New Test to Be Based on Blood Marker for Sepsis

Sepsis is the body's response to a blood-borne infection. Often, the inflammatory response spirals out of control leading to organ failure, septic shock, and death. The early signs of sepsis, such as fever and elevated white blood cell count, are unfortunately also common to many other conditions. Without sensitive and specific diagnostic tools, doctors may not be able to recognize sepsis until it has progressed to a severe, life-threatening stage.

Research & Diagnostic Antibodies (R&D Abs, Los Vegas, NV, USA) discovers and develops novel immunologic reagents for research and clinical applications. A test for sepsis is the company's most advanced clinical project and is based on its patented iNOS monoclonal antibodies.

"It is my hope that iNOS will enable early diagnosis and management of patients at risk for sepsis. Our clinical trial data demonstrates that iNOS could be an important early marker for the onset of sepsis,” said Robert Webber, Ph.D., president and founder of R&D Abs.

Beckman Coulter, Inc. (Fullerton, CA, USA; www.beckmancoulter.com) has announced an exclusive licensing agreement with R&D Abs for the company's iNOS monoclonal antibodies and patents. Based on these, Beckman Coulter intends to develop iNOS tests for use on all its Access systems, including the Synchron Lxi 725 chemistry-immunoassay system and the high throughput UniCel DxI 800 immunoassay system. Beckman Coulter says it hopes to introduce the new tests in 2005.

"The manufacture, sales, and distribution of a new marker for sepsis can provide a diagnostic tool for a disease that is severely underserved,” noted Mike Whelan, vice president of Beckman Coulter's immunoassays and nucleic acid testing business center. "The licensing and development of this important analyte will be another milestone in the rapid expansion of our immunoassay menu with ‘best of breed' assays for the management of disease.”

According to the Society of Critical Care Medicine, sepsis kills more Americans than breast cancer, colorectal cancer, pancreatic cancer, and prostate cancer combined, and it affects more than 10% of the 14 million patients annually treated in intensive care units in U.S. hospitals. Of these, about 250,000 dies of sepsis despite aggressive and expensive treatments.

R&D Abs is now developing additional clinical tests for other diseases using human iNOS as a specific biomarker of disease. The company also has ongoing projects to identify other unique markers of disease based on its proprietary technologies.




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