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Spectral';;s Endotoxin Activity Assay featured in major publication

^{Published on 2011-09-28 11:52:13 - Market Wire}
 

TORONTO, Sept. 28, 2011 /CNW/ - Spectral Diagnostics Inc., (TSX: SDI), a Phase III company developing the first theranostic treatment for patients with septic shock, today announced the publication of a study utilizing Spectral's Endotoxin Activity Assay (EAA™ ) to identify children at high risk of complications from open heart surgery.

The study, which is published in the online version of the American Journal of Respiratory and Critical Care Medicine (AJRCCM), showed that intestinal injury, endotoxaemia and activation of endotoxin signaling pathways are prevalent in children with congenital heart disease. In addition, the study, authored by Dr. Nazima Pathan and her group of investigators from Imperial College of London and several other prominent institutes in the United Kingdom, concluded that endotoxin activity correlates with a number of outcome variables in this population, and may be used to guide the use of gut-protective strategies.

"The AJRCCM is the highest-impact journal in the field of critical care," said Dr. Paul Walker, CEO of Spectral Diagnostics.  "This study demonstrates the important role endotoxin can play in many different disease states. The better understanding of the mechanisms for translocation of endotoxin discovered in this manuscript lends support to our EUPHRATES trial design in sepsis. We are especially pleased that the EAA is being tested by sophisticated research groups like Dr. Pathan's to help identify other potential populations for future research on targeting endotoxemia to improve patient outcomes."

About 35,000 infants (1 out of every 125 children) are born in the United States each year with some form of congenital heart defect. Many of these children go on to require open heart surgery. 

About Spectral Diagnostics

Spectral is a Phase III company seeking U.S. FDA approval for its lead theranostics product for the treatment for severe sepsis and septic shock. Toraymyxin is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream. Directed by the Company's Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic for the risk of developing sepsis. Spectral's EUPHRATES trial is the world's first theranostics trial in the area of sepsis.

Toraymyxin has been approved for therapeutic use in Japan and Europe, and has been used safely and effectively in more than 80,000 patients to date. In March 2009, Spectral obtained the exclusive development and commercial rights in the U.S. for Toraymyxin, and in November 2010, signed an exclusive distribution agreement for this product in Canada. More than 250,000 patients are diagnosed with severe sepsis and septic shock in North America each year, representing a greater than $1 billion market opportunity for Spectral. Spectral is listed on the Toronto Stock Exchange under the symbol SDI. For further information please visit [ www.spectraldx.com ]

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.