Welcome to The Launchpad, SoundRocket’s blog, where we share our insights and musings on the science of doing science (well), #soundscience.
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...
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...
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 . . .
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...
Helix made headlines when they announced authorization from the U.S. Food & Drug Administration (FDA) for a whole exome sequencing platform, called the Helix Laboratory Platform. In the same breath, they also announced they obtained 510(k) clearance for their new...
If you’re looking for a last minute gift for friends or family this holiday season, you may be considering direct-to-consumer (DTC) genetic testing kits. These saliva-based at-home DNA tests (offered by companies like 23andMe and Ancestry.com) are available for quick...