Targeted Genomics is proud to announce that our GlutenID™ genetic health risk test has received FDA 510(k) clearance. This clearance validates the accuracy, reliability, and usability of our direct-to-consumer (DTC) genetic screening test for celiac disease risk assessment.
The U.S. Food and Drug Administration (FDA) grants 510(k) clearance to medical devices that demonstrate substantial equivalence to a legally marketed device. This process ensures that GlutenID™ meets regulatory standards for analytical performance, accuracy, and user comprehension.
Our test is the first FDA-cleared DTC genetic health risk test for celiac disease, allowing consumers to assess their inherited genetic predisposition without requiring a prescription.
GlutenID™ analyzes HLA genetic markers associated with celiac disease risk, including DQ2, DQ8, DQ2.2, and DQ7. These markers are tested using our proprietary next-generation sequencing (NGS) genotyping process.
•At-home saliva collection makes testing easy and accessible.
•Results are reported on a spectrum of risk, helping users understand their likelihood of developing celiac-related gluten sensitivity.
• Negative results (Non-Celiac Genetics, or NCG) indicate a less than 1% lifetime risk of developing celiac disease.
•Each user receives one of 15 possible genetic profiles (GlutenIDs), providing clarity on their inherited risk.
Why Genetic Testing for Celiac Disease Matters
Celiac disease is an autoimmune disorder triggered by gluten consumption, affecting millions worldwide. While environmental factors play a role, genetics is the root cause. Understanding genetic predisposition can:
✔ Support early diagnosis for individuals with symptoms.
✔ Help families identify shared genetic risk.
✔ Aid in treatment and prevention through informed dietary choices.
Dr. Shelly Gunn, Founder and Medical Director of Targeted Genomics, emphasizes the importance of accessibility:
“Celiac genetics can be complex—even for physicians. GlutenID™ simplifies testing and interpretation, empowering individuals to understand their inherited risk and take proactive steps toward wellness.”
The FDA’s decision summary (K241456) confirmed GlutenID™’s accuracy and reproducibility through rigorous analytical performance assessments. Additionally, our user comprehension studies with over 300 participants demonstrated that consumers clearly understood the testing process and results.
All GlutenID™ users are encouraged to consult with a licensed genetic counselor or healthcare provider before making any changes to their diet or lifestyle.
GlutenID™ is now available for purchase directly through our website. This FDA-cleared at-home genetic health risk test makes it easier than ever to understand your genetic predisposition to celiac disease and make informed health decisions.
