With DNA data becoming more affordable for companies to obtain, the consumer genomics industry is looking set to really gain momentum. Let’s explore the landscape and take a look at what it can do? What are its limitations? and who the key players are. Interpretation of genome data can tell us much about the mutations we carry that can potentially lead to disease. It can also reveal information about our ancestry, nutrition, and family planning. However, there are many points of contention in this area that can be seen through the the FDA’s decision to essentially shut down 23andMe in 2013 for not complying with the FDA required marketing practices. The key principle that the FDA enforced was the requirement for a company to be able to clinically back up any claims that they make in their messaging. This is an incredibly important practice but due to the reality that it requires significant investment in clinical trials to achieve this, the barriers to entry can be quite high for new startups trying to enter the space. Moreover, genetic data is very complex, not very well understood, and difficult to interpret which adds further difficulty when trying to validate claims of effectiveness. Nonetheless, sequencing methods are constantly improving and the potential for these services in preventative medicine is huge. The main players in consumer genomics are:
23andMe is the pioneer in consumer genomics. It is the only direct to consumer genomics company, all the others require a physician interface. For $149, 23andMe customers send a saliva sample and are given information about their health, ancestry and potential disease risks. Founded in 2007 the company has raised $240M to date and has over 1 million customers worldwide.
Helix has created the first "app store” for genetic information. Consumers get their DNA sequenced once and then can receive very specific results via apps as they become available. Helix have just partnered with Mount Sinai, and the National Geographic to bring DNA-powered insights to everyday products and experiences. They also managed to raise $100M investment last year.
Genos wants to pay consumers for their DNA data. The company is using next generation sequencing for consumers and enables them to license their personal data to pharmaceutical and biotech companies for a small fee.