The FDA accused 23andMe of misleading customers with its health-related test results, charging in a strongly worded letter on Nov. 22 that it hadn't proven the reliability of its DNA kits. False negatives or positives might encourage patients to treat themselves for diseases they don't actually have — or to medicate improperly, leading to potentially fatal results, according to the FDA.
With 23andMe's latest announcement, customers who purchased testing kits prior to the FDA's letter will still receive and have access to health-related test results. Those who purchased kits after Nov. 22 will be able to get a refund.
While there's little evidence of a self-treatment epidemic — perhaps because major interventions still generally require a doctor's approval — the FDA nevertheless ordered 23andMe to put the brakes on.
Until the company's kit has been properly classified as a medical device, 23andMe will continue to be regarded skeptically by the FDA. Yet the government has rarely dealt with the kind of health claims that 23andMe makes, meaning that an ordinarily lengthy approval process is likely to become even longer.