NEW YORK – Targeted Genomics said Tuesday that it received 510(k) clearance from the US Food and Drug Administration for its direct-to-consumer GlutenID test for the genetic risk of celiac disease.
The next-generation sequencing-based assay detects HLA genetic markers associated with the risk of developing celiac disease from user saliva samples collected at home. Positive results are reported within a spectrum of risk, and a negative result indicates a less than 1 percent lifetime chance of developing the autoimmune gastrointestinal disorder.
The Irvine, California-based company recommends that after receiving their GlutenID results, users consult a genetic counselor or their healthcare provider before making any lifestyle or dietary changes.
This marks the company's first FDA clearance for an at-home genetic test.
"The root cause of celiac disease is genetic, but understanding celiac genetics is confusing for everyone, including physicians," Shelly Gunn, founder and medical director of Targeted Genomics, said in a statement. "Our task in developing GlutenID was to simplify the testing and interpretation of celiac genetics allowing anyone to know their inherited genetic risk for developing celiac-related gluten sensitivity. Knowing the risk can help with diagnosis as well as treatment and prevention of celiac disease through a gluten-free diet."