FDA interested in collaborating with personal genomics companies

Pharmacogenomics Reporter (subscription required) describes an intriguing twist in the ongoing struggle between the nascent personal genomics industry and regulatory bodies: apparently the FDA is exploring the possibility of collaborating with consumer genomics providers to track adverse drug reactions:

Lawrence Lesko, director of FDA's Office of Clinical Pharmacology, said the agency has already begun preliminary discussions with some undisclosed personal genomics firms "to evaluate the feasibility" of forging such alliances.

In marketing ancestry and disease-predisposition genetic testing services directly to consumers, personal genomics companies are building large electronic databases of clinical and genomic information that the FDA believes can be useful in tracking adverse drug reactions in a post-marketing setting.

The major advantage of the databases accumulated by personal genomics providers, of course, is that you can immediately look for common genetic variants associated with variation in the risk for any newly identified adverse response:

[Lesko says] "We're exploring the possibility that when you do post-marketing surveillance of drugs, and you have hundreds of thousands of genomes analyzed in your database, what would stop you from going back and surveying" whether customers with certain genetic polymorphisms are on certain drugs and have experienced certain adverse reactions?

Before such a collaboration becomes feasible, two things need to change. Firstly, personal genomics companies need to recruit far larger cohorts of consumers - the article quotes deCODE Genetics' Jeffrey Gulcher saying that such a project would require genotype data from "at least 100,000 patients on high-density arrays". While it's hard to extract hard numbers from the current Big Three providers (23andMe, deCODEme and Navigenics) I understand that current sales are somewhere in the low thousands, so it will take major recruiting drives to hit the patient numbers required.

Secondly, the companies will need to extract extremely accurate and detailed clinical information from their customers. Any genome-wide association study is only as good as the clinical data it's based around, and it's hard to see how the current approaches used by personal genomics companies (mainly voluntary survey questions) will provide either the time resolution or the accuracy required to generate useful genetic associations with adverse drug reactions.

The PGx Reporter article suggests that a more realistic prospect for collaboration may be provided by the free genotyping service offered by the non-profit Coriell Institute for Medical Research, which is looking to recruit 10,000 individuals by the end of next year and 100,000 volunteers in total. A representative from the CIMR notes one of the major advantages of their program compared to those offered by consumer genomics companies: it will include representation from a much broader slice of society.

"We not only need to reach those that could afford thousands of dollars of genetic testing, but also those that are in a very minority population who perhaps don't even have very good health coverage."

The volunteers of lower socioeconomic status recruited by the CIMR - who are highly unlikely to fork out for a commercial genome scan, even at 23andMe's new low low price - may well be enriched for the types of adverse health event that the FDA is interested in, as opposed to the upper-middle-class tech-savvy types targeted by personal genomics companies.

Nonetheless, 23andMe can offer one substantial advantage over CIMR's product: they can make the process of exploring your genome fun and cool, which may well prove important in encouraging customers to keep returning to fill in new surveys and perform additional genetic tests. That's a hard act for a sober outfit like Coriell to follow. Just compare the websites (23andMe, CIMR, screenshots below) - which one would you be most attracted by?