Spectral Diagnostics announces receipt of final FDA clearance to market EAA
TORONTO, June 18 /CNW/ - Spectral Diagnostics Inc. (TSX: SDI) today,
announces receipt of final notification of market clearance in U.S. for its
Endotoxin Activity Assay (EAA), an aid in risk assessment of patients in the
ICU for developing severe sepsis.
"This represents a major step forward for our Company," stated Spectral's
President and CEO, Dr. Paul M. Walker. "The Endotoxin Activity Assay fills a
very large unmet medical need. Early initiation of treatment for sepsis in the
ICU has been shown to significantly reduce mortality. Results of the EAA are
available within an hour, in comparison with microbial cultures, which can
take 24-72 hours to produce results. 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," added Dr. Walker.
The uniqueness of the assay is demonstrated by the approval process,
which first determined that the EAA was both safe and effective, and then
directed it to be listed with U.S. Federal Registry as the standard method for
endotoxin analysis. Any other assays for endotoxin will require pre-market
notification and will be assessed against the Special Controls Guidance
Document identifying the EAA as the standard.
Spectral developed the EAA under a joint venture between Sepsis Inc., a
subsidiary of Spectral, and Elan International Services, Ltd., a subsidiary of
Elan PLC.
Upon FDA approval of the EAA, Sepsis Inc. is potentially eligible for a
milestone payment, should Elan elect to proceed with commercialization.
Spectral and Elan are in discussions regarding the commercialization of the
EAA.
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 sepsis (the Endotoxin Activity Assay). Spectral Diagnostics Inc.
manufactures the EAA and Cardiac STATus(R) products. Spectral's common shares
are listed on the Toronto Stock Exchange: SDI. |
