Updated on 27 July 2012
Japan Patent Office gives Notice of Allowance for sepsis detection products
Singapore: Research & Diagnostic Antibodies (R&D Antibodies) received a notice of allowance from the Japan Patent Office (JPO) for its monoclonal antibody-based immunoassays and apparatuses for measuring inducible nitric oxide synthase (iNOS) as a plasma biomarker for the early detection of the sepsis pathology. The JPO's allowance extends the company's existing patent portfolio in this field, which presently comprises of contries such as US, European, and Australia, with several additional patents still in the pending stage.
Plasma iNOS is the foundation of R&D Antibodies' sepsis prognosis and monitoring tests that reveal very early the onset of the sepsis pathology. Until date R&D Antibodies has conducted three clinical studies involving more than 295 ICU patients to demonstrate the utility of this new plasma biomarker.
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. Plasma iNOS as a biomarker was shown to predict accurately the onset of sepsis in more than 96% of the severely injured ICU patients studied.
The last two clinical studies were partially funded by research grants awarded by the National Institutes of Health (NIH) after thorough peer review. R&D Antibodies is currently working on a $2.6 million grant awarded by the National Institute of General Medical Sciences to conduct a pivotal clinical study which should generate the data required to obtain FDA marketing clearance for this new blood test.
Dr Robert Webber, president and CEO, R&D Antibodies, said that, "Detection of circulating iNOS has broad application in numerous clinical settings including ICUs, emergency rooms, rehabilitation facilities, nursing homes, and outpatient clinics, and should guide physicians to initiate treatment earlier in this life-threatening pathology leading to reduced mortality and morbidity for the patient and reducing the huge financial drain that sepsis, severe sepsis and septic shock impose upon the healthcare system."