Posted in Testing Services by Chris Newmarker on November 25, 2013
The FDA is telling 23andMe to stop marketing its Personal Genomic Service tests.
The FDA’s move is but another sign that the regulator is increasingly concerned about the proliferation of relatively cheap genetic tests on the market—one of the many potentially disruptive medical technologies the FDA is confronting.
The agency in 2010 informed Mountain View, CA-based 23andMe and four other genetic test makers that their products needed federal approval.
Three years later, FDA official Alberto Gutierrez tells 23andMe in a warning letter dated last Friday that it did not work with the agency toward de novo classification and did not provide additional information requested to review a 510(k). The company has not even communicated with the FDA since May, according to Gutierrez.
“Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA,” Gutierrez says.
It has been possible to order a 23andMe saliva collection kit online, mail it back in, and have the DNA from the spit tested for a whole host of factors related to health predisposition and ancestry.
Officials at 23andMe, “recognize that we have not met the FDA's expectations regarding timeline and communication regarding our submission,” according to a statement provided by a company spokeswoman.
“Our relationship with the FDA is extremely important to us, and we are committed to fully engaging with them to address their concerns,” the company says.
Those with futuristic visions for health care have pointed to affordable genetic testing as one of the potential disruptors. It has been possible, for example, to order a 23andMe saliva collection kit online, mail it back in, and have the DNA tested for a whole host of factors related to health predisposition and ancestry.
“A 23andMe genome analysis is now at $99. I had my exome sequenced at $999,” Daniel Kraft, MD, executive director of FutureMed, told MPMN early this year.
“We are essentially at the $1000 genome today and it will be $100 genome in a couple years. How will that affect drugs or devices or the combination of the two?” Kraft said.
23andMe cofounder and CEO Anne Wojcicki was listed as one of “10 People Who Changed the Medtech Industry” in a June article in MPMN’s sister publication MDDI.
The article said: “Through 23andMe, Wojcicki is helping to usher in a new era of healthcare in which patients are empowered, care is personalized, and decisions are driven by big data.”
The FDA’s major worry is that products such as 23andMe might empower patients to make dangerous health decisions based on test results that the FDA has not proved to be reliable.
The agency has been grappling with how to regulate a wide variety of new technologies. It sent an unusual “it has come to our attention” letter in May to another Mountain View-based company, Biosense Technologies, over its iPhone-based urine testing product, the uChek Urine analyzer.
The FDA’s warning letter to 23andMe expresses particular concern over Personal Genomic Service uses related to BRCA gene tests that can predict women’s susceptibility to breast cancer.
“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,” says Gutierrez, who is director of the Office of In vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.
The letter also expresses concerns over assessments for drug responses, which “carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment.”
