NEW YORK (GenomeWeb News) – SQI Diagnostics has received clearance from the Canadian government to market its biomarker-based microarray test for celiac disease, which runs on its multiplex testing kit, the Toronto-based company said today.
Health Canada has given a medical device license to SQI’s IgX Plex Celiac microarray test kit, which measures four biomarkers, for use on the SQiDworks platform.
Celiac disease is a digestive tract condition caused by the consumption of gluten that causes an immune reaction in the small intestine leading to damage to its surface and affecting its ability to absorb nutrients.
"As more assays become commercially available, the potential return on investment for labs that are considering purchasing the [SQI] technology increases, which may ultimately accelerate SQI's revenue ramp,” company President and CEO Claude Ricks said in a statement.
The company also said that it has submitted a 510(k) application with the US Food and Drug Administration for its Plex Celiac Assay and the SQiDworks diagnostics platform, and that the regulatory approval process is currently “on track.”