The US Food and Drug Administration (FDA) has granted 510(k) clearance to Targeted Genomics’ GlutenID test, designed to screen for genetic markers associated with celiac disease, an autoimmune condition affecting the intestine.
This development marks the company’s initial FDA clearance for an at-home genetic health risk (GHR) test.
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Leveraging a next-generation sequencing (NGS) genotyping and reporting approach, the direct-to-consumer test examines the genomic DNA of users isolated from collected saliva samples to identify celiac genetic variants.
There are a total of 15 possible celiac genetic combinations. GlutenID tests for the relevant human leukocyte antigens (HLA) genetic markers and categorises outcomes within a spectrum of risk.
Users who test negative for these markers, reported as non-celiac genetics (NCG), have less than a 1% lifetime risk of developing the condition.
The FDA’s Decision Summary of the test (K241456) included an evaluation of its analytical performance, such as reproducibility and accuracy.
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By GlobalDataAdditionally, comprehension studies conducted by Targeted Genomics confirmed that the testing process and reports were understood easily by more than 300 demographically diverse users.
The company encourages all users of the GlutenID test to seek advice from a licenced genetic counsellor or healthcare provider before making any dietary or lifestyle changes based on their results.
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.”
Tailored for quick and economical genotyping, the test facilitates widespread genetic risk screening for individuals and their families. It is currently available for purchase directly from the company’s website.
