The renal transplant community is heavily reliant on serum creatinine levels as a trigger to diagnose acute rejection. However, serum creatinine is a late indicator of renal injury and exhibits high variability and high false positivity. These inadequacies lead to delayed diagnosis and irreversible renal damage.
As such, we developed the World’s first predictive test of acute rejection. This solid organ rejection test (SORT) accurately detects acute rejection 4 months prior to biopsy or other signs of clinical graft dysfunction. SORT will allow clinicians to circumvent acute rejection and increase the lifespan of transplanted organs by up to 9 years. SORT is intended to be utilized in conjunction with standard clinical assessment.
SORT will be available in select markets in Fall of 2012.
More than 120,000 renal allograft recipients in the United States experience frequent and prolonged comorbidities that result form sustained usage of immunosuppressants. This exposure is currently necessary due to the substantial risk of allograft rejection in the absence of clinically relevant tools to effectively monitor alloimmune quiescence, or renal tolerance.
We have developed and obtained the exclusive license for a minimally invasive blood test that accurately identifies alloimmune quiescence in kidney transplant patients. This spontaneous tolerance test (SPOT) is not influenced by the presence of immunosuppressants and will facilitate immunosuppression minimization in renal allograft recipients. We are currently performing SORT on prospectively collected samples from a large clinical trial prior to our public launch.
We have identified 8 biomarkers that accurately identify renal injury in the urine from more than 50 patients. We will update further following validation in larger patient cohorts.