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...
From the LaunchPad
Welcome to The Launchpad, SoundRocket’s blog, where we share our insights and musings on the science of doing science (well), #soundscience.
The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 1)
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...
DNA Matchmaking: Move Over, Cupid.
Based on a 2020 survey by dating app Plenty of Fish, 90% of US-based daters feel chemistry, not attractiveness, is the key to a lasting successful relationship. Genetic matchmaking sites that offer DNA testing to predict biological compatibility (i.e.: chemistry) couldn’t agree more.
With Valentine’s Day around the corner, we are taking a peek at these direct-to-consumer (DTC) genetic tests and the science behind DNA–based dating . . .
Personal Genetic Tests: 12,000 Gallons of Drool
When I am asked often what I do for a living – a recent story I get to say is “We watch people spit, and then ask them about their experience.” That usually draws a raised eyebrow, and often silence as the recipient of that nugget decides how to rearrange those words into something that makes more sense. Generally, they don’t get there without help.
Genomes2People Expands Partnership with SoundRocket to Improve Personal Genome Sequencing Outcomes
After about seven years with Soundrocket, the Genomes2People Research Program has re-upped and expanded the partnership with the help of a new NIH grant for its PeopleSeq Consortium study.
SoundRocket Collaboration Leads to Key Publication on Predispositional Genome Sequencing in Healthy Adults
An article just released today in Genome Medical, and available here to download in its entirety, reports on a groundbreaking study of over 650 individuals who have received whole genome sequencing as a predisposition screening tool.
Gathering data for direct-to-consumer personal genomic testing made easier with SoundRocket as data collection partner
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.