OSUR OraSure Technologies Inc

Targeted Genomics LLC, developer of GlutenID, the first and only U.S. Food and Drug Administration (FDA) cleared direct-to-consumer (DTC) test for celiac disease genetics, today 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 (OTC) use. The collaboration expands consumer access to at-home celiac genetic testing. 

Celiac disease, the most common intestinal autoimmune disease worldwide, is triggered by dietary gluten in people who carry the DQ2 and/or DQ8 celiac risk genes. Individuals who test negative for these genes have less than 1% chance for developing celiac disease during their lifetime. GlutenID assesses all 15 possible genetic combinations of the risk genes (GlutenIDs) using genomic DNA isolated from ORAcollect®·Dx saliva samples. Genetic results are reported within a spectrum of celiac disease risk. Identification of increased-risk individuals assists with diagnosis and prevention of celiac disease symptoms through informed adoption of a gluten free diet. GlutenID test users are encouraged to consult with a licensed healthcare provider or genetic counselor before making changes to their diet or lifestyle.  

“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, for OraSure Technologies, Inc. “This test allows for at-home collection of saliva samples, simplifying the testing process so patients can get actionable answers and, ultimately, relief. The ORAcollect®·Dx saliva collection device, with its FDA- clearance for prescription and over-the-counter use, integrates easily into the GlutenID test system, and we are proud to collaborate with Targeted Genomics to make celiac disease screening more accessible and convenient for at-risk individuals and their families.”  

“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,” said Shelly Gunn MD PhD, Founder and Medical Director for Targeted Genomics, LLC. “Currently a lifelong gluten free diet is the only proven and effective therapy for prevention of potentially severe celiac disease complications including small bowel cancers.”  

Targeted Genomics and DNA Genotek, the subsidiary of OraSure Technologies that makes the ORAcollect®·Dx saliva collection device, have scheduled a joint webinar entitled “Insights from the development of a U.S. FDA cleared genetic health risk test” on May 21, 2025 at 1 p.m. EST. Registration information can be accessed with this link: https://www.clinicallab.com/insights-from-development-of-an-fda-cleared-genetic-health-risk-test-navigating-quality-and-compliance-in-the-evolving-regulatory-landscape-28253  

About Targeted Genomics 

Targeted Genomics, LLC develops testing solutions for inherited genetics and wellness through its affiliated College of American Pathologists (CAP) accredited and Clinical Laboratory Improvement Amendment (CLIA) certified molecular laboratory. The GlutenID test was designed to identify root causes of celiac disease through a gradient of genetic risk. For more information on Targeted Genomics, please visit www.targeted-genomics.com.

About OraSure Technologies 

OraSure Technologies, Inc. (“OraSure”) transforms health through actionable insight and powers the shift that connects people to healthcare wherever they are. OraSure improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. OraSure, together with its wholly-owned subsidiaries, DNA Genotek Inc. and Sherlock Biosciences, Inc., is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com 

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/4e39b14d-8fdf-425d-b2c9-5c1ca14f8dba

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