QiSant™ Initial Publication Demonstrates Strong Clinical Validation of Urine-Based Assay in Kidney Transplant Surveillance
Science Translational Medicine published the study demonstrating the first evidence of the assay in kidney transplant from NephroSant, a Kidney Health spinout from UCSF, led by Dr. Minnie Sarwal
SAN FRANCISCO, March 18, 2020 (Newswire.com) - NephroSant, a startup company that is focused on redefining kidney health, today announced the landmark publication showing high accuracy for a urine-based assay for the surveillance of kidney transplant patients to identify rejection.
The study was published in Science Translational Medicine and demonstrates the assay, called QiSant, can successfully identify both types of rejection - t-cell mediated rejection (TCMR) and antibody mediated rejection (ABMR) - in over 600 patients with accuracy over 95%. The study also showed the ability of QiSant to predict rejection episodes up to 200 days before a biopsy-confirmed rejection. Finally, the test showed the ability to identify rejection in adult and pediatric populations, as well as re-transplants.
“The ability to detect rejection with high sensitivity and specificity from urine has the ability to transform the monitoring of kidney transplant patients,” said Dr. Minnie Sarwal, UCSF Professor in Residence in Surgery and Medicine and founder of NephroSant. “Up to 20% of kidney transplants each year are re-transplants. This underscores the need to maximize the success of future transplants by identifying rejection risk and manage patients in a more proactive way,” she added.
NephroSant has already published five scientific papers looking at the performance of the assay in other areas of kidney health, most notably in identifying Chronic Kidney Disease and recurrence of kidney stones.
The study titled “A Urine Score for Non-Invasive Accurate Diagnosis and Prediction of Kidney Transplant Rejection” can be found here: https://stm.sciencemag.org/content/12/535/eaba2501
NephroSant’s first product is QiSant™, which is designed specifically for the detection of kidney transplant rejection. The multi-biomarker QiSant™ test generates quantitative test results from a standard urine sample and will be marketed as a laboratory developed test (LDT) service through NephroSant’s CLIA certified laboratory directly to hospitals and clinics caring for kidney transplant patients.
NephroSant was founded in November 2017 by Dr. Minnie M. Sarwal, a nephrologist, a researcher of transplant immunology and a serial entrepreneur, as a spinout of her UCSF laboratory. Dr. Sarwal founded NephroSant with a mission to provide noninvasive testing solutions to assess, manage and improve global kidney health. NephroSant plans to build on Dr. Sarwal’s existing clinical research and develop centralized lab tests and point-of-care tests for kidney diseases and allograft monitoring for other organs.
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