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FDA Clears SQI Diagnostics' Array-Based RA Test for Sale in US

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By Justin Petrone

SQI Diagnostics said this week that the US Food and Drug Administration has cleared for marketing its SQiDworks multiplex diagnostics platform and IgXPlex rheumatoid arthritis assay.

The SQiDworks automated platform uses the firm's IgXPlex technology to allow multiplexed measurement of target antibody sub-classes IgA, IgG, and IgM for multiple biomarkers. The RA assay is used to help physicians diagnose and monitor patients with rheumatoid arthritis, those who carry RF-IgA and RF-IgM, and those who carry anti-CCP-IgG, a biomarker that has been rapidly adopted over the last five years, said Toronto-based SQI.

The clearance comes nearly a year after Health Canada granted SQI a license to sell its rheumatoid arthritis test in Canada. According to an SQI official, the ability to sell to the US not only gives the firm access to a larger market, but "more credibility" globally.

"I think that even in other markets like the Canadian market, FDA clearance gives us more credibility; it helps us with our marketing in other parts of the world," Chief Financial Officer Andrew Morris told BioArray News this week.

The company's main competition includes Dundee, UK-based Axis-Shield, which sells an enzyme-linked immunoabsorbent assay for anti-CCP detection called Diastat anti-CCP. Uppsala, Sweden-based testing firm Phadia also sells an automated anti-CCP test called Elia, for which it received FDA clearance in 2006.

SQI’s platform consists of its internally developed SQiDworks workstation and IgXPLEX, a 96-well microarray consumable. Workstation users can typically process multiplexed assays to quantify serum concentrations of up to 12 individual biomarkers, or qualitatively detect up to 24 biomarkers per patient, according to the firm.

The RA test combines enzyme-linked immunosorbent assays previously available for rheumatoid factors IgG, IgA, and IgM with anti-cyclic citrullinated peptide antibodies into one multiplexed, automated assay that can help diagnose and monitor RA in patients. SQI submitted the assay and platform to the FDA for clearance last year, around the same time it received its Health Canada licenses (see BAN 12/2/2008).

According to Morris, SQI has a pipeline of tests that it hopes to submit to the FDA within the next 18 months. Assays in development include tests for celiac disease, inflammatory bowel disease, vasculitis, and a research-use-only screen for determining the amount of anti-tumor necrosis factor agents in serum. Morris said that SQI also has a lupus diagnostic in development.

He added that growing the test menu was "critical" for the firm because SQI is targeting some customers, such as reference labs, that prefer to invest in systems that support a number of tests.

Last year, SQI hired Thomas O’Connor as vice president of sales and marketing. O’Connor previously held senior sales positions at Beckman Coulter and Luminex and has overseen the creation of a sales force capable of reaching reference labs in the US and Canada.

This week, Morris said that SQI is "poised and ready to go" in the US market. Over the past 18 months, the firm raised C$4.6 million ($4.3 million) to support its R&D and sales and marketing efforts (see BAN 1/27/2009). The private stock placements were managed by Toronto-based Kingsdale Capital Holdings. SQI trades on the Toronto Stock Exchange under the ticker symbol SQD, and is listed in its TSX Ventures index.

SQI had C$4.1 million on its balance sheet as of June 30, the end of the firm's fiscal third quarter. Morris said that SQI hopes to use the recent FDA clearance of its IgXPLEX RA assay and SqiDworks platform to "assess more opportunities to bring more capital in."

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