SQI Diagnostics Inc. (SQD.V) said Thursday that the United States Food and Drug Administration has received the company's 510(k) submission seeking marketing clearance in the U.S. for the company's IgX PLEX Celiac Assay and automated SQiDworks Diagnostics Platform.
Additionally, SQI said that it has filed a Class II Medical Device License Application with Health Canada to permit the company to market the IgX PLEX Celiac test and platform in Canada.
SQI's IgX PLEX Celiac panel provides multiplex testing for four biomarkers associated with celiac disease including Anti-Tissue Transglutaminase: IgG & IgA and Anti-Gliadin IgG &IgA.
Celiac disease is a digestive condition brought on by the consumption of the protein gluten, which is found in foods containing wheat, barley or rye. Celiac disease causes an immune reaction in the small intestine, causing damage to the surface of the small intestine and an inability to absorb certain nutrients.
In addition to the IgX PLEX Celiac panel, SQI said, it is moving forward with the product development process for IgX PLEX Vasculitis, IgX PLEX IA, and IgX PLEX SLE panels this calendar year.
The company anticipates that more IgX PLEX content will lead to an increase in customer evaluations, commercial adoption and revenue.
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