Warning Letter Issued To 23andMe
November 26, 2013

FDA Warns 23andMe To Stop Selling $99 Genetic Test Kit

Brett Smith for redOrbit.com - Your Universe Online

On Friday, the Food and Drug Administration (FDA) issued a warning to the Google-backed DNA analysis company 23andMe regarding the sales of the company’s Saliva Collection Kit and Personal Genome Service (PGS). The FDA said the products have not undergone the necessary regulatory review.

Founded in 2006 by Anne Wojcicki, the recently separated wife of Google co-founder Sergy Brin, 23andMe offers a DNA test kit for $99 that can be used to identify an array of genetic mutations and offer information about a person's gene-related health risks.

In its warning letter, the FDA said because the product “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,” it falls under a certain regulatory purview that has yet to be met.

In a statement, the Mountain View, California-based company said "we recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission."

In its letter, the FDA noted that certain test results, like a false positive for ovarian cancer, could have potentially disastrous results. Conversely, a false negative for ovarian cancer could provide a false sense of security.

“FDA is concerned about the public health consequences of inaccurate results from the PGS device,” the agency said on Monday according to Bloomberg News. “The main purpose of compliance with FDA’s regulatory requirements is to ensure that the tests work.”

The federal agency did note that 23andMe submitted applications in July and September of 2012 for some disease areas.

"However," the FDA said, "to date your company has failed to address the issues described during previous interactions with the Agency" or furnished requested supplemental information. Subsequently, the FDA said the former applications "are considered withdrawn."

The FDA added that it was "diligently working" to help the company be in compliance and has spent considerable effort evaluating the intended uses of the testing kit, which has included numerous email exchanges, teleconferencing sessions and phone calls.

"However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses," the FDA said.

Earlier this month, Wojcicki told the New York Times that 23andMe had mapped the genotype of nearly 480,000 people over the last five years and she expected to "hit a million" sometime in the first quarter of 2014. She also told Fast Company that her company is aiming for 25 million subscribers.

"Once you get 25 million people, there's just a huge power of what types of discoveries you can make," she said in an interview.

The warning letter means the company will no longer be able to sell its cornerstone product until it falls into compliance.

“Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns,” said Catherine Afarian, a spokeswoman for 23andMe.