TORONTO, June 9 /CNW/ - SQI Diagnostics Inc. (TSX-Venture: SQD), a medical systems automation company focused on evolving laboratory-based biomarker testing, today announced that it has been awarded its ISO 13485:2003 certification for its quality management system for the Design and Development, Production, Distribution, Installation and Servicing of its In Vitro Diagnostics systems (Microarray Platforms and Consumable Kits). This significant milestone further reinforces SQI Diagnostics’ efforts to develop and manufacture high-quality medical systems and tests for the healthcare market.
“The certification and implementation of a Quality Management System in accordance with ISO 13485 demonstrates that we are well positioned to manufacture and distribute our SQiDworks(TM) platform and QuantiSpot(TM) panels at the standards required by our international customers,” said Claude Ricks, CEO of SQI Diagnostics. “This accomplishment brings us a step closer to commercialization of our first products. We expect to complete the validation studies of our automated microarray platform and multiplexed rheumatoid arthritis test panel in the coming months.”
ISO Certification
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to develop, manufacture and service medical devices that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
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 multi-analyte biomarker testing, allowing them to deliver patient results faster, using less labor, and fewer resources. SQI Diagnostics’ initial products target the autoimmune disease market, with initial products for rheumatoid arthritis and antiphospholipid syndrome scheduled for launch in 2008. SQI Diagnostics is based in Toronto, Canada. For further information please visit www.sqidiagnostics.com.
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.
For further information
Chief Financial Officer, Andrew Morris, (416) 674-9500 ext. 229, amorris@sqidiagnostics.com Investor Relations, James Smith, (416) 815-0700, ext. 229, jsmith@equicomgroup.com
Source: SQI Diagnostics Inc.
