Tired Of Waiting On the FDA, 23andMe Moves To the UK

FDA Shuts Down 23andMe’s Genetic Testing Service

23andMe, a US-based personal genome testing provider, will begin marketing its health-related genome assessments in the UK and Canada more than a year after its US operations were shut down by the FDA over allegations that its findings were not always accurate, and for failing to secure pre-market clearance.The company was launched in 2006 by Anne Wojcicki, wife of Google founder Sergey Brin. Since its launch, 23andMe has raised north of $110 million in VC funding, closing a final $50 million round in 2012.

23andMe launched with the goal of providing genetic testing services to the general public. The company developed several products, but its most popular was a health assessment that tested for key genetic mutations and delivered a risk assessment that detailed the customers’ risk of contracting 240 medical conditions, including some very serious diseases, such as Cystic Fibrosis and Sickle Cell Anemia.

The company’s problems with the FDA began in 2009, when the FDA contacted 23andMe asking for verification of both its testing processes, and research backing up its risk interpretations. For the next three years, the company worked with the FDA in hopes of securing some level of regulatory approval, but in 2012, after three years of failed efforts, the FDA shut down 23andMe’s health-related business, leaving it with just its ancestry product and a drastically smaller revenue stream.

Since then, the company’s founder and CEO Anne Wojciki has publically affirmed numerous times that she is still working with the FDA to secure regulatory approval for its genetic testing services. In May 2014, she reported to the San Francisco Chronicle that several trials are underway that should provide the FDA with the data they are requesting. In the same interview, she suggested that efforts were also underway to secure regulatory approval to begin marketing their health-related products abroad.

Six months later, 23andMe has received approval to begin selling its health assessments in both Canada and the UK. The company will begin selling its £125 testing kids immediately. In the meantime, 23andMe is still working with the FDA in hopes of returning to the US. In July, the company submitted testing data to validate its approach for assessing the genetic risk of developing Bloom Syndrome, an inherited disorder that increases a patients risk for cancer, but until then, 23andMe once again has a customer base that it can market its flagship product too.


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