…how our research led to FDA clearance. User Comprehension Study AncestryDNA Factor V Leiden Genetic Health Risk Test Download Now Label Comprehension & Human Factors Studies AncestryDNA Saliva Collection Kit…
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Using a Label Comprehension Study for Nonprescription Drug Products
…data analysis. The document reviews the overall process. Label comprehension studies begin iteratively, using a combination of qualitative research and pilot testing to refine the drug label and tweak the…
Research Wonder: DNA with a bow on it, a gift that may (unexpectedly) ‘keep on giving’
…average consumer understands the important issues at a level equivalent to an A- grade in school (they must score a 90% or greater on user comprehension tests.) These tests measure…
Decoding FDA DTC Policy: Part 3 – The November 1 Warning Shots
…genetic testing for warfarin sensitivity to inform initial drug dosing. The second example described is the October 31, 2018 PGSPR 23andMe authorization. While warfarin sensitivity tests are typically ordered by…
About Us
…problems. Schedule a meeting with Scott Provides strategic support for health-related comprehension studies, including those required for regulatory compliance, such as FDA user comprehension, label comprehension, self-selection, and consumer user…
Helix enters DTC game with broad whole exome sequencing platform
…the company, and comprehension of test materials through user comprehension studies. The Helix Laboratory Platform The Helix Laboratory Platform (HLP) was submitted as a data generation tool only, with no clinical or interpretation…
Human Factors CRO
…User Comprehension Ensuring Users Understand Your Product User comprehension studies evaluate how well typical users understand a direct-to-consumer (DTC) health product’s test report and supporting materials. FDA user comprehension studies…
Gathering data for direct-to-consumer personal genomic testing made easier with SoundRocket as data collection partner
Direct-to-consumer personal genomic testing is a growing trend, and data collection partner SoundRocket (Scott Crawford and the team) helped complete an important research study and article. Collaboration This SoundRocket collaboration…
DNA Matchmaking: Move Over, Cupid.
…matchmaking tests do not require FDA authorization because they are low risk genetic tests, similar to ancestry testing or wellness testing. “In general, direct-to-consumer tests for non-medical, general wellness, or…
Decoding FDA DTC Policy: Part 1 – Pharmacogenetics Are Here!
…and commercial customers since 2000. In recent years, he has been involved in several user comprehension studies implemented to support DTC genetic test submissions to the FDA. Shawn Fayer, M.Sc.,…