Spectral’s EAA™ Endotoxin Activity Assay is the only FDA cleared, CE marked rapid diagnostic for endotoxemia. 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.
Highly sensitive and specific, the EAA™ has a rapid turnaround time of only 30 minutes allowing clinicians to quickly determine the level of endotoxin, a deadly component of all gram negative bacteria, in a patient’s bloodstream.
The EAA™ received FDA clearance in 2003 following the MEDIC (Multi-Center Endotoxin Detection in Critical Illness) clinical trial, which was conducted in intensive care units throughout North America and Europe. Spectral demonstrated in this trial that higher EAA™ levels are correlated with a higher risk of mortality, as well as an increasing risk for developing sepsis. This is significant and actionable information to guide and monitor the use of anti-endotoxin strategies, such as Toraymyxin, a therapeutic hemoperfusion device that removes endotoxin from the bloodstream. Patients with sepsis and high EAA™ levels are most likely to benefit from Toraymyxin. The EAA™ will be employed to direct the use of the Toraymyxin column in the first ever theranostics trial in the area of sepsis, the EUPHRATES trial, which is currently recruiting in the U.S.
Together, the combined diagnostic of EAA™ and therapeutic of Toraymyxin has the potential to provide a more effective treatment for patients with endotoxemia.