NEW YORK (GenomeWeb News) – Research & Diagnostic Antibodies today said that it has received a $2.6 million grant from the National Institute of General Medical Sciences to support studies on its sepsis test.
The firm said that the funds would be used partly to support a pivotal clinical study designed to obtain US Food and Drug Administration clearance for its iNOS test, which is being developed to differentiate patients with Systemic Inflammatory Response Syndrome who develop sepsis from those who will not develop sepsis. The test is based on a novel plasma biomarker discovered by R&D Antibodies.
The Las Vegas-based company said that results from the iNOS test will enable physicians to treat patients more effectively by starting antibiotic treatment and fluid resuscitation sooner.
R&D Antibodies has conducted three previous clinical studies, also partially funded by NIGMS grants, involving more than 290 ICU patients using tests based on the anti-iNOS monoclonal antibodies. The company said that the new test can identify patients who will develop the sepsis pathology 24 to 48 hours prior to the appearance of the physiological symptoms currently used by physicians as indictors of the onset of sepsis.
"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," Robert Webber, president and CEO of R&D Antibodies, said in a statement. "Early treatment should reduce patient mortality and morbidity and ease the huge financial drain that sepsis imposes upon the healthcare system."
R&D Antibodies said that sepsis causes an estimated 250,000 deaths annually in the US and 750,000 worldwide. It also noted that the cost of treating septic patients in an intensive care unit can add $5,000 or more per day to a patient's bill.