Augurex Life Sciences Corp. has signed an exclusive license agreement with Quest Diagnostics, for the development of a clinical laboratory-developed testing service for the US market, based on Augurex's rheumatoid arthritis (RA) 14-3-3 η biomarker. Quest Diagnostics expects to launch the service in 2013. Additional terms were not disclosed.

"Augurex's business model is to advance early-stage biomarkers by demonstrating their clinical utility and collaborating with companies, such as Quest Diagnostics, with the expertise and infrastructure to develop their potential as clinically useful tests broadly accessible by clinicians and patients," says Norma Biln, chief executive officer of Augurex.

In addition to the agreement with Quest Diagnostics for the US market, Augurex intends to form regional 14-3-3 η agreements with commercial laboratories outside the United States, including in the European Union, Asia and Canada.

Early diagnosis and treatment of RA is associated with more favourable outcomes than late-stage diagnosis. The 14-3-3 η marker is a protein that is elevated in the blood of patients with RA that is relatively absent in healthy people and those with other types of auto-immune conditions. 14-3-3 η appears to be even more elevated in patients with RA or Psoriatic Arthritis (PsA) who have joint damage. Data presented over the past two years at international conferences such as the American College of Rheumatology (ACR) Annual Scientific Meeting and European League Against Rheumatism (EULAR) Conference describe the clinical usefulness of assessing 14-3-3 η blood levels with currently available markers, such as RF and anti-CCP for earlier RA diagnosis, and with CRP, to profile parameters such as joint damage and response to therapy in RA and PsA.

"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. New data suggests that blood testing for 14-3-3 η could assist in identifying patients whose diagnosis may have otherwise been delayed," says Dr Walter Maksymowych, co-inventor of 14-3-3 η, the principal investigator of several 14-3-3 η studies and Medical Research Professor of Medicine and Rheumatologist at the University of Alberta, Canada.

Augurex has multiple research programmes investigating related forms and functions of 14-3-3 η which may collectively constitute a biomarker panel to further inform RA and other inflammatory conditions. In addition to its utility as a blood test, data has been presented that describes the 14-3-3 η protein as a contributor to the disease and that blocking it with drugs may serve as a novel therapeutic approach to treating patients with RA.

"14-3-3 η creates the exciting possibility of personalized medicine in RA, whereby you block the protein with drugs and measure the success of your intervention by monitoring the levels of the 14-3-3 η through a blood test," says Dr Mark Genovese, Professor of Medicine, Immunology and Rheumatology at Stanford University Medical School.

Quest Diagnostics is the world's leading diagnostic testing company, and serves approximately half of the physicians and hospitals in the United States.