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SQI Diagnostics to Submit Array-Based Assays to FDA in 2008

NEW YORK (GenomeWeb News) - SQI Diagnostics, a Toronto-based automated medical systems developer, plans to submit array-based assays for rheumatoid arthritis and thrombosis to the US Food and Drug Administration in 2008 for a possible market launch that year, GenomeWeb Daily News sister publication BioArray News reported last week.
 
SQI recently completed an internal validation study of its QuantiSpot Rheumatoid Panel, and said in a statement that the test “generates equivalent results to current technologies” like ELISAs, while requiring less time and labor. The company is now shipping the system to undisclosed external validation sites where it will collect data that will be useful in its FDA submission package next year.
 
Andrew Morris, SQI’s chief financial officer, told BioArray News via e-mail that the company’s automated, multiplex technology could be an attractive alternative to more time-consuming enzyme-linked immunosorbent assays.
 
SQI Diagnostics’ platform consists of the SQiDworks automated workstation and QuantiSpot, a 96-well microarray consumable. Morris said that workstation users are typically able to process multiplexed assays to quantify serum concentrations of up to 12 individual biomarkers or qualitatively detect up to 24 biomarkers per patient.
 
SQI plans to seek 510(k) approval for the QuantiSpot Rheumatoid Panel, which combines ELISAs previously available for rheumatoid factors IgG, IgA, and IgM with anti-cyclic citrullinated peptide antibodies into one automated assay that it claims can yield “a conclusive diagnostic result.”
 
The company has not announced further details regarding the launch of its thrombosis panel, which will offer a multiplex test for beta 2 glycoprotein and cardiolipin markers each for IgG, IgA and IgM, respectively.

 
The complete version of this article appears in the current issue of BioArray News.

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