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 Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostics Program (MolDX) has issued a local coverage determination (LCD) for the use of QSant™. QSant is the first available product to deliver accurate identification of kidney transplant rejection risk from a non-timed urine sample that can be collected in the comfort of a patient's home.
QSant provides a numerical risk Q-Score™ for rejection detection and rejection severity. The Q-Score is computed by artificial intelligence, which measures urine analytes for early signals of rejection. By so doing, QSant provides a new clinical tool to detect post-transplant rejection in advance of a rejection event, allowing physicians to adjust a patient's immunosuppression titration promptly, without always requiring the confirmation of an invasive blood test or biopsy.
"The favorable evaluation of our data by MolDX and their ultimate coverage decision is a significant milestone for NephroSant and will enable us to get this powerful tool into the hands of providers," noted Dr. Minnie Sarwal, Nephrosant founder and professor of surgery at UC San Francisco (UCSF). "The early detection of transplant rejection is expected to be game changing for patients and represents an important step towards improving the health and longevity of transplanted kidneys."
Gina Ford, chief commercial officer of NephroSant added, "We believe QSant has the potential to improve post-transplant patient care by giving nephrologists the information they need to act proactively months in advance of a rejection event. We look forward to introducing the only urine-based, 6-biomarker kidney rejection test, as an at-home, non-invasive test for patients in the coming months."
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 home-based diagnostic test designed to detect kidney transplant rejection up to 8 months prior to rejection from a single urine sample, 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 August 2021, which covers the cost of the test for eligible transplant recipients on Medicare. 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. During development, more than 1,000 patient samples were analyzed using QSant and the clinical and analytical validation of the test published in the Journal of Science and Translational Medicine.
QSant has been studied through NephroSant's Early Access Program (EAP) conducted within a select group of 10 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 UCSF 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 best-in-class, non-invasive diagnostic tests 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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