SQI announces poster presentations on novel diagnostic assays at 7th International Congress on Autoimmunity

SQI Diagnostics Inc. (TSX-Venture: SQD), a medical systems automation company focused on evolving laboratory-based biomarker testing, today announced data from oral and poster presentations that highlights the Company's leadership position in the autoimmune diagnostics space.

The clinical data, which were presented in three separate sessions at the 7th International Congress on Autoimmunity in Slovenia last week, shows the specificity, sensitivity and utility of SQI's proprietary assays utilized in the diagnostic testing of novel biomarkers associated with rheumatoid arthritis, celiac disease and Crohn's disease.

"Sharing the results of our ongoing product development and commercialization program with the world's leading autoimmune researchers and clinicians raises SQI's profile within the autoimmune diagnostics community and supports SQI's mandate to stay at the forefront of this rapidly evolving industry," said Claude Ricks, CEO of SQI Diagnostics. "All of our results shared at the Congress indicate that our products are performing at the leading edge of assay performance when compared to predicate technologies."

SQI's poster presentation, entitled, `Clinical Diagnosis of Celiac Disease Biomarkers: Sensitivity and Specificity in a Novel 4-Plex Planar Microarray Assay', demonstrated that simultaneous multiplex detection of recognized gluten-sensitive enteropathic celiac disease biomarkers improves patient diagnosis. A novel multiplex serological assay simultaneously measured four celiac disease auto-antibody biomarkers, Gliadin IgA, Gliadin IgG together with tTG IgA and tTG IgG, using SQI's IgX PLEX(TM) assay. The Company expects to release a commercial multiplexed IgXplex Celiac Assay later this year.

In the study, serum samples of patients with confirmed celiac disease and normal controls were tested and the results compared with predicate and conventional immunoassays. The study demonstrated that the IgXplex test achieved glutanimase IgA sensitivity of 90.5% with 100% specificity; and glutanimase IgG sensitivity of 52.4% with 98.1% specificity; gliadin IgA sensitivity of 47.6% at 98.1% specificity; gliadin IgG sensitivity of 61.9% with 94.6% specificity. In a method-comparison study, clinical truth discrepancy resolution indicated that, when compared to predicate assays, the SQI Diagnostics' IgXplex Celiac resulted in increases in true positive determinations by 13.3% for gliadin IgA, 57.5% for gliadin IgG, 37.5% for glutanimase IgA and 8.3% for glutanimase IgG.

The Company's platform presentation, entitled, 'Clinical Utility to Monitor Anti-TNF Antibodies Using Novel IGX PLEX Planar Microarray Diagnostics', summarized data derived from a sensitive microarray assay that was used to measure anti-TNF-a using SQI's IgXPLEX (TM) assay. The multiplex planar microarray fluorescent immunoassay provides quantitative measurement for anti- TNF-a drug concentration for drugs such as Infliximab - which are often used to treat patients with Crohn's disease and rheumatoid arthritis- in each sample well of a 96-well, test microarray plate.

The IgX-PLEX Infliximab (RUO) assay provided 100% specificity in studies performed at SQI Diagnostics and Mount Sinai Hospital. The results of this testing correctly did not report the presence of the drug in healthy serum samples, but accurately reported drug levels when expected to be present, for example in patients responding to treatment. The assay confirms non interference of Bilirubin, hemoglobin, triglycerides, and human IgG. This novel microarray assay system detects and measures TNF-a blocker drug concentrations at high sensitivity and specificity, a usual tool to monitor drug levels in treated patients.

The results of the studies presented in the Company's second platform presentation, entitled, 'Early Diagnoses of CCP Auto-Antibodies in a 5-Plex Novel Planar Microarray RA Assay', demonstrated that early detection and monitoring of anti-CCP-IgA autoantibodies is beneficial in pre-symptomatic prognosis and early management of rheumatoid arthritis. A sensitive anti-CCP antibody assay (IgA, IgG) was tested for simultaneous measurement of rheumatoid factors (RF) -RF-IgA, IgG and IgM using SQI's IgX- PLEX assay.

This study showed that the 5-plex RA assay achieved 81.5% sensitivity and 95.0% specificity. At the fixed specificity of 97.5%, this anti-CCP assay was 4.2% more sensitive than single analyte anti-CCP tests in determining RA positive patient samples. SQI's novel 5-PLEX assay system will permit the simultaneous detection of early anti-CCP autoantibodies and rheumatoid factor immunoglobulins of rheumatoid arthritis with high sensitivity and specificity.




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