Two years ago, the Food and Drug Administration Authority closed down the highly publicized company 23andMe; preventing it from selling its genetic health analysis tests. The CEO, Anne Wojcicki, then helped the company grow internally and improve its standing with the FDA. But that didn’t happen overnight. Breaking natural ties with Silicon Valley, she did so, with utmost patience and positivity.
Her resolution was rewarded when 23andMe got back in the game 
with 36 Autosomal Recessive Disorder tests approved by the FDA. These genetic tests can analyze the diseases which can be passed down from parental genetics to their children. The internal growth and hard work has put 23andMe back into the spotlight, increasing its market value to $1.1 billion.
It hasn’t been easy for the company on the regulation front either. They had to get the tests approved by the FDA according to their requirement, that customers would be able to comprehend the results accurately. 23andMe have thus, made significant leaps in their web design, to sell health tests that can be comprehended by its customers with ease. The company started its design reformation by bringing in Scott Andreas from Yahoo as the director of design at 23andMe. The basic aim was to make the web interface uncomplicated so that consumers could interpret their test results without any help from a physician or a genetic counselor.
23andMe used the two year reprieve offered by the FDA and instead of toiling away that time, they used it make corrections and improvements to the entire system. The Vice President of products, Brad Kittredge, emphasized the innovative nature of the company. 23andMe is a corollary company. It is inherent to make users understand what they are getting themselves into and explaining something very complex to them on an easy scale.
The design team at 23andMe has managed to trim the website and made it user friendly by using images, videos and repetitive information. They also realized the importance of educational material which the user can study at their own convenience and pace without distractions.
23andMe has also managed to get the FDA’s approval as test messengers for providing ancestry information as well as information about Autosominal Recessive Disorders. The FDA has greatly appreciated the company for providing genome data to the consumers without stifling the research and marketability of direct-to-consumer genetic tests.
The CEO of 23andMe says that the company is willing to work 
within ethical boundaries to produce low risk, safe and effective test procedures in the revolutionary field of genetic testing, which is still new to so many people. Despite the difficult history between the FDA and 23andMe, the awaited approval has been worth the wait. With the introduction of the therapeutic division in the company, 23andMe can enter the advanced stages of drug development.
Anne Wojcicki realized that to get in the good books of the FDA, they needed to learn from their mistakes. To prepare for it, she hired new people, gave a complete makeover to the design and product policies, and employed regulatory masterminds to get the paperwork in order. The technical and communication skill set that the company was lacking were overcome with the help of advisors and health care policy makers.
Despite the shaky history between 23andMe and the FDA, the company is now in the good graces of the FDA. Anne Wojcicki has proved to be an excellent team player and her expertise has managed to get the company back on the radar, being more profitable than ever before.
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