November 8, 2008

The beginning of a new open biotech era?

TIME recently announced the Best Inventions of 2008 and the first prize went to the Retail DNA Test, which is a $399 saliva collection home-kit that is sent to 23andMe Inc. for analysis. 23andMe, Inc. is a privately-held company founded in April 2006 by Linda Avey and Anne Wojcicki. Its investors include Genentech, Google, and New Enterprise Associates (NEA). Products are shipped to the US, Canada and most countries in Europe. Customers can access their accounts 4-6 weeks subsequent to having submitted their samples to learn more about their individual genomes and the potential susceptibilities that they may have. Over 90 traits and diseases are currently covered by the database and tested for, of which 23 are supported by clinical reports and 68 by research reports.

The intention of the Retail DNA Test seems to be to provide a quick and convenient way of getting tested in the privacy of your home, and protecting the integrity of the genetic information by storing the data in a “secure, encrypted system”. The website states that genes are not your destiny, and being aware of possible susceptibilities and certain inclinations should therefore inspire customers to take more active responsibility for their own health and well-being. Furthermore, easily obtainable specifications of each and everyones’ genomes to an affordable price is certainly a step towards the vision of personalized gene-tailored medicine.

Genetic tests are obviously always connected to a number of ethical concerns. The customer could be surprised to learn that his or her father is not their biological father or that they may be the carrier of a gene which may give them a higher susceptibility to a certain disorder. The question a customer needs to ask themselves before ordering the kit is; Why do I want to know this and how will I use the result? It is a rather simple decision to eat less sugar due to a higher susceptibility to diabetes in comparison to decide whether to tell your 12 year old kid that you have a high-risk profile for Alzheimer’s and that he could be in the risk zone as well. The handling of the genetic information also becomes very problematic in relation to life-insurances, and similar, which from a moral perspective could be seen as fraudulent to sign up for with the incomplete information sharing between the two parties that would result if they were not allowed access to the data. On the other hand, if the information would be transparent for all parties, new problems would arise since certain employers would want to discriminate high-risk profiles due to safety reasons.

It is important for the general public to realize that the DNA test may not test for the same genes that they read about in the daily newspaper to have recently been found since there may not be enough scientific data about these or they could be proprietary and hence too expensive for 23and Me. Some somewhat expected examples of the latter are high-risk mutations in the BRCA1 and BRCA2 genes proven to be involved in breast cancer. Myriad Genetics has built up a business model around these that allows few actors to use them for genetic testing to a high price, which makes it close to impossible for low-price genetic testing tools such as 23andMe to include these to a reasonable price.

Inexpensive genetic tests for home use provides a brand new channel for biotechnology companies which already have a number of genes in their patent portfolio and which are looking for many small revenue streams while maximizing societal benefits by adding value to affordable diagnostic tools. I wonder how these new opportunities to directly add value to the end-user experience will be received by the biotech community where many actors since long have relied on royalty-based licenses to other actors. The tragedy of the anti-commons is often brought up whenever biotech patents are discussed in media, but I wonder if not cheaper genetic tests will be one of the key drivers that could create a market where a number of business models can be constructed around the use of genes rather than restricting access to genetic information. This will certainly require the biotech community to change the often common mindset of denying access and instead focus on opening up their upstream research to standardization efforts and open innovation thinking. It is therefore comforting to see that 23andMe seems to keep an open mindset in true Google spirit, which may not be surprising as Google is one of its founders, in relation to their new statistical methods and technological innovations which are “shared with our colleagues” according to their website. So the 1-million dollar question remains to be answered, is this the beginning of a new biotech era?

Tobias Thornblad

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