June 29, 2012

Europe, a regulatory nightmare for direct-to-consumer genetic testing?

Lawyers seem to like direct-to-consumer (DCT) genetic testing. On the Genomics Law Report blog, which I highly recommend, there were no fewer than 23 entries that mentioned or were relevant to DTC in 2011.

Although my interests rarely overlap with those of lawyers, this is an exception.

DTC genetic testing comes in many forms, such as carrier tests for genetic disease, ancestry tests, and nutrigenomic tests. At first glance it appears that consumers should be able to purchase these tests and gain information about themselves and their genomes in any way they like.

However, many DTC tests have not been validated by medical professionals. This means that in the best case quality cannot be assured, and in the worst case, that they could be bogus. Wrong test results could have a large impact, and therefore most experts call for more regulatory oversight of how and by whom these tests can be provided.

In the United States, although the regulatory position of DTC genetic testing varies between states, there is also relevant federal legislation, such as the Genetic Information Nondiscrimination Act.

Regulation of genetic testing in Europe. Source: Borry et al. 2012, European Journal of Human Genetics

Less so in Europe. In a recent publication in the European Journal of Human Genetics, Pascal Borry and coworkers discuss the regulatory framework in seven European countries.

DTC genetic testing is not an area that is directly legislated by EU. Instead, each country draws up its own laws, and there is hardly any harmonisation between them. The result is that in some countries, such as Belgium or the United Kingdom, there is hardly any regulation of DTC genetic testing, whilst in others, it is strongly regulated - sometimes to the extent that non-medical and non-research genetic testing is explicitly banned.

The result is that European companies providing DTC genetic testing would have a hard time taking advantage of the EU's common market.

Could this be a reason why there are no large European DTC genetic testing companies that I am aware of?

June 22, 2012

New sequencing technologies: Who's next?

There are at least a dozen companies that claim to develop new DNA sequencing technology. How many of them will actually release commercially viable products in the next few years?

Oxford Nanopore Technologies clearly leads the pack and has announced that it will release its sequencing devices later this year.

The company that seems to be second closest in terms of releasing a sequencer is Genia, whose technology is also nanopore-based. It has attracted more than $10m in funding, and is expected to market its technology in 2013.

Companies that have not yet made a public announcement on a potential release date but have attracted substantial investment are Nabsys ($17m funding), GnuBio ($8m funding),  Stratos ($7m funding), and possibly LaserGen ($5m funding).

Companies that are thought to develop sequencing technology but that have attracted less investment, or whose finances are unknown, are Noblegen, Base 4 Innovation, Electron Optica, Halcyon, Lightspeed Genomics, and ZS Genetics. Of these, clear signs of activity only come from Noblegen, with a rumoured 2014 release data, and Base 4, which has recently started a recruitment drive.

Whether Base 4 is actually developing sequencing technology is not entirely clear. Their website only hints at single-molecule detection platforms, whilst at least one third-party website also mentions solid-state DNA sequencing.

If only half of these companies are successful in developing a commercially viable product and join the six companies that are already sell next generation sequencers (Illumina, Life Technologies, Roche, Complete Genomics, Pacific Biosciences, Intelligent BioSystems), it is going to be a crowded marketplace.

The really interesting question will be whether there is demand for that many different technologies. Will they all be able to find their own niche?

June 14, 2012

What are the lessons from the case of DeCODE Genetics?

It has gone quiet around DeCODE Genetics, once a poster child for the commercialisation of genomics. Until around five years ago, the Icelandic company was once one of the hottest firms in the field. Then, in 2009, it made headlines by spectacularly going bust. Nowadays, a company with the same name still exists, but not very much is being said or written about it.

DeCODE was founded in 1996 to find the genetic causes of diseases. Soon it started publishing its results in high-profile papers, and its future looked bright enough for an IPO on the NASDAQ stock exchange in 2000. However, it never made a profit, and after some years DeCode was delisted from the NASDAQ again. A few months after that, in November 2009, it declared bankruptcy.

What went wrong? One examplanation is that DeCODE was a victim of the financial crisis that started in 2008. It did not help that $33m of DeCODE's money was managed by Lehman Brothers, and that the company was headquartered in Iceland, which was particularly hard hit by the crisis.

However, DeCODE had already struggled financially before the crisis. The bigger contributor to DeCODE's downfall was probably that is has turned out harder than expected to monetarise the company’s excellent science. It developed a few drug leads, but the most promising lead was suspended in 2006 due to manufacturing problems.

What is DeCODE currently up to? In January 2010, it was purchased by a consortium that includes Polaris Ventures and ARCH Venture Partners, two investors specialising in the life sciences.

The company now focuses exclusively on research. Their website sporadically announces the discovery of variants linked to disease, often in collaboration with other organisations. One such collaboration is with Pfizer, which seems to provide DeCODE with some income. Other sources of income are grants from the NIH and the European Union.

The morale? First-class science is not enough to make a genomics company successful.


As always, please note that everything I write on this blog is my personal opinion and is not endorsed by the Sanger Institute or the Wellcome Trust. Please also note that I will be away until the 19th of July and cannot answer to your comments until then.

June 7, 2012

How to visualise a biotech cluster?

This now has happened to me once too often: I meet someone at an event, they tell me they work for genomics company such-and-such near Cambridge, and I have to admit that I have never heard of that company before.

Below is my attempt to remedy that.

A map of the Cambridge biotech cluster, specifically for genomics. Click on the picture to enlarge.

If you have any ideas how I could improve the map, please leave a comment below. Please note that I will be travelling until the 19th of June and cannot reply to your comments until then.