When was 23andme founded

Spit in a vial, send it in, and the company will look at thousands of regions in your DNA that are known to vary from human to human—and which are responsible for some of our traits.

For example a site in your genome named rs can come in three varieties. If you happen to have what is known as the GG variant, there is a good probability that you are unable to smell asparagus in your urine; those blessed with the GA or AG varieties are much more likely to be repulsed by their own pee after having a few spears at Spargelfest.

At first, 23andMe seemed to angle its kit as a fun way to learn a little genetics using yourself as a test subject. Certain regions signal an increased risk of breast cancer, the impending onset of metabolic diseases, and sensitivity to medications. And any kit intended to cure, mitigate, treat, prevent, or diagnose a disease is, according to federal law, a "medical device" that needs to be deemed safe and effective by the FDA. Since mid, 23andMe has been negotiating with the agency, and in July , the company finally began the process of getting clearance from the FDA to sell the kit that it had already been selling for five years.

It apparently blew through its FDA deadlines, effectively annulling the clearance process, and abruptly cut off contact with the agency in May. This left the agency with little alternative but to take action. It is a mechanism meant to be a front end for a massive information-gathering operation against an unwitting public.

Sound paranoid? Consider the case of Google. When it first launched, Google billed itself as a faithful servant of the consumer, a company devoted only to building the best tool to help us satisfy our cravings for information on the web.

Wojcicki founded 23andme in with Linda Avey and Paul Cusenza with a goal of upending conventional models of health care. Wojcicki aimed to attract millions of customers by selling an inexpensive test that would reveal genetic predispositions for dozens of traits. It would provide disease risks, but also genetic propensity for baldness, obesity and trivial features such as earwax consistency.

Wojcicki wanted to make the genome fun and engaging, the better to attract customers. She hosted celebrity 'spit' parties to get the product in the hands of tastemakers and stir up media interest: after taking one of the company's tests, Ivanka Trump gloated that she had a very low genetic risk of becoming obese. As the tests hit the market in late , Wojcicki and Avey were hailed as visionaries Cusenza had left in ; Avey would depart in Scientists, meanwhile, were dubious.

Family history was and is still a more powerful indicator than genes are for predicting the risk of most diseases. There were also questions about 23andme's plan to sell customer data to help develop medicines. Companies have been trying to mine genetic data to design drugs for at least a decade, with little success.

Take deCODE genetics, founded in Reykjavik in , which recruited about half of the adult population of Iceland into a genetic study. Although the company's research has provided insights into the genetic mechanisms of disease, it hasn't yet yielded a drug. In , the FDA started asking 23andme for evidence that the company's products worked as advertised and wouldn't harm customers.

The agency was worried that people might take drastic medical measures on the basis of their test results, such as deciding to change the dosage of their medications without consulting a doctor or undergoing unnecessary surgery, such as a mastectomy, or treatment based on false positives.

Regulators demanded evidence that the tests were accurate, and that customers were well informed what the results meant. The next years were difficult ones for 23andme.

It communicated with the agency on a few occasions and promised in January that data would be forthcoming. According to the FDA, it then ceased communicating with regulators entirely in May, even as it started a new advertising campaign.

Fed up, the agency sent Wojcicki a strongly worded warning letter on 22 November ordering her company to stop marketing its product. It was a self-inflicted wound for the company. As a result, 23andme was forced to drastically cut its customer offerings, threatening its viability.

Wojcicki was stunned. Soon after the letter arrived, Wojcicki called Kathy Hibbs, a lawyer then working for Genomic Health, a gene-testing company in nearby Redwood City, California. And to get there, she counselled, Wojcicki would have to cooperate with regulators. It was a tough adjustment for Wojcicki; she didn't think that the FDA should be able to stop customers from learning their own genetic information. But Hibbs and others convinced her that capitulating to the FDA's demands was the fastest way to rescue her company.

By the end of , Hibbs felt that the company was ready, so she asked the FDA to approve one test, intended to tell customers whether their children might inherit a genetic risk for a disease called Bloom syndrome. The FDA approved the test in February The news didn't make a huge public splash: Bloom syndrome is a very rare disorder, affecting about 1 in 50, people with Ashkenazi Jewish heritage.

But 23andme was now the first company approved to market a direct-to-consumer genetic test for a disease in the United States, although it had already been offering the test overseas.

But even after the FDA's decision this April, 23andme is still barred from giving customers lots of available information, such as whether they carry gene variants that raise their risk for certain cancers or that predict how well certain medications will work. Before the FDA lockdown, it had been providing information on hundreds of health conditions.

Greely says that the restrictions make sense: there is very strong evidence that genetic variants cause the ten conditions listed in the FDA's approval in April. But the predictive value is much weaker for the variants linked to the vast majority of common health conditions that 23andme would like to tell its customers about. Even as the company confronted resistance at the FDA, it was making moves into drug development.

Key to this plan was bringing Scheller aboard. While her sisters gravitated toward art and math, Wojcicki was nerdy but social. Among those to fall for her charms was Brin and much later, baseball player Alex Rodrigue z , whom she met after her oldest sister, Susan, rented out the garage of her Menlo Park home in to two ambitious Ph. The middle Wojcicki sister, Janet, is now a globe-trotting epidemiologist who teaches at the University of California, San Francisco.

Wojcicki first got fired up to battle the healthcare system as a young Yale University graduate working as an analyst at a small firm on Wall Street. The human genome was first sequenced in , and scientists were entranced with what the code could unlock.

Wojcicki got introduced to Linda Avey, who had studied biology as an undergraduate and was creating research programs at Affymetrix, a gene-testing company in Santa Clara, California. The two began brainstorming over dinner in December Google did come through. Customers learned about their ancestry, their likelihood of going bald and their risk for some common health conditions like heart disease.

The company skirted FDA regulations by advertising itself as a fun way for people to get insight into their DNA, rather than as a medical tool. But 23andMe generated reports for much less by using a technology called genotyping, which spot-checks specific parts of a gene for mutations known to be linked to certain diseases, instead of sequencing, which entails reading the entire gene. Anne Wojcicki values individual agency, both in her own life and for her customers.

She wants them to be able to take action from their DNA results. Wojcicki loved being the party planner, but adoption was slow. Competitors like Navigenics died out. By , four years after its launch, 23andMe had amassed only , customers. Wojcicki was ready to go bigger. By October , 23andMe was in talks with Target and Wojcicki was pushing hard to enter stores before the holidays, a move that would have put the testing kit in the aisles alongside vitamins and thermometers.

Bloomberg News reported news of a potential deal last week. A merger with a special purpose acquisition company, or SPAC, allows 23andMe to go public without the uncertainty or holding an initial public offering. Now more than ever, she said, people are interested in preventative health care. The influx of new capital will allow the company to expand its efforts in developing therapeutics from its trove of genetic data, according to Wojcicki.

In the s, Branson founded the Virgin Group that now owns hundreds of companies.