Laval, Quebec, January 25, 2013 – Algorithme Pharma and SQI Diagnostics’ (“SQI”) announced that they are using SQI’s Ig_PlexTM multiplexing technology to develop a multiplex proof of concept assay targeted at immunogenicity testing of heparin and heparin-based low molecular weight (LMWT) compounds. SQI and Algorithme aim to present the results of the proof of concept studies at the up-coming 14th Annual Immunogenicity for Biotherapeutics Conference in Baltimore 18-20 March, in a presentation titled “A Novel Approach for Multiplexed Detection, Isotyping, and Quantitation of IgG, IgA, and IgM PF4/Heparin Antibodies using SQI Diagnostics’ Ig_PlexTM Technology”.
Heparin and LMWT heparins are among the most widely prescribed anticoagulants in hospitalized patients. It is well known that a subpopulation of patients exposed to heparin drugs develop antibodies of all 3 immunoglobulin classes (IgG, IgA, IgM) that can induce Heparin-Induced Thrombocytopenia (HIT) and in some cases thrombosis.
This proof of concept assay is targeted towards drug development testing to determine patient immunogenic responses to heparin and heparin-based LMWT biosimilar compounds.
The potential benefits to sponsors of using this technology include providing the quantitative results for all 3 isotypes of HIT in a single test as well as utilizing SQI’s automated systems to significantly improve the time required to receive immunogenicity results.
“Algorithme is excited to work with SQI to develop this unique multiplex HIT assay”’ Robert Massé, Ph.D., Vice President Large Molecule Bioanalysis of Algorithme Pharma. “Because HIT antibodies are potentially produced with all heparin-based compounds, Algorithme, with this proof of concept will have a ‘shelf ready’ multiplexed assay ready to implement very competitive HIT testing to the many pharmaceutical companies who are building heparin compounds”.
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.
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