Ann Arbor, MI – February 21, 2025 – SoundRocket, a leader in user comprehension research for regulated medical and diagnostic devices, is proud to announce its role in securing FDA clearance for the GlutenID Celiac Genetic Health Risk (GHR) Test (K241456), developed by Targeted Genomics. The GlutenID test, a direct-to-consumer (DTC) genetic health risk (GHR) assessment that enables individuals and families to better understand their risk for celiac disease based on DNA testing, is Targeted Genomics’ first FDA clearance.
This milestone was achieved in part due to a user comprehension study conducted by SoundRocket, which demonstrated that consumers could accurately interpret their genetic test results without healthcare provider guidance. The study played a critical role in the FDA’s review, confirming that the test met regulatory standards for DTC use.
SoundRocket’s Role in FDA Clearance of the GlutenID Test
For the GlutenID Test, SoundRocket designed and implemented a rigorous user comprehension study, ensuring that consumers could understand the test results, their implications, and appropriate next steps. The study included:
- Expert Review & Readability Testing – Evaluating and optimizing the GlutenID test report, educational materials, and FAQs for clarity and ensuring an 8th-grade reading level, per FDA requirements.
- Iterative Testing & Pilot Studies – Conducting multiple rounds of virtual cognitive interviews to refine the GlutenID test materials and the user comprehension study design.
- FDA User Comprehension Study – A 314-participant study assessing six key comprehension domains, achieving an overall comprehension rate of 95.8%, surpassing the FDA’s 90% threshold, as predefined in the GHR assessment system regulation (21 CFR 866.5950).
These results provided evidence to the FDA that typical consumers could correctly interpret their genetic test results and determine appropriate next steps, paving the way for the clearance of the GlutenID Test for DTC use.
Advancing the Future of Direct-to-Consumer Genetic Testing
“We are proud to have played a key role in securing FDA clearance for the GlutenID Test,” said Scott Crawford of SoundRocket. “This milestone underscores SoundRocket’s expertise in regulatory social science research and our commitment to ensuring that consumers can safely and accurately interpret their genetic health risk results. As DTC genetic testing continues to evolve, SoundRocket remains at the forefront, guiding companies through the rigorous FDA 510(k) clearance process.”
A Legacy of Expertise in Genetic Health Risk Testing
The GlutenID Test is the latest in a growing list of FDA-cleared genetic health risk tests that have benefited from SoundRocket’s expertise in user comprehension research. SoundRocket has been involved in regulatory study design and execution for four of the five companies that have successfully obtained FDA clearance for direct-to-consumer genetic health risk tests to date, including:
- 23andMe’s Genetic Health Risk Tests (DEN160026) – The first FDA-cleared direct-to-consumer genetic health risk test (2017).
- AncestryDNA’s Factor V Leiden Genetic Health Risk Test (K192944, 2021) – A direct-to-consumer test assessing genetic risk for Factor V Leiden thrombophilia.
- Progenika’s AlphaID At Home Genetic Health Risk Service (K221420, 2022) – A test identifying genetic variants associated with alpha-1 antitrypsin deficiency.
- Targeted Genomics’ GlutenID Celiac GHR Test (K241456, 2025) – The latest direct-to-consumer genetic test to receive FDA clearance.
Partner with SoundRocket
If your company is developing a regulated medical or diagnostic device, an over-the-counter medication, or requires social science data collection from consumers or healthcare providers, SoundRocket provides expert support in user comprehension studies, label comprehension studies, self-selection studies, simulated use studies, risk analyses, and human factors studies. Our research ensures that your product meets regulatory requirements and is easily understood by consumers and healthcare professionals. Contact SoundRocket today to discuss how we can support your regulatory submission and compliance needs.For media inquiries, please contact:
Scott D Crawford
scott@soundrocket.com
1.734.395.8790
www.soundrocket.com