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...
Today we are bombarded with online terms of service, contracts, and privacy policies. Whether we are signing up for Spotify or online fitness classes, clauses of click-through legalese lead to the inevitable checkbox – I have read the details and I agree. ...but it...
Over-the-counter drugs and direct-to-consumer genetic tests need to stand alone: here’s how the FDA ensures label comprehension. At SoundRocket, we have spent some time talking about the #SoundScience that is associated with FDA user comprehension studies. These...
When the pandemic began forcing companies to close their physical doors in March 2020, SoundRocket’s Founder and Chief Vision Officer Scott D. Crawford packed up a few belongings and told employees, “Let’s see how this goes. I’m sure we’ll return in a couple of...
More news in the consumer genomics space came this month when direct-to-consumer genetic testing company Ancestry announced they are discontinuing their AncestryHealth business. This move comes just months after receiving FDA approval for a direct-to-consumer...
Prefer to read all five posts about the recent FDA Pharmacogenetics Test Report activity at once? We have compiled the full week here into this one post…
Over the course of this week, we have covered a variety of related topics that arose from the recent FDA activity around direct-to-consumer (DTC) genetic testing. Because this is so new, much is yet unknown, so the best we can do today is speculate. However, we thought we would wrap up today with a few parting ideas to consider…
The National Society of Genetic Counselor’s position statement on DTC testing from 2015 states that consumers have the right to make an informed decision on DTC genetic testing. As with other DTC tests based on SNP array technology, it is important that companies offering these tests are very clear when discussing their limitations. For instance, the 23andMe Personal Genome Service…