Quest Diagnostics and Augurex Life Sciences inked an exclusive license agreement centered on the development of a clinical laboratory-developed testing service for the U.S. market based on Augurex’s 14-3-3η protein rheumatoid arthritis (RA) biomarker. Quest expects to launch the service during 2013. Augurex says it also plans to instigate regional 14-3-3η agreements with commercial laboratories in other territories, including the EU, Asia, and Canada.

14-3-3η is normally an intracellular protein, but in arthritis patients the protein is released into the joints and is involved in the processes that cause joint tissue breakdown. Augurex claims that because the protein is also detectable in the blood it represents both a drug target and biomarker that can be used to follow disease progression through a simple blood test, or for development as a companion diagnostic to identify patients who are responding to therapy.

“The real focus in RA these days is to ensure that patients are identified, ideally early in the course of disease, so that they can get on appropriate treatments that may significantly improve their short- and long-term outcome,” comments Walter Maksymowych, co-discoverer of 14-3-3η, who is Medical Research Professor of Medicine and Rheumatology at the University of Alberta, Canada. “New data suggests that blood testing for 14-3-3η could assist in identifying patients whose diagnosis may otherwise have been delayed.”

Augurex is undertaking multiple research programs investigating related forms and functions of 14-3-3η that may lead to the development of a biomarker panel for RA and other inflammatory conditions. The firm is also evaluating a series of anti-14-3-3η monoclonal antibodies as potential therapeutic candidates for RA. 

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