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Genomic Return of Results Study Underscores Clinical Value, Takeaways for Expanded Implementation

Genomic Return of Results Study Underscores Clinical Value, Takeaways for Expanded Implementation

by Jill Furnival | Feb 9, 2022

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...

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Introducing Research Practices to Boost Study Diversity: Inspiration from the Pandemic

Introducing Research Practices to Boost Study Diversity: Inspiration from the Pandemic

by Jill Furnival | Jan 21, 2022

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...

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The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 2)

The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 2)

by Jill Furnival | Oct 5, 2021

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...

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The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 1)

The FDA 510(k): Bringing a New Genetic Test Directly to Consumers (Part 1)

by Jill Furnival | Jul 29, 2021

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...

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What Led Us to Live Televideo Interviews (LTIs), and Why We Won’t be Turning Back

What Led Us to Live Televideo Interviews (LTIs), and Why We Won’t be Turning Back

by Scott D. Crawford | Jun 1, 2021

This post was written in collaboration with Jesus Arrue Why develop live televideo interview methods? In simpler times, pre-pandemic, we conducted user comprehension and other cognitive interview studies through in-person interviews. We would meet with research...

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The Trouble with UNinformed Consent in Direct-to-Consumer Genetic Testing

The Trouble with UNinformed Consent in Direct-to-Consumer Genetic Testing

by Jill Furnival | May 19, 2021

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...

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Using a Label Comprehension Study for Nonprescription Drug Products

Using a Label Comprehension Study for Nonprescription Drug Products

by Scott D. Crawford | May 12, 2021

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...

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How SoundRocket Helped Ancestry.com Achieve FDA Approval (K192947) with Online User Comprehension Studies

How SoundRocket Helped Ancestry.com Achieve FDA Approval (K192947) with Online User Comprehension Studies

by Gina Chiri-Osmond | Apr 23, 2021

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...

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Ancestry closes DNA Health Business only months after obtaining FDA DTC Approval (K192944) with SoundRocket help

Ancestry closes DNA Health Business only months after obtaining FDA DTC Approval (K192944) with SoundRocket help

by Jill Furnival | Jan 28, 2021

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...

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