Targeted Genomics Launches CeliacDx Consumer-Initiated Testing ServiceIRVINE, Calif., Oct. 28, 2025 (GLOBE NEWSWIRE) -- Targeted Genomics LLC, developer of GlutenID, the only U.S. Food and Drug Administration (FDA) cleared test for celiac genetics, today announced the launch of their consumer-initiated laboratory testing service, CeliacDx designed to address the hidden epidemic of undiagnosed celiac disease.
Targeted Genomics Announces Commercial Collaboration with OraSure Technologies for Direct to Consumer (DTC) Celiac Genetic TestingIRVINE, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- 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.
Targeted Genomics Receives FDA Clearance for First Direct-to-Consumer Celiac Disease Genetic Health Risk TestIRVINE, 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.
