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.
“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).
About Chronic Kidney Disease and Transplantation
Chronic kidney disease (CKD) is a progressive process in which kidneys are damaged and lose their ability to filter waste, minerals and fluid from blood. Kidney disease affects an estimated 37 million people in the U.S. alone. 22,400 people receive kidney transplants each year, and an estimated 785,000 have kidney failure that require either dialysis or a kidney transplant to survive. Approximately 40% of all kidney transplant recipients experience clinical or sub-clinical rejection. Transplant recipients must be tested routinely and take anti-rejection medication for the rest of their lives to ensure the longevity of the transplanted organ. Monitoring for allograft rejection is required through the lifetime of the transplant.
QSant is the first truly non-invasive diagnostic test designed to detect kidney transplant rejection risk eliminating the need to always travel to a medical center for a costly and invasive biopsy. This test screens urine against a panel of 6 biomarkers, including but not restricted to urine cell-free DNA, to alert the patient and their care team to an increasing rejection risk so physicians can intervene in a timely manner. Analysis is conducted in a laboratory certified under a CLIA license to perform high-complexity testing. Centers for Medicare & Medicaid Services (CMS) issued a Local Coverage Determination (LCD) in July 2021. Interested parties may view the LCD on the CMS website.
When ordered by a treating physician, QSant is shipped directly to the patient’s home. A single urine sample is collected and shipped back directly to the NephroSant lab for analysis. NephroSant’s proprietary algorithm generates a personalized “Q-Score™,” which quantifies risk of rejection personalized to a particular patient. This score is delivered directly to the physician to inform post-transplant care. QSant has been studied through NephroSant’s Early Access Program (EAP) conducted within a select group of 11 transplant centers in the US. Feedback from physicians and patients surveyed during the EAP supports QSant’s accuracy for rejection detection, ease of use and convenient in-home collection.