JOINTstat™ – Expanding the Impact
Expanded Use Indications
JOINTstat™, a clinically game-changing blood test for Rheumatoid Arthritis (RA), now has expanded use indications in Canada and the EU. This novel test, which measures a protein called 14-3-3η, was first indicated for diagnostic use in RA. Further studies now demonstrate that levels of this protein inform both joint damage prognosis and monitoring. Since the protein is involved in joint destruction, elevated levels indicate higher risk of radiographic progression, and decreasing levels over time indicate abatement of destructive biological processes and support an improved prognosis for the patient.
It is widely accepted that, enabled by prompt diagnosis and referral, RA treatment with tight control towards clinical and joint damage remission can dramatically improve patient outcomes and overall system costs. In addition to assisting with early diagnosis, JOINTstat™’s expanded indications support treat-to-target objectives by allowing close monitoring of 14-3-3η levels along the clinical management path to inform how active the joint damage processes are. Please see the following link to access a recent JOINTstat™ article featured in the National Post on June 26.
Japanese Market Entry
The 14-3-3η blood test has been in use in the US since 2013 through an agreement with Quest Diagnostics. It was launched in Canada in December 2014 as JOINTstat™ by LifeLabs Medical Laboratories and the IVD kit is CE marked for commercial sale in the EU.
Augurex is proud to announce its third commercial agreement for JOINTstat™, represented by entry into the Japanese market with Medical & Biological Laboratories Co. Ltd (MBL), a leading provider of autoimmune diagnostic tests in Japan and an active research collaborator of Augurex since 2012. MBL’s growing focus on innovative products to improve clinical outcomes positions them well to make JOINTstat™ widely available to clinicians and their patients in Japan. We expect MBL to deliver the same consistent value to patients and clinicians that Augurex has seen through its commercial relationships with Quest Diagnostics and LifeLabs.
JOINTstat™ Pipeline Advancement
The novelty of 14-3-3η’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. Since 14-3-3η normally resides inside of cells in healthy people, when it gets outside of the cell in RA, the body views it as foreign and mounts an immune response in an attempt to clear the protein. This specific 14-3-3η auto-antibody response is also measurable in blood and adds important diagnostic sensitivity by capturing 90% of early RA patients. A recent study evaluating 500 subjects has published describing this dual JOINTstat™ test, which will achieve an unprecedented early RA capture rate to further enable prompt diagnosis and treatment, for improved outcomes. The new combined test is being readied by Augurex for clinical use in late 2016, early 2017.