23andMe complies with FDA, rebrands testing kits

23andMe will continue giving customers ancestry reports and raw genetic data, but no health analysis

Following orders by the FDA that it cease selling its product last week, genetic testing company 23andMe has done the only thing it could do: it has rebranded and cut out the offending part of the results.

Instead of discontinuing the product altogether, the company has simply decided to take out the health analysis that used to come when the test was done, it was revealed in a note on the company's homepage.

Instead, for the foreseeable future, the results will now only focus only on the ancestral part of the process, while still giving the raw data, but with no health analysis.

"At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process," the company wrote.

When entering the site, every customer must now click that they agree to the following statement:

"I understand that 23andMe only sells ancestry reports and raw genetic data at this time. I understand 23andMe will not provide health-related reports. However, 23andMe may provide health-related results in the future, dependent upon FDA marketing authorization."

When going to buy the test, 23andMe has rebranded it to completely emphasize the ancestral part of the test, without any mention of how it may affect the user's health.

When the "health" button is now clicked, users get a notice explaining why the health related tests have been shut down.

In the letter sent to 23andMe last week, the FDA stated that 23andMe's Saliva Collection Kit and Personal Genome Service (PGS) is in violation of the Federal Food, Drug and Cosmetic Act, because "it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body."

The real trouble, the FDA said, were the potential health risks that can come from false positives and negatives from the test. They are operating under the belief that 23andMe's genetic analysis might be giving people false information that could lead to people making inaccurate medical decisions, 

"For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist," it said in the letter.

To be sure, the company does not agree with the FDA's assessment, but is complying with it in order to keep on operating while it attempts to comply with with the agency’s regulatory review process.

"We also want to make clear that we stand behind the data we have generated for customers," Anne Wojcicki, co-founder of 23andMe wrote in a blog post. "We decided several years ago to comply with CLIA guidelines to be consistent with other types of laboratory testing and to assure customers about the quality of data. Our testing has shown a greater than 99.9 percent accuracy rate."

Since the FDA letter was sent to 23andMe on November 22nd, any customer who bought a kit after that date will not receive the genetic analysis. Customers who bought them before November 22nd, however, will continue to receive them.

23andMe is offering a full refund to any customer who bought their kit after the date in question.

Despite this setback, the company still says that it believes in its mission, and will continue to fight to be able to send complete reports to its customers.

"You, our customer, have powered an incredibly important crowd-sourced research database that I believe can have a significant impact on the pace of discoveries and cures. We will continue our Parkinson’s, sarcoma, MPN and African American research projects and plan to launch more communities in 2014," said Wojcicki

"23andMe will also continue educational efforts to consumers, physicians and other health providers as we believe genetics will be an increasingly important part of all of our lives."

(Image source: https://paulstamatiou.com)