23andMe, the DNA testing company has been ordered by the Food and Drug Administration to stop its sale of over the counter Personal Genome Service (PGS) kit. It has declared its marketing and sales as illegal and unauthorized as the company has not provided any evidence regarding the efficacy of this generic test.
The test kit includes a saliva sampling kit on the basis of which the company will provide health advice and diagnose the health issues of the person taking the test. On its website the company promises on the basis of the DNA, it will give specific and personalized advice as required.
The Food and Drug Administration has written a letter to the company asking them to provide evidence and proof regarding the test kit. The Personal Genome Service is a violation of the Federal Food, Drug and Cosmetic Act as the company does not have any market clearance or any sort of approval from the FDA. Therefore the company 23andMe will have to discontinue its sale of the Personal Genome Service kit from the market as soon as possible. The letter was sent from the FDA to the company’s CEO Ann Wojcicki.
The California based company 23andMe has acknowledged the FDA’s warning and has apologized for not meeting the FDA’s timeline for submission of their report. It has considered the Food and Drug Administration’s letter as a priority and they will definitely try to resolve this issue. According to the FDA, the company even promises to the people that they can diagnose risk of breast cancer which is a very serious assertion. It is serious because if the report falsely states positive for breast cancer or ovarian cancer, the person can undergo a number of tests like chemoprevention, prophylactic surgery, intensive screening and other related tests. While a false negative, may lead a patient to overlook the risk which might prove to be fatal for the patient.
The FDA has been warning such 5 DNA testing companies including 23andMe since the year 2010; however 23andMe is the first one among them to be told to discontinue the product from the market. But the company has not yet provided any substantial evidence or proof of any kind to the FDA. The FDA had around 14 face to face meetings with the company 23andMe along with teleconferences. It had exchange hundred of emails on what the company is required to do. However after such meetings and exchanges, 23andMe has still not done anything about it.