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TORONTO, April 9 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc. today announced that its Endotoxin Activity Assay (EAA(TM)), an FDA cleared diagnostic for risk of sepsis, will be used to measure endotoxin levels during the enrolment of patients in a Phase III sub study, part of a multinational clinical trial evaluating the safety and effectiveness of a treatment for severe sepsis.
“Spectral is pleased that a major international pharmaceutical company is using the EAA(TM) in a proportion of patients in its study,” said Dr. Paul Walker, President and CEO of Spectral Diagnostics. “We are optimistic that the data from this sub study will promote subsequent use of the EAA(TM) to identify patients most likely to benefit from specific anti-endotoxin therapy.”
Currently, in North America, there is no available drug to directly counter the effects of endotoxin. The Phase III sub study will explore the utility of partnering a reliable measurement of endotoxin, the EAA(TM), with a targeted anti-endotoxin treatment aimed at reducing mortality rates for patients with severe sepsis. Spectral’s unique assay helps identify endotoxin levels in patients and enables appropriate and rapid application of therapeutics.
Spectral has a contractual agreement to supply EAA(TM) equipment, test kits and technical expertise for use in the study that is expected to run until mid 2010.
About Spectral Diagnostics
Spectral is a developer of innovative technologies for comprehensive disease management. Spectral’s lead product is its EAA(TM) Endotoxin Activity Assay, the only FDA approved diagnostic for the measurement of endotoxin. Spectral technologies provide accurate and timely information to clinicians enabling the early initiation of appropriate and targeted therapy. Spectral is listed on TSX under the symbol SDI.
Forward-looking statement
Information in this news release that is not current or historical factual information may constitute forward-looking information within the meaning of securities laws. Implicit in this information, particularly in respect of the future outlook of Spectral and anticipated events or results, are assumptions based on beliefs of Spectral’s senior management as well as information currently available to it. While these assumptions were considered reasonable by Spectral at the time of preparation, they may prove to be incorrect. Readers are cautioned that actual results are subject to a number of risks and uncertainties, including the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Spectral to take advantage of business opportunities in the biomedical industry, the granting of necessary approvals by regulatory authorities as well as general economic, market and business conditions, and could differ materially from what is currently expected.
The TSX has not reviewed and does not accept responsibility for the
adequacy or accuracy of this statement.
CONTACT: Dr. Paul Walker, President & CEO, (416) 626-3233 ex. 2100; James
Smith, Investor Relations, (416) 815-0700 ext. 229, jsmith@equicomgroup.com
