Research & Diagnostic Antibodies (R&D Antibodies) has been awarded a $2.6m grant by the National Institute of General Medical Sciences (NIGMS), one of the National Institutes of Health (NIH). The award will partially fund a pivotal clinical study designed to obtain FDA marketing clearance for a new in vitro diagnostic (IVD) test.
The new test is based upon a plasma biomarker discovered by R&D Antibodies that forecasts the onset of the sepsis pathology. In previous clinical studies the test was shown to differentiate patients with Systemic Inflammatory Response Syndrome (SIRS, also called pre-sepsis) developing sepsis from the SIRS patients without sepsis.
R&D Antibodies said that the results obtained from the iNOS test will allow physicians to treat their patients more effectively by starting antibiotic treatment and fluid resuscitation sooner.
Plasma iNOS is the foundation of R&D Antibodies’ SIRS prognosis and monitoring tests that reveal early the progression from SIRS into sepsis and indicate the course of this life-threatening pathology.
Reportedly, R&D Antibodies has conducted three previous clinical studies, also partially funded by research grants awarded by the NIGMS, involving more than 290 ICU patients using tests based upon its patented anti-iNOS monoclonal antibodies. Plasma iNOS has been found to be a specific, accurate and reliable biomarker for detecting very early the onset of sepsis.
The new test identifies the patients with the sepsis pathology in 24-48 hours prior to the appearance of the physiological symptoms currently used by physicians as indictors of the onset of sepsis. In a direct comparison with the Procalcitonin test (PCT), plasma iNOS was found to be more specific than PCT and to be an earlier marker for the onset of the sepsis pathology.
As a biomarker, plasma iNOS was shown to predict accurately the onset of sepsis in more than 96% of the severely injured ICU patients studied.
Robert Webber, president and CEO of R&D Antibodies, said: “This award will allow us to complete this phase of clinical testing, obtain FDA clearance and ready this critically needed new test for launch onto the clinical lab market. Detection of circulating iNOS has broad application in numerous clinical settings, including ICUs, emergency rooms, rehabilitation facilities and outpatient clinics, and should guide physicians to initiate treatment earlier in this life-threatening pathology.
“Early treatment should reduce patient mortality and morbidity and ease the huge financial drain that sepsis imposes upon the healthcare system.”