Monthly Archives: November 2013

Stop selling those DNA tests, FDA tells 23andMe

The Food and Drug Administration has ordered DNA testing company 23andMe to stop marketing its over-the-counter genetic test, saying it’s being sold illegally to diagnose diseases, and with no proof it actually works.

The heavily marketed test includes a kit for sampling saliva, and the company promises to offer specific health advice. “Based on your DNA, we’ll provide specific health recommendations for you,” the company says on its website. “Get personalized recommendations.”

In an unusually scathing letter dated Friday, the FDA says it’s been trying to work with the company to get some sort of evidence that the test can do that with any accuracy.

“The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act,” the agency says in a letter addressed to Ann Wojcicki, CEO of 23andMe.

“Therefore, 23andMe must immediately discontinue marketing the PGS until such time as it receives FDA marketing authorization for the device.”

“We have received the warning letter from the Food and Drug Administration,” California-based 23andMe said in a statement. “We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

The agency says the company is making worrisome promises, including assertions that it can tell people their risk of breast cancer and sensitivity to the blood-thinning drug warfarin.

“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,” FDA says in the letter.

The FDA details just how hard staffers have tried to work with the company to sort out these issues, including more than 14 face-to-face meetings and teleconferences and “hundreds of email exchanges” in which the agency gave the company detailed instruction on what to do.

But the company hasn’t provided any evidence that it has, in fact, tested the accuracy of these various genetic probes. “Thus, months after you submitted your 510(k)s and more than five years after you began marketing, you still had not completed some of the studies and had not even started other studies necessary to support a marketing submission for the PGS. It is now nine months later, and you have yet to provide FDA with any new information about these tests,” it says.

FDA’s been warning gene testing companies since 2010, when it told five of them, including 23andMe, that they needed approval. But 23andMe is currently the only company being told to stop marketing its test.

Experts worry the tests are based on flimsy data. Despite these worries, the tests have received extensive media coverage.

Maggie Fox, NBC News

 

Welcome to the California Genetic Privacy Network!

We stand at a critical time in the development of medicine:  the mapping of the human genome has provided powerful new tools to understand the genetic basis of disease and genetic tests can help diagnose genetic conditions, guide treatment decisions, help predict risk of future disease, inform reproductive decision making, and assist medication selection.  Californians are very enthusiastic about the promise of genetic medicine.  Our ability to fully realize its promise, however, is limited by the legitimate fear of how this powerful information can be abused.

The vast amount of genetic data being generated today and its commercialization, raises serious medical privacy concerns.  Many Californians are afraid that their genetic information will be used against them and are unwilling to participate themselves in medical research or be tested clinically, even when they are at risk for serious disease.  The public simply does not trust insurers, employers and other entities with incentives to improperly acquire and use genetic information.

With genetic testing and genetic information increasingly pervasive in our daily lives, the California Genetic Privacy Network serves as a resource for all Californians about their genetic privacy rights.  The California Genetic Privacy Network serves to empower all Californians in decision making regarding their personal genetic information.