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Press Releases

SQI Diagnostics Submits FDA 510(k) and Health Canada Medical Device License Filings

Released: Oct 29, 2008

Toronto, Canada, October 29, 2008 – SQI Diagnostics Inc. (TSX-Venture: SQD), a medical systems automation company focused on evolving laboratory-based biomarker testing, announced today that the United States Food and Drug Administration (FDA) has received the Company’s 510(k) submission. The 510(k) is seeking marketing clearance in the United States from the FDA for SQI’s automated SQiDworks™ platform and QuantiSpot RA™ microarray consumable test.

In addition, SQI has filed a Class II Medical Device License Application with Health Canada. Once approved, the Class II Medical Device License will permit the Company to market its automated SQiDworks Platform and QuantiSpot RA microarray consumable test in Canada.

"This is a significant milestone for SQI as it moves us one step closer to the commercial launch of our first products," said Claude Ricks, Chief Executive Officer of SQI. "During the past three weeks, we announced positive external validation test results for our automated platform, and appointed a seasoned expert in the sales and marketing of biomarker test platforms to spearhead our commercial launch.

Today’s regulatory actions are the final tasks we needed to complete to position SQI for revenue generation."

The SQiDworks automated platform is used to analyze multiple-biomarkers in a fully automated 'load-and-go' process. The lead test for the platform is the QuantiSpot RA assay, which provides simultaneous analysis of four biomarkers commonly prescribed to aid in the diagnosis and monitoring of rheumatoid arthritis, including the anti-CCP-IgG marker that has been adopted rapidly over the last five years.

SQI expects that its automated technology will significantly improve upon the current industry standard methods for biomarker testing, which can be labour intensive and inefficient.

About SQiDworks
SQiDworks is a fully-automated fluidics workstation, scanner and analytical device used to process SQI Diagnostics proprietary QuantiSpot microarray test devices. The platform fully integrates all assay steps for hands-free work-flow and is compatible with standard lab automation systems. The platform is capable of processing up to 240 patient samples per run and when combined with the Company's QuantiSpot multiplexed tests can produce quantified determinations for up to 960 individual test results per hour resulting in significant laboratory efficiencies and cost-savings.

About QuantiSpot
The SQI Diagnostics microarray device, QuantiSpot, is a multiplexed assay consumable for use with the SQiDworks workstation. QuantiSpot tests are currently being developed for the detection and quantification of biomarkers used in the diagnosis of Autoimmune Disease, Infectious Disease and Allergic conditions, among others. Each of the 96 wells of the QuantiSpot device contains proprietary microarrays for duplicate antibody capture, in-sample calibration and redundant test controls. When combined with the SQiDworks fully-automated workstation, users are able to process multiplexed assays to quantify serum concentrations of up to 12 individual biomarkers or the qualitative detection of up to 24 biomarkers per patient.

About SQI Diagnostics
SQI Diagnostics is a medical systems automation company focused on evolving laboratory-based biomarker testing. Using automation and proprietary miniaturization technologies, SQI Diagnostics significantly improves the economies of scale for laboratories performing multiple biomarker testing at high volumes, allowing them to deliver patient results faster using less labour and fewer resources. SQI Diagnostics' platform has a user-friendly interface, high sample throughput and offers a more efficient alternative to current testing options. SQI Diagnostics' initial products target the $1.4 billion autoimmune disease market, with initial products for rheumatoid arthritis and thrombosis scheduled for launch in 2008. SQI Diagnostics is based in Toronto, Canada. For further information please visit www.sqidiagnostics.com.

For further information please contact:

Certain information in this press release is based on beliefs and assumptions of the Company's senior management and information currently available to it that may constitute forward-looking information within the meaning of securities laws. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks and uncertainties. Actual results, events, and performance may differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements.

This release was prepared by management of the Company who takes full responsibility for its contents. The TSX Venture Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this news release.