its service that could mitigate the risks involved. 23andMe told the Associated Press that the company has since submitted studies to the FDA that showed consumers could understand their tests results.

“Today we’ve successfully established a framework for working with the FDA to bring back reports directly to the consumer,” CEO Anne Wojcicki told the AP. “And we’ll continue to work to try and bring all of this information back.”

Now, the kits include a “carrier status test” that determines what genetic mutations a parent could potentially pass to their children for 36 diseases. The site will continue to offer its ancestry reports as well.

The partial lift of the FDA’s moratorium on 23andMe’s services means the company can no longer offer more than 250 risk reports that were a part of its original kit, AP reported.

To date, more than a million people have used the saliva test kits. The New York Times reported that many consumers have allowed 23andMe to pass along their genetic info to drug makers like Pfizer and Genentech to help develop treatments.

Correction: This post previously stated that the FDA barred the sale of 23andMe. The company was able to market its ancestry reports and uninterpreted genetic data while it worked with the FDA for the eventual approval.

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