Following in the footsteps of the pioneering 23andMe, this year has seen startups set up shop in Japan too. This service category can be said to be defined by low price genetic analysis and the estimation of physical inclinations . The characteristics are roughly as follows.
- In all the genetic information, only the part which makes up a person’s individual differences, the so called SNP (single-nucleotide polymorphisms), is investigated. (5000 to a million places depending on the service).
- That individual genetic difference is then causally linked to various diseases based upon published research (each service undertakes this separately)
- The number of SNP’s and the ways in which those SNP’s are linked to diseases constitute the two main features which distinguish the various services.
23andMe biting off a bit more than they could chew
Last year, 23andMe received a warning from the FDA, reducing one part of their service. What was the reason for their warning?
- Ways of displaying SNP differences were separated into two groups: those which at most indicate a trend, and those which are thought to be the cause of a disease.
- Those indicating a trend are what can generally be thought of as being related to physical constitution, and as such did not overly concern the FDA.
- However, defining the causes of diseases and then pointing those out constitutes medical practice.
- A part of 23andMe’s analysis results fall within this “medical practice” rubric.
Becoming established as a non-medical practice service
It seems that the stare-off between 23andMe and the FDA will continue for some time to come. In Japan. however, it appears that it is becoming established as a service which is classified as non-medical. The Ministry of Economy, Trade and Industry, which oversees the genetic investigation business, has put forward some guidelines on the standards that such services need to meet. With some standards in place this should open up the path for an increased number of participating companies in the area.
DeNA, the new entrant to the market, focused on improving the non-medical side
Recently, DeNA, a large provider of games for mobile phones, announced that it would be entering the market in partnership with Tokyo University. According to the director of DeNA, Tomoko Nanba, their aim is to realize a high quality service based upon rigorous science, trust, detailed information on diseases, and counselling on hereditary risks.
- 23andMe – one million SNP , 254 categories, 99 dollars
- DeNA – 750 thousand SNP, 283 categories, 29800 yen
(Because 23andMe is aimed at the Americans and European market, and DeNA’s at Japan, the two cannot be easily compared. The above is for the sake of drawing a rough comparison. )
As you can see from above, however, when it comes to the number of SNP and the cost involved, 23andMe is by far the superior. 23andMe will be likely seek to seek a technological advantage in the future as well. However, this means that they will eventually end up butting into the wall set in place by the FDA. On the other hand, DeNA’s chosen policy is to carefully stick within the legal confines laid out so far, focusing their energy on improving the quality of the service provided.
- Instead of outsourcing analysis, DeNA plans to ensure the necessary facilities exist within the company, halving the time normally spent on analysis.
- By hiring professionals such as certified genetic counselors and clinical psychologists, they aim to provide extra service options.
For 23andMe the improvement of its analysis and technology is a priority. For DeNA, it is the improvement of the quality of its customer service. 23andMe is not entering the Japanese market, and DeNA has not made any comments about overseas expansion. It would certainly be interesting, however, if open competition between these services ever came to be.
Translated by Daniel Burke