SQI Diagnostics Inc., a life sciences and diagnostics company that develops and commercializes proprietary technologies and products for advanced microarray diagnostics, and Algorithme Pharma last week 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.
Source: SQI Diagnostics press release