23andMe’s Rocky Start

On November 22nd, 2013, the Food and Drug Administration issued a letter of warning to Ann Wojcicki, CEO of 23andMe, about her company’s direct-to-consumer genomic testing service. In what is perhaps the most widely read warning letter in FDA history, Wojcicki is told that it is too risky for people to have access this kind of information without physician supervision. She is then told to stop offering it.

While some might have accepted defeat, Wojcicki had a different take on it. In an interview with Stanford Professor of Practice, Teena Seelig, she shared her opinion about the FDA’s warning: “[It] was a sign that we were doing something…really different. It was a radical change.”

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Consumer-direct genetic testing was uncharted territory for the company and the FDA intended to explore all the ethical implications before giving approval. In the short term, the company suspended health-related genetics testing to comply with the FDA’s warning and subsequently submitted applications to obtain the appropriate regulatory clearances.

23andMe is a personal genomics and biotechnology company that’s been in operation since 2006. Originally founded by Linda Avey, Paul Cusenza, and Anne Wojcicki, they began offering genetic testing services to the general public in November 2007. While co-founders Avey and Cusenza moved on within a few years, Wojcicki stayed on as CEO and finally received permission from the FDA to offer health screening in the form of carrier status and wellness reports.

As of 2019, 23andMe has genotyped over 5 million people. Customers have the option to give consent for their genetic results to be used in medical research.  In July 2018, 23andMe signed a deal with pharmaceutical giant GlaxoSmithKline to share results from their customer base.

“We all have some disease or health issue that we care about. 23andMe has created a research platform to enable interested customers to participate in research – to not wait for solutions to appear, but for people to come together and make discoveries happen,” Wojcicki wrote in a letter to customers regarding 23andMe’s partnership with the drug company.

Wojcicki contends that the genome is an individual’s “digital representation” of themselves and they should have a say in how that information is used. To further that goal, the company empowers their customers to give consent for information to be used in specific medical research – such as breast cancer, diabetes, or Parkinson’s disease.

But others feel that it doesn’t go far enough. Peter Pitts is the president of the Center for Medicine and Public Interest and he argues that people should be compensated if their DNA information is used in medical research.

“Are they going to offer rebates to people who opt in, so their customers aren’t paying for the privilege of 23andMe working with a for-profit company in a for-profit research project?” Pitts asked in an interview with NBC.

The company did not stop there, however. They launched 23andMe Therapeutics in 2015 with the intention of focusing “novel treatments and cures based on genetic insights from the consented 23andMe community.” They have published 130 research papers since 2010, often in collaboration with other agencies.