EAA™ Endotoxin Activity Assay

Theranostics: Combining unique diagnostics followed by a targeted therapy


EAA™ and PMX are licensed and available for use in Canada. PMX is not approved for clinical use in the USA, and is currently undergoing the PMA (Premarket approval) process. EAA™ is FDA cleared for use in the USA. The information presented herein is region specific. Please contact Spectral Medical Inc. at info@spectraldx.com to obtain appropriate product information for your country.

Spectral’s EAA™ Endotoxin Activity Assay is the only Health Canada licensed, FDA cleared, and CE marked rapid diagnostic for endotoxin activity in human whole blood. Endotoxin is an early objective marker for severity of sepsis that may not be identified with traditional clinical signs. Endotoxin is the most important microbial mediator of sepsis, yet, until the EAA™, there has been no reliable method to measure it accurately in the blood stream.

The EAA™ received FDA clearance in 2003 following the MEDIC (Multi-Center Endotoxin Detection in Critical Illness) clinical trial, demonstrating that higher EAA™ levels are correlated with a higher risk of mortality, as well as an increasing risk for developing sepsis. The EUPHRATES trial demonstrated that EAA™ can be used as a diagnostic to drive anti-endotoxin therapy (PMX, Toraymyxin Hemoperfusion) in septic shock patients.

Aside from its approved clinical use, EAA™ is becoming the gold standard for the measurement of endotoxin (LPS) activity, and is commonly utilized in various research studies focused on the role of endotoxin in disease development in both human and animal models.

Exploring Endotoxin:

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