Last month, personalized medicine took another big step forward when for the first time, the Food and Drug Administration (FDA) approved direct-to-consumer (DTC) marketing for tests that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, including one for Alzheimer’s (see FDA Approves 23andMe Home Genetic Risk Test For Alzheimer’s, 9 Other Conditions).
We have seen steady progress toward more personalized medicine – using an individual’s genetic profile to guide decisions made in regard to the prevention, diagnosis, and treatment of disease (see Are We Ready For Personalized Medicine For Behavioral Disorders?). What else is happening in this market? Here’s a quick rundown of recent headlines:
- NIMH To Fund Research Advancing PsychENCODE Consortium
- Scientists Have Found The Genes that Underlie Intellectual Disability
- First Clear-Cut Risk Genes For Tourette Syndrome Revealed
- Is Genetic Testing The New Paradigm In Treating Addiction?
- Gene Tests for Opioid Response Gain Ground In Addiction Fight
- DNA Scan Uncovers 18 Genes Newly Associated With Autism
- Genetic Variant Score May Flag Dementia Risk
- Researchers Uncover New Potential Genetic Links To Common Brain Disorder
That said, genetic research and testing isn’t what makes this news – allowing direct-to-consumer marketing definitely is. Companies who deliver this services have had to be very careful about how they advertise so that they don’t promise their products are “health tests” – a lesson that 23andme learned in 2013 when the company had to discontinue its service providing health-related data pending completion of an FDA review (see Personalized Medicine Hits A Bump In The Road). It is the officially standpoint of the FDA that:
Marketing genetic tests directly to consumers can increase the risk of a test because a patient may make a decision that adversely affects their health, such as stopping or changing the dose of a medication or continuing an unhealthy lifestyle, without the intervention of a learned intermediary (see Direct-To-Consumer Genetic Testing And The Consequences To The Public).
From the consumer perspective, however, there is a lot of excitement around the availability of consumer-ordered genetic testing services. We have covered these developments (see Soon, It Will Cost Less To Sequence A Genome Than To Flush A Toilet — And That Will Change Medicine Forever). The global DNA testing market size was valued at $6.2 billion (USD) as recently as 2014 (see DNA Testing/Diagnostics Market Report) and is expected to reach $10.04 billion by 2022 (see DNA Testing Market Size To Reach USD 10.04 Billion By 2022) – some estimates have found that 6.3 million Americans (2%) have participated in some form of genetic testing (see Growth of Molecular Diagnostics and Genetic Testing in the USA, 2008-2011).
The simple lesson is that the possibilities for personalized medicine, informed by more genetic research, will continue to grow – and the implications of FDA approval that allows third-party companies to sell these tests directly to consumers means that there will be consequences for the treatment of mental illnesses and addictive disorders. What that could look like is anyone’s guess, which leads to the obvious strategic question – how do you prepare?
Fully-functional technology – electronic health record systems, consumer-directed consumer portals for individual data aggregation, and standardized health information exchange capabilities – will go a long way as practical preparations for the data that will be made available by personalized medicine (see Personalized Medicine & EHR Evolution). These preparations encompass more than just personal genetic information. There is also the wide range of consumer health information that is available by passive and active digital monitoring apps and devices. And changes to the current diagnostics processes and decision support systems to match consumers with the necessary treatment will be a must to keep up with the new “insights” these tests can provide. For even more on the developments in the personal medicine space, check out these resources in the OPEN MINDS Industry Library:
- Personalized Medicine Gets A Push
- More Genetic Testing Information Means?
- Priorities for Personalized Medicine
- Personalized Medicine – Ready Or Not?
- The End Of Symptomatic Psychiatry?
With preparation for integrating consumer-generated health information into your service workflow, there is an opportunity. Both an opportunity to leverage the analytics to improve health outcomes and reduce unnecessary resource use – and an opportunity to improve the consumer experience with your organization. Both are critical to the competitive advantage needed in the emerging market.
For more on identifying disruptive opportunities and developing strategies for that disruption, join us for a free webinar on September 21 at 1 p.m. Eastern, Forecasting The Future: What’s The Impact Of Health Care Technology For Consumers & The Service Delivery System. This webinar session is an exclusive benefit for OPEN MINDS Circle Elite members. Not an Elite member? Upgrade your organization today!