JointStat, a blood test for rheumatoid arthritis (RA) developed by Augurex, Vancouver, British Columbia, now has expanded use indications in Canada and the European Union.

Measuring the 14-3-3? protein, the test was first indicated for diagnostic use in RA. Further studies now demonstrate that levels of the protein inform both joint damage prognosis and monitoring. Since the protein is involved in joint destruction, elevated levels indicate higher risk of radiographic progression; decreasing levels over time indicate abatement of destructive biological processes and may indicate an improved prognosis for the patient.

In addition to assisting with early diagnosis, JointStat’s expanded indications support treat-to-target objectives by enabling close monitoring of 14-3-3? levels along the clinical management path to detect how active the joint damage processes are.

The blood test has been in use in the United States since 2013 through an agreement with Quest Diagnostics, Madison, NJ. LifeLabs Medical Laboratories, Toronto, Ontario, launched the test in Canada in December 2014. Augurex recently finalized its third commercial agreement for the test, entering the Japanese market with Medical & Biological Laboratories Co Ltd, Nagoya, Japan. The in vitro diagnostics kit is CE marked for commercial sale in the European Union.

Augurex is now developing a dual JointStat test that aims to achieve an unprecedented early RA capture rate, in order to further enable prompt diagnosis and treatment for improved outcomes.

Specifically, the novelty of 14-3-3?’s expression outside of cells in the RA disease state, where it is measurable in blood, is the central pillar of the JointStat product portfolio. In healthy people, 14-3-3? normally resides inside cells. For those with RA, it moves outside the cell; the body views it as foreign and mounts an immune response in an attempt to clear the protein.

This 14-3-3? auto-antibody response is also measurable in blood, enabling the dual test to capture 90% of early RA patients. Augurex is developing the combined test for clinical use in late 2016 or early 2017.

For more information, visit Augurex.