Targeted Genomics, OraSure Expand Access To At-Home Celiac Genetic Testing

(RTTNews) - Targeted Genomics LLC, creator of GlutenID—the first and only FDA-cleared direct-to-consumer genetic test for celiac disease—has entered a commercial partnership with OraSure Technologies, Inc. (OSUR), the maker of ORAcollect Dx.

This collaboration aims to broaden the availability of at-home celiac disease genetic screening.

Celiac disease, a widespread autoimmune condition triggered by gluten in genetically predisposed individuals, is primarily linked to the DQ2 and/or DQ8 risk genes. GlutenID evaluates all 15 genetic combinations associated with celiac risk by analyzing genomic DNA from saliva samples collected using the ORAcollect®·Dx device.

Test results place individuals on a risk spectrum, helping those with elevated risk take preventive steps through a gluten-free diet. Users are advised to consult healthcare professionals before making dietary or lifestyle changes.

OraSure CEO Carrie Eglinton Manner highlighted that the partnership simplifies the testing process by allowing at-home sample collection, offering easier access to actionable health information and relief for those with celiac symptoms. She emphasized that the FDA-cleared ORAcollect®·Dx device integrates seamlessly with GlutenID, enhancing convenience for users.

Shelly Gunn, MD PhD, Founder and Medical Director of Targeted Genomics, noted that the collaboration supports their mission to provide consumers with direct access to personal genetic risk data. She stressed that a lifelong gluten-free diet remains the only effective prevention against serious complications like small bowel cancers in individuals with celiac disease.

To further discuss the development of FDA-cleared genetic health risk tests, Targeted Genomics and DNA Genotek (a subsidiary of OraSure) will co-host a webinar titled "Insights from the development of a U.S. FDA cleared genetic health risk test" on May 21, 2025, at 1 p.m. EST.

OSUR is currently trading at $2.5102 or 5.28% lower on the Nasdaq Global Select Market.