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.
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.
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This press release contains certain forward-looking statements, including, without limitation, statements containing the words "may", "plan", "will", "estimate", "continue", "anticipate", "intend", "expect", "believe", "in the process", "benefits", "leading to", "possible" "is subject to" and other similar expressions which constitute "forward-looking information" within the meaning of applicable securities laws. Forward-looking statements reflect the Company's current expectation and assumptions, and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements involve risks and uncertainties including, but not limited to: the ability of our patents to adequately protect our rights or permit us to gain or keep any competitive advantage; our ability to market and sell our novel multiplexing technologies and detection platforms; our ability to maintain any technical or product advantages; our ability to continue to market and sell our products; potential supply problems or price fluctuations with sole source or other third-party suppliers on which SQI is dependent; SQI's ability to increase customer orders and manufacturing volumes; adverse changes in general economic conditions; impact of healthcare reform legislation; and, SQI's ability to raise additional funds in the future on acceptable terms or at all. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks and uncertainties and other risks detailed from time-to-time in the Company's ongoing filings with the securities regulatory authorities, which filings can be found at www.sedar.com. Actual results, events, and performance may differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements either as a result of new information, future events or otherwise, except as required by applicable securities laws.
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