Targeted Genomics and OraSure Technologies Collaborate to Expand Direct-to-Consumer Celiac Genetic Testing
Targeted Genomics and OraSure Technologies have announced a commercial partnership to provide at-home, direct-to-consumer (DTC) celiac genetic testing to consumers in the U.S. more widely. The partnership will simplify testing and enhance access to genetic testing for those who are at a high risk of developing celiac disease.
Expanding Access to At-Home Celiac Genetic Testing
Conducted through a DNA-based test of saliva samples, GlutenID is the first and only U.S. FDA-cleared DTC genetic test for celiac disease risk, which measures all 15 possible combinations of the DQ2 and DQ8 celiac risk genes. The partnership enables consumers to obtain clinically relevant genetic risk information from the comfort of their own homes, utilizing a home-collection sample pick-up and OraSure's ORAcollect Dx device.
“This collaboration simplifies the testing process and brings celiac disease testing to the patient and family,” Carrie Eglinton Manner, OraSure Technologies' President and CEO, stated in the press release.
According to Precedence Research, the Direct-To-Consumer Genetic Testing Market size was calculated at USD 2.17 billion in 2025 and is predicted to increase from USD 2.45 billion in 2026 to approximately USD 11.02 billion by 2035, expanding at a CAGR of 17.64% from 2026 to 2035, driven by the growing demand for convenient and personalised forms of genetic health testing.
Industry Impact and Outlook
The alliance is projected to help increase adoption of consumer genomics products facilitated by the easy-to-use saliva-based specimen collection and FDA clearance of the genetic testing, especially in gastrointestinal and autoimmune disease risk assessment. This also highlights the increasing relevance of strategic collaboration for improving the availability of tests and the consumer experience in personalized health management.
The move is seen as helping to bolster the at-home genetic testing growth that continues to be fuelled by the adoption of new testing platforms, which deliver clinically validated testing that is easy to use and scalable. Expertise sharing between diagnostic providers like OraSure and targeted Genomics, sample collection technology partners, is crucial to the rapid innovation and access in the global DTC genetic testing market.