By DFK | February 19, 2013 at 06:40 PM EST | 16 comments
We have observed the relative risk (increased or decreased) related to diseases and will soon start the discussion on genetic variation related to drug response. First, however, let's talk about all the components that must work together to make personalized medicine (PM) move forward. As you can see, I have termed these the 'cogs' and 'sprockets'. As with any 'fine-tuned' machine, all of the parts must work together and they all have a critical role to play.
It was the rapid progress made with technology (technology and tools) that has brought personalized medicine closer to clinical implementation. The DNA sequencing technology progress has resulted in the cost of whole-genome sequencing to drop, now, close to the 'magic' value of $1000. There was no single study that made this happen...it was the Human Genome Project (HGP) that was the driving force for the lightning-speed advancement in technology that has moved pharmacogenetic testing into some clinical settings at this time. The technology is just one 'cog' or 'sprocket'. What other components will make the (PM) run like a 'well-oiled' machine?
Regulation: The regulatory agencies must provide guidance that will facilitate PM moving forward, such as supporting co-development of drugs and genetic markers related to drug response.
Insurance coverage and reimbursement: When validated and used appropriately, insurers and government programs must be willing to pay for genetic testing as they would other laboratory tests.
Genetic privacy and legal protections: Just as HIPAA has now been a standard, so has the Genetic Information Nondiscrimination Act (GINA), preventing discrimination by employers and health insurers based on genetic information. There will be broader ethical and legal protections as we move forward.
Medical education: All healthcare providers will need to understand the intricacies of genetics related to drug response. The education must be broad to cover all of the other 'cogs' and 'sprockets'.
Healthcare information technology: With all of the data that is produced by the sequencing technology, the infrastructure must be put in place to move raw genetic data to the user in an end-user format.
These are just some examples for each of the components. Now, let's discuss these different components. Please comment on any of the components you wish to discuss. Offer some ideas, concerns, and insight about these. Let's hear your thoughts!