The major issue the firm faces are legal run-ins with the FDA. Progress made through the FDA and its regulations has allowed 23andMe to stay ahead of its competitors as the FDA can take years to authorize the health benefits associated with DNA testing. It started in 2013 when 23andMe was forced by the FDA to discontinue marketing health-related genetic tests, leaving the firm to provide only ancestry reports and raw data to its customers. Then in 2015, the new FDA compliant genetic service 23andMe was launched, giving the firm a competitive advantage that was impossible to easily imitate. Later years, 23andMe received authorization from the FDA to market genetic health risks reports such as Late-Onset Alzheimer’s Disease. 2018 the firm is the first to provide direct-to-consumer genetic test for cancer risk. Although 23andMe has had some challenges, it continues to be a first mover in its industry.
Another problem that 23andMe will face is the risk of security threats. Even though the firm has a robust security network, it will be a never-ending challenge. For example, the recent data breach of MyHeritage is leaving skeptics of such technology asking if the risks of having your very private information invaded outweigh the benefits of finding out your ancestral descent. Moving forward, all firms who own big data, including 23andMe, will face this technological paradox of how big data is solving major problems today, and keeping up with the pace of the savvy hackers of tomorrow. An article published in summer of last year discussed the scandal involving 23 and Me selling data to drug makers (pharmaceutical giant GlaxosmithKline), in July of 2018 the pharmaceutical company acquired a $300million dollar stake in 23 and Me’s stock. As part of this deal the company would combined GlaxosmithKline and 23 and Me data to look for new drugs to develop, also know a drug targets. This goes to show that often times despite all necessary precautions to ensure the safety and security of data leaks can still occur.