LAS VEGAS--(BUSINESS WIRE)--Research & Diagnostic Antibodies (R&D Antibodies) announced today it has been awarded a $2.6 million grant by the National Institute of General Medical Sciences (NIGMS), one of the National Institutes of Health (NIH). This 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 novel plasma biomarker discovered by R&D Antibodies that forecasts the onset of the sepsis pathology. In previous clinical studies this test was shown to differentiate patients with Systemic Inflammatory Response Syndrome (SIRS, also called pre-sepsis) who will develop sepsis from those SIRS patients who will not develop sepsis. 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 very early the progression from SIRS into sepsis and indicate the course of this life-threatening pathology. 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. This new test identifies those patients who will develop the sepsis pathology 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 (an FDA approved test for sepsis monitoring), 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.
“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,” said Dr. Robert Webber, Ph.D., President and CEO of R&D Antibodies. “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.”
About SIRS and Sepsis:
Sepsis is the No. 1 killer in hospital ICUs, and according to the Centers for Disease Control (CDC), has a mortality rate of 30%. It is estimated that sepsis causes 250,000 deaths annually in the United States and 750,000 worldwide, and it is well accepted that better clinical outcomes are achieved when treatment is begun immediately after diagnosis. The cost of treating septic patients in an ICU can add $5,000 or more per day to a patient’s bill, where treatment lasts at least two days and often more than 20 days. Since one in eight ICU patients are at risk for sepsis, the cost in the United States to treat sepsis exceeds $30 billion a year.
Several major healthcare systems have declared sepsis a major focus to improve the quality of care they provide to their patients and community. The early detection of SIRS (also called pre-sepsis) and sepsis is critical for patient survival, and further improvements will require earlier detection and better, more targeted therapy. This new blood test should also enable patient stratification and improved clinical trial design for the development of innovative new sepsis therapies, including aSeptiMab®, a chimeric human monoclonal antibody that specifically targets circulating iNOS that is currently in late stage preclinical development at R&D Antibodies. ASeptiMab® forms a “theragnostic pair” with the new IVD blood test.
About R&D Antibodies:
Research & Diagnostic Antibodies is a biotechnology company that develops new monoclonal antibodies for both diagnostic and therapeutic applications by identifying novel extracellular proteins as biomarkers for important diseases with unmet clinical need. R&D Antibodies’ strategy is to target significant clinical market opportunities and to be the first-in-class with novel diagnostics and companion monoclonal antibody therapeutics.