, 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 are using SQI's Ig_Plex™ multiplexing technology to develop a multiplex proof of concept assay targeted at immunogenicity testing of heparin and heparin-based low molecular weight (LMWT) biosimilar compounds. SQI and Algorithme will present the results of the proof of concept studies at the upcoming 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_Plex™ Technology".
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 is expected to be available on all of SQI's fully-automated analytical systems including its SQiDlite™ and SQiDworks™ systems.
The potential benefits to drug development companies and CROs using SQI's CustomPlex tests include providing the quantitative results for all three isotypes of heparin-induced thrombocytopenia (HIT) antibodies in a single test as well as utilizing SQI's automated systems to significantly improve the benefits of multiplexing and markedly reducing the time and labor required to process and analyze blood samples during drug development immunogenicity testing.
"Algorithme is excited to work with SQI to develop this unique multiplex HIT assay," said Robert Massé, Ph.D., Vice President Large Molecule Bioanalysis of Algorithme Pharma. "Because HIT antibodies are potentially produced with all heparin-based biosimilars, Algorithme, with this proof of concept completed, will have a 'shelf ready' multiplexed assay ready to implement and deliver very competitive HIT testing to the many pharmaceutical companies who are building heparin biosimilar compounds."
The heparin market has been estimated to grow at a CAGR of 11.2 percent over the period 2011-2015 (Technavio, Global Heparin Market 2011 – 2015, November 2012). Heparin and its biosimilar compounds are currently estimated to generate revenues of approximately $1 billion per year. There are several heparin-based biosimilar compounds currently on the market and an estimated eight biosimilars in development. Heparin is used to treat a variety of conditions such as deep vein thrombosis, pulmonary embolism, and acute coronary syndrome (ACS) to prevent clotting during dialysis and to avert intravascular coagulation during open heart surgical procedures.
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 AFSSAPS, UK MHRA and Austria AGES regulatory authorities, Algorithme Pharma conducts over 275 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.
Sales and Marketing ContactRuss Peloquin
Vice President, Global Commercial Operations
Investor Relations ContactAndrew Morris
Chief Executive Officer
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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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