SAN FRANCISCO – March 15, 2022 – NephroSant™, Inc. a biotechnology company dedicated to accelerating the assessment of early kidney damage with a mission to significantly improve global kidney health, announced the first patient has been enrolled into the Assessment of QSant™ for Underlying Allograft Rejection (AQUA) study. Eligible participants will have undergone kidney transplant within 90 days of enrollment. Up to 2,000 individuals are being enrolled and followed for 24 months, during which time they will be assessed for signs of acute rejection through QSant testing as well as standard-of-care diagnostics.
Minnie Sarwal, MD, NephroSant’s founder, explained, “historically, it has been incredibly challenging to monitor the health of a kidney transplant recipient. Their alloimmunity can fluctuate rapidly, especially during the first few weeks following surgery. These fluctuations, which may signal an increasing risk of a rejection event, can be missed by a routine biopsy, or may evolve into an acute event between scheduled biopsies. A test like QSant has the potential to improve long-term outcomes through the accurate prediction of rejection events.”
During the 24-month study period, the number of biopsies, rejection events and hospitalizations as well as changes in medication for each participant will be recorded. Following the conclusion of the study, these metrics will be compared to those of a retrospective, site-matched cohort of kidney transplant recipients to demonstrate QSant performance in comparison to standard-of-care for detecting and facilitating early intervention of acute transplant rejection events.
“We expect the AQUA Study will provide important quantitative evidence of the benefits of QSant in terms of a reduced risk of transplant rejection and reduced reliance on invasive biopsies,” added Francisco Dias Lourenco, NephroSant’s SVP of product and operations. “We are working with investigators at over 25 centers of excellence and look forward to bringing on new sites throughout 2022.”
NephroSant developed QSant as a Laboratory Developed Test (LDT), which is covered by Medicare under a local coverage determination (LCD) issued by the Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostics Program (MolDX).
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. Among these, 785,000 people have kidney failure and require either dialysis or a kidney transplant to survive. Kidney transplants are performed in 22,400 people each year. 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, yet approximately 40% of all kidney transplant recipients experience clinical or sub-clinical rejection. Monitoring for allograft rejection is required through the lifetime of the transplant.
QSant is the first 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 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, a QSant collection kit 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.
NephroSant is dedicated to all aspects of kidney health. The company was founded by Dr. Minnie Sarwal, a physician with deep scientific insight into kidney disease and transplantation. Together with a team of world-class scientists, engineers, and clinicians, NephroSant licensed the founding team’s clinical research and used it to develop a non-invasive diagnostic test to address the hidden epidemic of chronic kidney disease. Nephrosant is dedicated to improving global kidney health through a growing pipeline of products including QSant, the company’s flagship diagnostic test. To learn more, visit nephrosant.com.
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