Compliance In Focus

Recently we have reviewed the role of direct-to-consumer genetic testing  within the sphere of personalized medicine.  Personalized medicine can refer to tailoring disease treatment, therapy, or prevention to a particular individual, often utilizing some of the genomic signatures that make each of us unique.  Today we will look at a recent FDA news release which looks at personalized medicine from the perspective of the health care professional in respect to two areas: in vitro diagnostic (IVD) companion devices and laboratory developed tests (LDT).

On August 5th we introduced the notion that there is an overwhelming abundance of information available at the fingertips of the consumer.  In Part One we took a closer look at the role of the FDA in Personalized Genomics and direct-to-consumer genetic tests. Now in Part Two we will take a closer look at the role of the FDA in regulating mobile medical applications.

On August 5, 2014 we introduced that the field of personalized medicine has grown rapidly and has encompassed both the field of genetic testing and mobile health apps.  Today we take a closer look at direct-to-consumer genetic testing.  It took thirteen years for the first draft of the human genome to be completed.  In the eleven years since this monumental accomplishment the field of genomics has grown exponentially.  And the fruits of this growth are multi-faceted: tests for disease association, risk, diagnosis, treatment; the list goes on and on.  However the implications for the results of these tests are far-reaching and have a direct affect on both the individual person and on the greater collective.  In the wake of this rapid development of genomic knowledge and increasingly more powerful computers and equipment capable of processing this information, many companies have formed to provide direct to consumer, relatively low cost personalized genomic information.  And with the creation of these companies, the FDA has taken a closer look at the information being disseminated to the consumer.

The amount of information an individual has at their fingertips can be staggering. This can lead to a great deal of empowerment for the consumer in medical, consumer, and social interactions.  In the medical field, improvements in technology have led to a dramatic decrease in the cost to process and analyze an individual’s DNA which has resulted in an influx of genetic tests and information available to an individual. Furthermore, the prevalence of mobile devices/apps (including mobile health apps) has grown exponentially giving consumers an awe-inducing number of choices at the buffet of instant information. As one would expect, this rapid progression has not come without growing pains.  Both the FDA and the companies creating/providing this information have had to consistently re-evaluate how and if this content falls under the auspices of Federal Regulations.