R&D Antibodies LLC aims to capture a significant fraction of a $1.6 billion per year clinical IVD test market for sepsis and severe sepsis based upon new enabling technologies it has discovered, developed and patented. These first-in-class technologies have led to unique new clinical products to meet existing underserved market needs for rapid, accurate diagnostic tests for the early detection of sepsis and severe sepsis.

The mission of R&D Ab® is to commercialize the first rapid diagnostic test that is able to predict early the onset of sepsis and that can be used to monitor the course of the pathology. R&D Ab® also intends to expand its unique iNOS diagnostic tests to other inflammatory disorders. Hospital-acquired infections (nosocomial infections) are preventable adverse patient events that affect approximately 2 million people in the U.S.A. every year. Sepsis is the leading cause of mortality in hospital Intensive Care Units (ICUs). Each year, at least 25 million people worldwide enter into the early stages of sepsis which results in more than 5.6 million deaths per year.

Sepsis is often thought of as an infection, but it is not an infection. The sepsis pathology results from an individual person’s system-wide response to an infection, which poses life-threatening risk of organ damage, dysfunction, and death. With this insidious pathology, the body attacks itself. Micro-organisms, such as bacteria and fungi, can invade the body through wounds or IV lines, grow out of control, and initiate a hyperinflammatory response. Clinical studies have conclusively demonstrated plasma iNOS is a new biomarker that is specific for the sepsis pathology, is highly accurate, and appears very early in an episode of the pathology.

R&D Ab’s test for plasma iNOS can detect the onset of sepsis more than 24 hours earlier than the attending physicians can see the physiological symptoms associated with the pathology.

In the EU, this device cannot be marketed or put into service until it complies with the requirements of the IVD Directive (98/79/EC) and obtains a CE mark.

In the USA, “For Investigational Use Only” since the performance characteristics of this product have not been established.

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