JOINTstat™ cleared for clinical use in Australia by the Therapeutic Goods Administration (TGA)
Augurex is pleased to announce that the JOINTstat™ (14-3-3η) blood test has been cleared for clinical use in Australia by the Therapeutic Goods Administration (TGA). The test is indicated for the diagnosis of rheumatoid arthritis (RA) and the assessment and monitoring of joint damage progression risk. Australia represents the fourth market that 14-3-3η has become available in since the test was launched in the US in late 2013. The JOINTstat™ test is available in Canada through LifeLabs and in Japan through MBL and is CE marked for European clinical use.
At the recent American College of Rheumatology (ACR) Annual Meeting, international investigators presented data in 12 studies that were delivered through poster or oral forums. A Canadian study in 331 subjects demonstrated that a positive 14-3-3η blood test in pre-RA, predicts and serially informs ongoing joint damage progression over 5 years. Even patients who achieved clinical remission at 18 months continued to have joint damage progression if their 14-3-3η blood levels remained or became positive over time. Catching RA early and treating to clinical and radiographic remission is paramount as the rheumatology community aims to stop this disease in its tracks. The 14-3-3η blood test enables early RA diagnosis and joint damage monitoring to achieve tight disease control for better outcomes. Another study at ACR described the protein’s harmful role in disease development wherein animals who were dosed with an anti-14-3-3η drug that binds the protein in blood, had a delayed onset and reduced severity of arthritis. Together these data underscore the precision medicine opportunity that a matched drug and blood test duo creates to tackle RA in a way that has never been possible before.
The novelty of this protein’s function in RA is generating a critical mass of data that support the multiple ways that 14-3-3η is improving the understanding of this debilitating disease. Japanese investigators recently published a study in 149 patients with established RA demonstrating that serum 14-3-3η levels and their serial measurements inform disease severity and clinical outcomes.
The 14-3-3η blood test helps doctors gain a viewpoint of the “damage mechanisms” underway in the patient’s body that may not be evident by clinical examination. For more information please visit the JOINTstat™ and or Augurex websites.