FDA Clears First Direct-to-Consumer Genetic Test for Celiac Disease Risk

• Targeted Genomics has received FDA 510(k) clearance for GlutenID, the first direct-to-consumer genetic test that assesses risk for celiac disease by analyzing HLA genetic markers.
• The at-home saliva test identifies 15 possible genetic combinations associated with celiac disease risk, with negative results indicating less than 1% chance of developing the condition over a lifetime.
• Targeted Genomics has announced a commercial collaboration with OraSure Technologies to expand consumer access to celiac genetic testing using FDA-cleared ORAcollect·Dx saliva collection devices.

Targeted Genomics LLC has secured U.S. Food and Drug Administration (FDA) 510(k) clearance for GlutenID, the first direct-to-consumer genetic test designed to assess an individual's risk of developing celiac disease, the most common intestinal autoimmune disorder worldwide.

The Irvine, California-based family-owned company developed GlutenID to analyze specific genetic variants associated with celiac disease using next-generation sequencing (NGS) technology on DNA collected from at-home saliva samples. The test examines HLA genetic markers—DQ2, DQ8, DQ2.2, and DQ7—that are strongly linked to celiac disease susceptibility.

"The root cause of celiac disease is genetic, but understanding celiac genetics is confusing for everyone, including physicians," said Dr. Shelly Gunn, 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."

Test Performance and Reporting

The FDA's Decision Summary for GlutenID (K241456) confirmed the test's analytical performance, including accuracy and reproducibility. User comprehension studies involving over 300 demographically diverse participants demonstrated that the testing process and reports were easily understood.

GlutenID identifies all 15 possible genetic combinations related to celiac disease risk, which the company refers to as "GlutenIDs." Test results are reported within a spectrum of risk, with negative results—reported as Non-celiac Genetics (NCG)—indicating less than 1% chance of developing celiac disease over a lifetime.

The test is designed for high-throughput, rapid, and economical genotyping to support celiac genetic risk screening for individuals, families, and populations. Targeted Genomics emphasizes that all users should consult with a licensed genetic counselor or healthcare provider before making dietary or lifestyle changes based on test results.

Commercial Collaboration with OraSure Technologies

In May 2025, Targeted Genomics announced a commercial collaboration with OraSure Technologies, Inc. (NASDAQ: OSUR), manufacturer of ORAcollect·Dx, the only FDA-cleared saliva collection device for general over-the-counter use. This partnership aims to expand consumer access to at-home celiac genetic testing.

"The path to celiac disease diagnosis can be challenging for those who suffer with the symptoms," said Carrie Eglinton Manner, President and Chief Executive Officer of OraSure Technologies. "This test allows for at-home collection of saliva samples, simplifying the testing process so patients can get actionable answers and, ultimately, relief."

Clinical Significance

Celiac disease is triggered by dietary gluten in genetically predisposed individuals. Currently, a lifelong gluten-free diet is the only proven effective therapy for preventing potentially severe complications, including small bowel cancers.

Identification of increased-risk individuals can assist with diagnosis and prevention of celiac disease symptoms through informed adoption of a gluten-free diet. This is particularly important given the challenges many patients face in obtaining a definitive diagnosis.

"This new arrangement provides an opportunity for us to work with an experienced company in furthering our mission to provide wellness seeking consumers direct access to their genetic risk information," Dr. Gunn noted regarding the OraSure collaboration.

Market Availability

GlutenID is now available for purchase through Targeted Genomics' website. This marks the company's first FDA clearance for an at-home genetic health risk test as a new medical device, furthering their mission to provide consumers direct access to genetic risk information without requiring a prescription.

The companies have scheduled a joint webinar titled "Insights from the development of a U.S. FDA cleared genetic health risk test" for May 21, 2025, to discuss the development process and regulatory considerations for direct-to-consumer genetic tests.

Targeted Genomics develops testing solutions through its affiliated College of American Pathologists (CAP) accredited and Clinical Laboratory Improvement Amendment (CLIA) certified molecular laboratory, focusing on inherited genetics and wellness applications.