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...
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...
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...
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...
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?