News ReleaseSpectral Diagnostics Inc. Quick Quote: T.SDI 2.80 (-0.17)
Spectral Diagnostics Inc. announces clearance to market the EAA in the European Union
9/10/03
TORONTO, Sep 10, 2003 /PRNewswire-FirstCall via COMTEX/ --
Spectral Diagnostics Inc. (TSX: SDI) today, announces receipt of notification and registration of a CE marking of conformity for its Endotoxin Activity Assay (EAA), as an aid in risk assessment of patients in the ICU for developing severe sepsis. The completion of a CE marking of conformity, along with Spectral's ISO 9001 and ISO 13485 certification allows the company to legally market the EAA in the European Union (EU) immediately, as well as after the full implementation of the In Vitro Diagnostics Directive (IVDD) in December 2003.
'This represents another important regulatory clearance for the EAA,' stated Spectral's President and CEO, Dr. Paul M. Walker. 'The EAA has previously been granted regulatory clearance for marketing in both Canada (TPD) and U.S. (FDA). The availability of this test system fills a very large unmet medical need for the rapid recognition of risk for developing sepsis, because early initiation of treatment for sepsis in the ICU has been shown to significantly reduce mortality. Over 5 million patients are admitted to ICUs in North America and Europe annually, and risk stratification for developing sepsis continues to be a significant concern,'stated Dr. Walker.
Spectral is a developer of innovative technologies for comprehensive disease management. Spectral provides accurate and timely information to clinicians enabling the early initiation of appropriate and targeted therapy. Current products are rapid format tests measuring markers of myocardial infarction (Cardiac STATus(R) test.) New products include rapid diagnostics for infection (the Endotoxin Activity Assay.) The EAA and Cardiac STATus(R) products are manufactured by Spectral Diagnostics Inc. Spectral's common shares are listed on the Toronto Stock Exchange: SDI.
This press release contains certain forward-looking statements and information based on beliefs of the Company's senior management as well as assumptions made by, and information currently available to it. 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, which speak only as of the date hereof.
SOURCE Spectral Diagnostics Inc.
At: Spectral Diagnostics Inc. - Dr. Paul M. Walker, Chief Executive Officer, (416) 626-3233 (SDI.)