There is little published guidance on how to present genetic or genomic results in an understandable way and at an appropriate reading level for a typical consumer.1 Most of the literature on developing genetic test reports for non-experts (i.e., anyone without...
Label comprehension studies test how well a typical consumer can understand the labeling for an over-the-counter (i.e., non-prescription) drug or medical device. The labeling may include the product box or the instructions for use found inside the package. The idea is...
What is an FDA user comprehension study? The US Food & Drug Administration (FDA) is responsible for identifying and mitigating consumer risks associated with the products it’s charged to regulate. This includes both prescription products and those sold...
When we looked online at genetic tests marketed to consumers, the options were dizzying; after reading the websites we were left with more questions than answers and we wondered—what does this mean for consumers? - Jill Furnival, Genetic Counselor, SoundRocketNew...
Biobanks studying genes and human health in large populations are popping up around the globe, but what are researchers to do when they uncover medically important—or potentially lifesaving—results for volunteers who gave their DNA anonymously to science? A research...
The pandemic (and virtual technology) brought many things into our homes—work, school, doctor’s appointments, the gym, and conferences (to name a few). And while I’m not eager to attend another virtual cocktail party, there have been some at-home adaptations that have...
So, you’ve developed a genetic test that you’d like to sell directly to the public in the U.S., and you’ve read Part 1 of this two-part series—then you are ready to get some insider tips from a genetic test FDA expert on how to navigate the 510(k) process for your...
So, you’ve developed a genetic test that you’d like to sell directly to the public in the U.S.—from a regulatory perspective, what do you need to know? To start, some genetic tests require U.S. Food & Drug Administration (FDA) review before being marketed...
This post was written in collaboration with Jesus Arrue Why develop live televideo interview methods? In simpler times, pre-pandemic, we conducted user comprehension and other cognitive interview studies through in-person interviews. We would meet with research...