23andMe CEO Talks About Company Comeback, Embattled Theranos

November 12, 2015
By Alex Keown, BioSpace.com Breaking News Staff

MOUNTAIN VIEW, Calif. – After receiving federal approval for its Personal Genome Service testing, California-based 23andMe Chief Executive Officer Anne Wojcicki told Bloomberg she is wedded to the company for the rest of her life as genetic testing will become the future foundation of healthcare.

In a four minute video interview, Wojcicki talked about the role genetics will play in finding cures for various diseases, such as lupus. She said the idea that genetic testing is going to be the foundation of healthcare in the future is at the core of her being,

“When I think about my success moment, it will be when we have that kind of cure, that came because millions of people came together and shared their data … because of that, we were able to create something,” Wojcicki said.

In October the approved 23andMe’s Personal Genome Service that provides carrier status, wellness, trait and ancestry reports to consumers. The test is available for $199 and will include more than 60 health, ancestry, wellness, and reports, as well as personalized insights based on analysis of 650,000 genetic variations according to a company statement.

The FDA’s approval of 23andMe’s new DNA testing is a turnaround from the trouble the company found itself in two years ago. In 2013 the FDA sent a warning letter to the California-based company, saying it must discontinue marketing its health-related genetic tests. The company was forced to stop selling the kits for medical or diagnostic uses, although they could continue to sell them without offering clinical diagnostics.

The FDA was also critical of a lack of communication between 23andMe and federal regulators during regulatory negotiations.

In the interview with Bloomberg, Wojcicki said the company had to adjust to the issues raised by the FDA and focus on hiring the right people and ensuring greater communication.

In the wake of the troubles, Wojcicki said she never thought about selling the company and was “wedded” to it for the rest of her life.

While she praised the data collection conducted by other companies including Google Inc. and Apple , she told Bloomberg she does not view them as competition because 23andMe is focused on genetics as opposed to fitness or health and wellness.

In addition to her own company, Wojcicki talked about Elizabeth Holmes, the CEO of embattled Theranos. She said Holmes has not had to disclose as much information about her company’s work, because she was not required to, but said the FDA is looking to adopt new guidelines that will force more transparency.

“And fundamentally that will actually change everything. Everyone will have to be more transparent about what they’re doing in and how they’re doing it,” Wojcicki said.

23andMe is now looking at expanding beyond the development of DNA testing and exploring the possibility of developing its own medications. In July, the company raised $79 million to partly fund that effort. Additionally, the funding will likely help the company continue with the development of its new therapeutics division. In March, 23andMe began to delve into the therapeutics market, to create a third pillar behind the company’s personal genetics tests and sales of genetic data to pharmaceutical companies.

To bolster its new therapeutics unit, the company has been making strides by nabbing senior pharma officials from big companies, such as Genentech .

The company has a DNA data collection partnership with Genentech worth up to $50 million. To date, 23andMe has collected data from more than one million customers who submitted their DNA to the company’s databank by using the $99 DNA kits developed by the company.

Additionally, the company has a deal with Pfizer Inc. to enroll more than 10,000 patients with colitis or Crohn’s disease. In May, 23andMe inked another deal with Pfizer to launch the Lupus Research Study. The aim is to enroll 5,000 individuals with systemic lupus erythematosus to better understand the genetics of lupus. The effort is also in collaboration with the Lupus Research Institute.

Some privacy advocates have objected to 23andMe’s selling its DNA database information to pharmaceutical companies. However, the company said more than 80 percent of their customers have chosen to participate in the genetic research deals inked by the company, 23andMe said after announcing its one millionth customer last month.

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