The FDA has ordered 23andMe to stop sales of their home DNA test kits within two weeks, due to the company's failure to provide proof of the product's scientific validity. After more than five years of marketing and several months after submitting 501(k) requests for FDA clearance, 23andMe has still not provided the information demanded by the FDA to authorize marketing the testing kits to consumers. Google spent large sums of money backing 23andMe in the past.
After a long battle to nail down 23andMe's scientific claims, the FDA is clearly not happy: "FDA has not received any communication from 23andMe since May," the Administration wrote to 23andMe in a letter posted to the FDA website. "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."
The company 23andMe is one of many commercial genetic testing companies that have hit the market in recent years. Since the successful mapping of the human genome, there has been a small boom in ancestry and personal genetic testing products. 23andMe founder Anne Wojcicki claims that 23andMe has already mapped the genotypes of nearly 500,000 people.
But the FDA letter outlines the FDA's concerns about inaccurate home DNA testing kits misleading consumers with severe results: "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." The FDA also warns of potential false negatives in DNA home testing kits like 23andMe's, which could delay diagnosis and treatment for individuals who believe they are not at risk.
The FDA says: "We still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses," reminding Ms. Wojcicki that "the main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work."
Forbes writer Matthew Herper has spoken out against the company's frivolousness to not respond to FDA. "At a time when Anne Wojcicki, the company's chief executive, was going to be on the cover of FastCompany talking about how 23andMe is revolutionizing health care? And 23andMe thought the FDA was going to, I don't know, not notice?"
Many believe DNA home testing providers like 23andMe help make science feel more accessible. But the FDA and other consumer watchdogs think they have been ethically irresponsible.
What do you think? Is 23andMe being investigated too much or too little?
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