After securing a Health Canada license for its second-generation celiac-disease test, Toronto's SQI Diagnostics is now planning to submit the assay to US regulators and launch it in Europe later this year.
SQI's IgXPlex Celiac Panel, a quantitative 4-plex test that runs on the firm's automated SQiDworks diagnostics platform, received a Health Canada license, the firm announced last week.
The clearance follows Canadian approval last September of its IgX Plex Celiac microarray test.
The key difference between the first and second generations of the tests is that the new one is quantitative, whereas the first one was qualitative, according to SQI Chief Financial Officer Andrew Morris.
More specifically, the second-generation test simultaneously measures and reports four analytes: anti-gliadin IgA, anti-gliadin IgG, anti-tissue transglutaminase, and anti-tissue transglutaminase IgG. The first version, meantime, reports the presence of these markers but does not measure their quantity.
"Management believes that with both the qualitative and quantitative products that we can address a broader customer demand on the platform," Morris told BioArray News this week.
According to Morris, SQI is currently developing a 6-plex version of the IgX Plex celiac test, which it hopes to submit to the US Food and Drug Administration.
The firm said in a statement that this test adds to the current 4-plex panel deaminated gliadin IgA and IgG, which it calls "emerging biomarkers."
Morris declined to elaborate on the company's filing plans.
"We are making no statement regarding the performance characteristics of any products planned for filing in the US market, only that it will be [the] Celiac Quantitative Assay and expect it to be a 6-plex" test, he said.
Celiac disease is an autoimmune disorder brought on by the consumption of the protein gluten, which is found in foods containing wheat, barley, or rye. The disease causes an immune reaction in the small intestine, causing damage to the surface of the small intestine and an inability to absorb certain nutrients.
Founded in 2006, SQI has accumulated a portfolio that consists of its internally developed, automated SQiDWorks system and SqiDman, a semi-automated version of SQiDWorks for lower-throughput users. The company also sells the QuantiSpot, a 96-well microarray consumable.
The SQiDWorks and SqiDman systems 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 SQI.
In addition to its suite of celiac assays, SQI is also developing a quantitative 12-plex panel for lupus and a quantitative 3-plex panel for vasculitis. These assays "remain on track to be filed with various regulatory bodies including Health Canada and the FDA this year," the firm said in the statement.
The company last month announced it had entered into a clinical validation agreement with the University of North Carolina Kidney Center to evaluate its vasculitis panel.
Morris declined to elaborate on the assays or when they might receive clearance. CEO Claude Ricks said in a statement that the firm is "working diligently" to bring to the US market its second-generation quantitative products, including the lupus and vasculitis tests.
SQI has received such clearance in the past. In 2009, it received 510(k) clearance to sell its IgXplex RA test in the US. The assay is used to help physicians diagnose and monitor patients with the disease, those who carry RF-IgA and RF-IgM, and those who carry anti-CCP-IgG, a biomarker that has been adopted in recent years.
SQI has held a Health Canada license for its RA test since 2008 (BAN 8/10/2010).
As it intensifies its efforts to achieve FDA clearance for its tests, SQI also expects to launch sales efforts in Europe in the second half of this year for its SQiDworks platform and RA and celiac-disease assays.
"We have been always in a position to launch our platform and products in Europe when we achieved a critical mass of content to support operations in the EU," Morris said this week. "This will start when we have [the] two assays and the platform CE Marked, and closer to the point when we will have more certainty on the ability to CE Mark a third assay."
Morris did not elaborate on when the firm expects to achieve CE Marks for its assays. He said that the firm will initially sell directly to European customers.
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