Learn about the FDA’s new regulatory changes for Laboratory Developed Tests (LDTs) and how they impact premarket review and authorization. Explore key takeaways and implications for healthcare providers and innovators
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...
Laboratory-developed tests, or LDTs, are in vitro diagnostic (IVD) tests designed and conducted in a single laboratory and ordered by a licensed practitioner. By definition, LDTs are not commercially manufactured, marketed, or sold in volume. They are essential to...
In medicine, we have been discussing the promise of polygenic risk scores for some time now. Polygenic risk scores determine whether a person's risk for a common condition, like coronary artery disease or depression, is higher or lower than others. The hope is to use...
Demographic questions are often necessary to include in survey research. Here we visit the age-old question–where in the survey should they go? Recently a collaborator designing a survey for an academic research study asked if it...
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...
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...