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SQI, Algorithme Pharma Develop Heparin Screening Assay, Plan Near-Term Commercial Launch

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SQI Diagnosticsand Algorithme Pharma have developed a microarray-based assay targeted at the immunogenicity testing of heparin and heparin-based low molecular weight biosimilar compounds.

The two Canadian companies announced their collaboration in January and demonstrated the results of their proof-of-concept studies at the recent Annual Immunogenicity for Biotherapeutics Conference, held last week in Baltimore. The described multiplexed immunoassay can be used to characterize antibodies' isotype distribution using microarrays with a reporter cocktail of differentially labeled secondary antibodies, according to a presentation posted online by the firms.

Though heparin is widely used as an injectable anticoagulant, it is currently being evaluated in clinical trials to treat a number of other conditions including asthma, inflammatory bowel disease, and adult respiratory distress syndrome.

As a contract research organization, Montreal-based Algorithme will offer SQI's assays to the "many pharmaceutical companies that are building heparin and other types of biosimilar compounds that need to be evaluated in bioequivalence or phase-1 studies," Robert Massé, vice president of large molecule bioanalysis at Algorithme, said in a statement.

Andrew Morris, chief financial officer at Toronto-based SQI, told BioArray News this week that while Algorithme helped to develop and invested in the new assay, SQI maintains "all commercial rights" and IP related to the test.

According to Morris, SQI will "shortly" launch an automated version of the assay that can be run on the firm's SQiDlite and SQiDworks systems. He declined to provide a launch date for the assay, but said that it will "not take months and months" to automate it.

Though Algorithme does not have exclusive access to the assay, Morris said that the CRO does have "first mover advantage because they got to see it first." And, as Algorithme intends to offer the test to its partners, SQI stands to benefit from its ongoing relationship with the company.

Morris said that most heparin immunogenicity testing is currently conducted using enzyme-linked immunosorbent assays. SQI has traditionally positioned its automated platforms, which can process 96 samples at a time, as an alternative to manual ELISAs.

Morris said the assay-development project with Algorithme was significant not only because of the commercial opportunities for the firm, but because it showcases its recently introduced Customplex assay development and manufacturing services.

SQI has multiple assays that have been cleared by Health Canada and the US Food and Drug Administration for clinical use, including its IgXplex RA test, which is designed to help physicians diagnose and monitor patients with rheumatoid arthritis, and its IgXPlex celiac qualitative assay, a four-plex microarray-based assay test for anti-tissue transglutaminase IgG and IgA. However, it has emphasized its assay development business in recent quarters to provide it with a more immediate source of revenue (BAN 8/28/2011).

According to Morris, SQI's Customplex business is "growing nicely." Though he declined to discuss revenue numbers for the segment, he said that the work with Algorithme was the first publicly discussed Customplex deal that provided the firm with a "real commercial opportunity" as well as a way to showcase its "quick" turnaround time of five weeks from beginning work to delivering a proof-of-concept assay. "In that time, we were able to get the assay into a state of readiness so that it could be presented in a peer environment," he noted.

SQI has a number of similar opportunities in the pipeline, though Morris declined to elaborate on SQI's partners or the applications pursued. He said that the firm's Customplex customers generally fall into two categories: a so-called "pure customer opportunity" where SQI will act as an original equipment manufacturer for another company, or partner collaborations, such as the one with Algorithme.

As SQI looks to generate revenues through its Customplex business segment, the firm is also looking for a partner. In November it formed a special committee to review strategic alternatives, which could include a possible merger or sale.
Morris said this week that this "strategic process continues" and that SQI is looking for prospective partners.

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