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SQI Diagnostics obtains Health Canada license for celiac disease test kit

SQI Diagnostics, a life sciences and diagnostics company, has obtained marketing license from Health Canada for its multiplexed Ig_plex Celiac DGP panel, intended for use in clinical laboratories as an aid in the diagnosis of celiac disease.

The celiac disease test kit, which operates on sqid-X system, provides semi-quantitative determination of the IgG and IgA immunoglobulin classes of DGP (deaminated gliadin peptide) and tTG (anti-tissue transglutaminase) antibodies in a single test requiring only one human sample.

According to SQI Diagnostics, overall agreement between the commercially available predicate methods for detecting the four analytes compared with the Ig_plex Celiac DGP panel, which detected the four distinct analytes simultaneously, was very high.

SQI Diagnostics CEO Andrew Morris noted this panel will provide clinicians with a valuable and rapid tool to quantify the levels of multiple key biomarkers associated with celiac disease.

"Furthermore, this panel quantifies both peptide biomarkers and antibody biomarkers simultaneously, highlighting the ability of SQI’s platform to detect, measure and subtype a range a protein types within a single multiplexed test, enabling a whole new class of diagnostic combinations to be possible," Morris added.

SQI Diagnostics is filing for regulatory approvals for the Ig_plex Celiac DGP panel in additional jurisdictions.