23andMe DNA Spit Kit Lawsuit

Some claim that genetic testing company 23andMe falsely advertised the usefulness and effectiveness of its $99 DNA “spit kit.”

23andMe Class Action: Company Does Not Have Clinical Data to Support Its Medical Claims

Customers who purchased 23andMe’s $99 test received a “spit kit” in the mail so the company could collect a DNA sample. The company claims to perform a genetic test on the saliva, testing for approximately 250 diseases and conditions, and then creates a report stating the diseases and medical conditions that the customer may be at risk of developing.

A class action lawsuit has been filed alleging that 23andMe marketed and sold its Saliva Collection Kit and Personal Genome Service for years without first submitting any analytical or clinical data to the FDA demonstrating the accuracy of the company’s DNA test results. Without this clinical data, the company’s medical reports are meaningless, the lawsuit claims.

The lawsuit also alleges that 23andMe uses the genetic information it collects from customers to create genetic databases and statistical information, which it then sells to other companies.

23andMe Receives FDA Warning Letter

23andMe may have violated the Food, Drug, and Cosmetic Act by selling the spit kit and DNA testing service without first receiving premarket approval or clearance from the Food and Drug Administration (FDA).

FDA rules and regulations require companies that sell medical products and services to submit analytical or clinical evidence demonstrating the safety and effectiveness of the product or service.

Although it had not received FDA approval, 23andMe aggressively advertised its DNA testing service as capable of providing customers with useful and actionable information regarding medical conditions they might be at risk of developing. The company claimed that it’s DNA test can help customers “learn hundreds of things about your health” and that the company will provide “specific health recommendations for you.”

23andMe’s advertising also stated, “Plan for the future. Find out if your children are at risk for inherited conditions, so you can plan for the health of your family.” Upon learning about the company’s DNA testing services, the FDA requested that 23andMe submit clinical data supporting the usefulness and accuracy of the medical results it sends to customers.

Because 23andMe failed to submit the required information, the FDA sent the company a "warning letter" on November 22, 2013, requesting that 23andMe immediately stop marketing and selling the spit kit. In the warning letter, the FDA raised concerns about the public danger involved with providing customers with false positives and false negatives for such serious health conditions as diabetes, coronary heart disease, and breast cancer.

According to the FDA, 23andMe customers might rely on the company’s test results in deciding to stop taking medications or receiving other medical treatments without first consulting a qualified medical professional.