European Patent Office to grant patent for R&D Antibodies’ immunoassays and apparatuses

Research & Diagnostic Antibodies LLC (R&D Antibodies) announced today that it has received a notification stating that the European Patent Office intends to grant a patent 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.

This notification is equivalent to a “Notice of Allowance” by the United States Patent Office. European patent application 01959345 covers very broadly the use of R&D Antibodies’ immunoassays, kits, and apparatuses for the detection of plasma iNOS as a biomarker for the prognosis and diagnosis of Systemic Inflammatory Response Syndrome (SIRS) that will deteriorate into sepsis. This European Patent Office allowance of claims extends R&D Antibodies’ existing patent portfolio in this field (USA #6531578-B1 and 7198904-B1, European #EP1012605, Japan #4117911, and Australian #2001280912 and 782922). Equivalent patent applications are also pending in the USA, Japan, Australia and Canada.

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 clinical studies involving more than 295 ICU patients using tests based upon its patented anti-iNOS monoclonal antibodies. The last two clinical studies were partially funded by research grants awarded by the National Institutes of Health (NIH) after thorough peer review. 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), plasma iNOS was found to be more specific than PCT and to be an earlier marker for the onset of the sepsis pathology. 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.

“This patent is a strong addition to our intellectual property portfolio and adds to our leadership position in the early detection of sepsis,” said Dr. Robert Webber, Ph.D., President and CEO of R&D Antibodies, and the lead inventor on the patent. “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 leading to reduced mortality and morbidity for the patient and reducing the huge financial drain that sepsis and severe sepsis impose upon the healthcare system.”