The U.S. Food and Drug Administration (FDA) has told 23andMe, a personal genetics company, that it must stop marketing its product because it hasn’t been approved.
In a letter dated Nov. 22, 2013 to 23andMe, the FDA said that the company’s saliva collection kit and personal genome service is being marketed without marketing clearance or approval, which violates the Federal Food, Drug and Cosmetic Act. The FDA ordered 23andMe to stop marketing the test until it’s approved.
Read the warning letter the FDA sent to 23andMe.
The FDA is particularly concerned about some of the assessments 23andMe makes based on the results of the genome testing, including the presence of abnormal BRCA1 and BRCA2 genes. People with an abnormal BRCA1 or BRCA2 gene have a much higher-than-average risk of breast and ovarian cancer. The FDA is concerned about both false positive and false negative results from the 23andMe test.
A false positive result means that the test shows that someone has an abnormal BRCA1 or BRCA2 gene when he or she really doesn’t. A false positive result could lead a woman to have one or both healthy breasts removed or take medicines to reduce what she believes is a much higher-than-average risk of breast cancer when her risk is average. A false negative result means the test shows someone doesn’t have an abnormal BRCA1 or BRCA2 gene when he or she really does. A false negative result could cause some women to underestimate their breast cancer risk and not take steps to reduce that risk.
While 23andMe has submitted several approval applications for indications for its test, the FDA said the company has never given it the additional information the agency requested so the applications were considered to be withdrawn.
On Nov. 25, 2013, 23andMe issued a statement regarding the FDA warning letter on its website: “We have received the warning letter from the Food and Drug Administration. 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.”
Stay tuned to Breastcancer.org’s Research News for the latest information on the 23andMe personal genome service.