NephroSant™ a biotechnology company dedicated to accelerating the diagnosis of early kidney damage in native and transplanted kidneys, with a mission to significantly improve global kidney health, announced that the Journal of Clinical Medicine has published real-world data (RWD) that provides insight into how changes in allograft health are reflected in specific ranges of QSant™ scores. QSant is a non-invasive home collection that analyzes biomarkers of kidney transplant rejection in urine and provides a score from 0-100 that can inform treatment decisions.
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“We developed QSant to aid physicians in the early detection of rejection in order to protect patients from an untimely loss of a transplanted kidney” explained NephroSant Founder, Minnie Sarwal, MD, PhD. “Results from this RWD study provide important insights for physicians when interpreting QSant scores. By understanding how these scores relate to a patient’s rejection risk, physicians can assess their patients’ evolving needs for immunomodulation throughout the continuum of their post-transplant care.”
Results from this RWD study of 235 adults and children who received kidney transplants at 11 U.S. transplant centers, show that QSant scores of <32 indicate stable immune quiescence. Importantly, not only does a score below 32 indicate the health of a patient’s kidney transplant, but it may negate the need for invasive biopsies. The study results identified a QSant Score of between 32 and 55 to indicate a state of alloimmunity flux. A decreasing gradient in this range may indicate a resolution of rejection following successful immunomodulation. In contrast, patients with an increasing gradient between 32 and 55 may be advancing towards an allograft rejection event. Lastly, a QSant score over 55 indicates histologically concordant acute rejection.
The open-access article, titled: “Through the looking glass: Unravelling the stage-shift of acute rejection in renal allografts” (doi.org/10.3390/jcm11040910) was published online in the peer-reviewed Journal of Clinical Medicine in February 2022.
NephroSant developed QSant as a Laboratory Developed Test (LDT), which is now covered by Medicare under a local coverage determination (LCD) issued by the Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostics Program (MolDX).