OraSure Technologies, Targeted Genomics Collaborate for DTC Genetic Celiac Disease Testing

Original from: 360dx

Targeted Genomics on Wednesday announced a commercial collaboration with OraSure Technologies for direct-to-consumer celiac disease testing using the OraCollect-Dx saliva collection device and GlutenID test.

Financial and other terms of the deal were not disclosed.

"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," Shelly Gunn, founder and medical director of Targeted Genomics, said in a statement. A gluten-free diet is the only therapy to prevent severe celiac disease complications, including small bowel cancers, she added.

Targeted Genomics' GlutenID test was cleared by the US Food and Drug Administration in February and assesses 15 risk genes for the intestinal autoimmune disease triggered by dietary gluten. It is available for prescription use or DTC at-home sample collection followed by CLIA lab-based next-generation sequencing and is the only cleared DTC genetic test for celiac disease, the Irvine, California-based firm said.

The OraCollect-Dx device, meanwhile, is made by OraSure's DNA Genotek subsidiary and obtained FDA clearance in 2022. 

"The path to celiac disease diagnosis can be challenging for those who suffer with the symptoms," said Carrie Eglinton Manner, president and CEO of Bethlehem, Pennsylvania-based OraSure. However, genetic testing with at-home sample collection can simplify the testing process, she added, "so patients can get actionable answers and, ultimately, relief."

Source: OraSure Technologies, Targeted Genomics Collaborate for DTC Genetic Celiac Disease Testing