Targeted Genomics Receives FDA Clearance for First Direct-to-Consumer Celiac Disease Genetic Health Risk Test

IRVINE, Calif., Feb. 17, 2025 (GLOBE NEWSWIRE) — Targeted Genomics LLC, a family owned genetic testing Company, today announced receipt of U.S. Food and Drug Administration (FDA) 510(k) clearance for its Direct-to-Consumer GlutenID test. GlutenID analyzes genetic variants associated with increased genetic health risk (GHR) to develop celiac disease, the most common intestinal autoimmune disease worldwide.

The GlutenID GHR Test uses a proprietary next generation sequencing (NGS) genotyping and reporting strategy to detect celiac genetic variants in a User’s genomic DNA isolated from at-home collected saliva samples. GlutenID tests the relevant HLA genetic markers [DQ2, DQ8, DQ2.2, DQ7] and positive results are reported within a spectrum of risk. The finding of negative results, reported as Non-celiac Genetics (NCG), is indicative of a less than 1% chance of developing celiac disease over a lifetime. In total there are 15 possible celiac genetic combinations (GlutenIDs) and all Users will have one of them.

GlutenID is designed for high-throughput, rapid, economical genotyping to support celiac genetic risk screening for individuals, families, and populations. The FDA’s Decision Summary for the GlutenID test (K241456) determined its analytical performance including accuracy and reproducibility. User Comprehension Studies performed by the Company showed the testing process and reports to be easily understood by a group of over 300 demographically diverse Users.

“The root cause of celiac disease is genetic, but understanding celiac genetics is confusing for everyone, including physicians,” said Shelly Gunn MD, PhD, Founder and Medical Director of Targeted Genomics. “Our task in developing GlutenID was to simplify the testing and interpretation of celiac genetics allowing anyone to know their inherited genetic risk for developing celiac-related gluten sensitivity. Knowing the risk can help with diagnosis as well as treatment and prevention of celiac disease through a gluten free diet.” After receiving their 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.

This marks the company’s first FDA clearance for an at-home genetic health risk (GHR) test as a new medical device. With this clearance, Targeted Genomics furthers their mission to provide wellness-seeking consumers direct access to their genetic risk information without a prescription. GlutenID is available for purchase through the Company’s website.

About Targeted Genomics

Targeted Genomics is a family-owned company committed to inherited genetics and wellness. The GlutenID test was designed to identify root causes of celiac disease through a gradient of genetic risk.

CONTACT: Media Contact: Shelly Gunn MD, PhD
shelly@targeted-genomics.com