TORONTO - SQI Diagnostics Inc. (TSX-V: SQD), a life sciences and diagnostics company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics (“SQI”), and Algorithme Pharma (“Algorithme”) today announced that they have completed the multiplexed proof of concept assay targeted at immunogenicity testing of heparin and heparin-based low molecular weight (LMWT) biosimilar compounds using SQI’s Ig_PLEX™ multiplexing technology. SQI and Algorithme jointly presented the results of the proof of concept studies at the recent 14th Annual Immunogenicity for Biotherapeutics Conference in Baltimore held 18-20 March.
“A Novel Approach for Multiplexed Detection, Isotyping, and Quantitation of IgG, IgA, and IgM PF4/Heparin Antibodies using SQI Diagnostics’ Ig_PLEX™ Technology”
The presentation titled “A Novel Approach for Multiplexed Detection, Isotyping, and Quantitation of IgG, IgA, and IgM PF4/Heparin Antibodies using SQI Diagnostics’ Ig_PLEX™ Technology” included data illustrating the high sensitivity, specificity and precision of the assay. Among other important data from the development studies presented include a limit of detection of 2 ng/ml, overall agreement with clinically validated samples of over 100% for IgG and IgA anti-PF4/Heparin antibodies and 87% for the IgM isotype measured with precision in the range of 9% to 15% (depending on isotype). For more details regarding the technology and assay performance presented please visit www.sqidiagnostics.com/resources/ADApres.pdf.
“Algorithme was very excited to co-present the results of this very rapid development project using the Ig_PLEX technology alongside SQI,” said Robert Massé, Ph.D., Vice President Large Molecule Bioanalysis of Algorithme Pharma. “With this proof of concept completed, Algorithme has a ‘shelf ready’ multiplexed assay with very compelling performance that we can market to the many pharmaceutical companies who are building heparin and other types of biosimilar compounds that need to be evaluated in Bioequivalence or Phase-1 studies.”
A commercial assay based on the proof of concept is targeted at drug development testing to determine patient immunogenic responses to heparin and heparin-based LMWT biosimilar compounds. The commercial assay will be available shortly on all of SQI’s fully-automated analytical systems including its SQiDlite™ and SQiDworks™ systems. The HIT assay was completed in approximately five weeks and utilized, among other things, SQI Diagnostics’ Assay Development Toolkit, a proprietary set of software applications to assist scientists to develop multiplexed Ig_PLEX assays.
About Algorithme Pharma
As a major global player in Clinical Research and Bioanalysis, Algorithme Pharma provides a wide range of services for early stage clinical development studies to the pharmaceutical, and biotechnology industries. In addition to its multi-unit clinical facilities in Canada and the United Kingdom, Algorithme Pharma offers different services including protocol designs, CTD/ICH clinical reports, data management, biostatistics, quality assurance and regulatory affairs. Successfully audited by the US FDA, Canada TPD, Brazil ANVISA, France ANSM, UK MHRA and Austria AGES regulatory authorities, Algorithme Pharma conducts over 200 clinical trials per year.
About SQI Diagnostics
SQI Diagnostics is a life sciences and diagnostics company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics. The Company’s proprietary microarray tests and fully-automated systems are designed to simplify protein and antibody testing workflow, increase throughput, reduce costs and provide excellent data quality. For more information, please visit www.sqidiagnostics.com.
For more information about SQiDliteTM and SQI Diagnostics’ suite of biopharma and clinical diagnostic products and services please visit www.sqidiagnostics.com, or contact SQI at: email@example.com.
SQI Diagnostics Inc.
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