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Bringing a New Genetic Test Directly to Consumers (Part 1)

When it comes to DTCGTs, non-medical tests, such as ancestry testing, trait testing, and general wellness DNA tests, currently do not require FDA premarket review. According to … See more

Actived: 5 days ago

URL: https://soundrocket.com/fda-510-k-new-genetic-test-dtc/

Decoding FDA DTC Policy: Part 2

WebUser comprehension studies are defined as a special control in all FDA DTC authorization processes. Most recently, in the Genetic Health Risk (GHR) protocol, the …

Category: Health Go Health

Decoding FDA DTC Policy in genetic testing

WebThe latest announcement adds Personal Genome Service Pharmacogenetic Reports (PGSPR) to the existing regulations for Carrier Screening and Genetic Health …

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Helix enters DTC genetic testing game

WebIn the same breath, they also announced they obtained 510 (k) clearance for their new Helix Genetic Health Risk App for Late-onset Alzheimer’s Disease, a direct-to …

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FDA Approval on Ancestry DNA Health Business

WebJust shy of one year after launching their physician-mediated model, in mid-August 2020, Ancestry received an FDA 510 (k) approval for their Factor V Leiden …

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SoundRocket's New Higher Education Research Director

WebSoundRocket recently welcomed Josh Patterson, Ph.D., to its Higher Education research team. “The higher education research space has always been a core …

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Jill Furnival, Author at SoundRocket

WebJill Furnival is a certified genetic counselor and science writer based in Toronto, Canada.

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The LaunchPad Blog

WebIn 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 …

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Label Comprehension Studies for Nonprescription Drug Products

WebAt SoundRocket, we have spent some time talking about the #SoundScience that is associated with FDA user comprehension studies. These studies are designed to …

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Comprehension Testing & Optimization for Health Content

WebHealth Content Optimization Studies. Based on our work in this area, SoundRocket has developed a protocol to evaluate and optimize any health content aimed directly at …

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Pivoting in a Pandemic: Online User Comprehension Studies

Web1. Use technology, but keep the human experience. For user comprehension studies in support of DTC GHR tests the FDA prefers in-person, one-on-one meetings. In …

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Genomics & Society in 2030: Looking into the future

WebOn October 28th, the U.S. National Human Genome Research Institute (NHGRI) released “The Future of Genomics: 10 Bold Predictions,” a video looking at the …

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Direct-to-Consumer Polygenic Risk Scores Move Towards FDA …

WebThe FDA dealt with similar issues when they cracked down on 23andMe ‘s direct-to-consumer testing in 2013. This crackdown resulted in a new FDA regulation for …

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Careers & Jobs

WebOpen Jobs. If you do not see an open position, but you are interested in future opportunities, please send an introductory email with your resume attached to …

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Campus Climate Survey Experts

WebOur History with Campus Climate Surveys When SoundRocket was founded in 2004 as the Survey Sciences Group, LLC, its very first data collection was the University of Michigan …

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Surveying Students: The feasibility of using SMS tech

WebText messages (also known as Short Message Service, or SMS) are more and more becoming the go-to medium of communication. This especially is the case for …

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