What Are User Comprehension Studies and Why are they Required by the FDA?
Unlike tests that are overseen by health care professionals where a conversation may take place about the meaning of results, direct-to-consumer tests bypass the traditional patient-doctor relationship and deliver results directly to patients (or consumers). A well-known example of a direct-to-consumer test is a pregnancy test that one may purchase at any pharmacy or similar retail store…
While many of us were heading out to dish out candy (or tricks) to local goblins and superheroes this past Halloween, the FDA rounded out their suite of De Novo reclassification orders on DTC genetic testing. The latest announcement adds Personal Genome Service Pharmacogenetic Reports (PGSPR) to the existing regulations for Carrier Screening and Genetic Health Risk (GHR) tests (including a specific case of Genetic Health Risk Report for BRCA1/BRCA2)…
And if you could take a genetic test to determine if you have the gene mutations that could show you have an increased risk of having Alzheimers Disease, would you? As the U.S. FDA has started regulating and approving these tests, SoundRocket asks: are there any potential harms and limitations?
This was the first experience for any researchers to look closely at the impact of personal genetic testing reports – to see how users understood them and made use of the results they provide. Soundrocket was happy to play a role in this important research.
Trying to read and understand the latest FDA release on personal genetic testing (or what they are now calling Genetic Health Assessments)? Wish that they could indent when they use multi-level outlines? We have created a version that may be a bit easier to read and understand…
It seems that every few days, an announcement brings forth a new use for Apple’s ResearchKit. My first reaction was one of excitement, mixed with horror. The excitement stemmed from…