US-based genetic testing company Targeted Genomics has received the US Food and Drug Administration (FDA) 510(k) approval for its Direct-to-Consumer GlutenID test.
GlutenID is designed to analyse the genetic variants associated with elevated genetic health risk (GHR) to develop celiac disease, a common intestinal autoimmune disease.
The GHR test uses a unique next-generation sequencing (NGS) genotyping and reporting strategy to detect celiac genetic variants in a user’s genomic DNA.
The genomic DNA is isolated from the saliva samples collected at home.
The GlutenID test examines relevant human leukocyte antigen (HLA) genetic markers, with positive results reported within a spectrum of risk.
The finding of negative results, reported as Non-celiac Genetics (NCG), indicate a less than 1% chance of developing celiac disease over a lifetime.
There are 15 possible celiac genetic combinations (GlutenIDs), one present in all the users.
Targeted Genomics founder and medical director Shelly Gunn said: “The root cause of celiac disease is genetic, but understanding celiac genetics is confusing for everyone, including physicians.
“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.”
The GlutenID test is designed for high-throughput, rapid, economical genotyping to support celiac genetic risk screening for individuals, families, and populations.
The US health agency’s Decision Summary for the GlutenID test determined its analytical performance, including accuracy and reproducibility.
Targeted Genomics conducted user comprehension studies, which showed that the testing process and reports were easily understood by more than 300 diverse users.
After test results, users are recommended to consult with a licensed genetic counsellor or healthcare provider before making any dietary or lifestyle changes.
Targeted Genomics said the FDA approval advances its strategy to provide wellness-seeking consumers with direct access to their genetic risk information without a prescription.
