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CHARLOTTESVILLE, Va. , March 1, 2023 /PRNewswire/ — AMPEL BioSolutions today announced a genomic precision medicine test for chronic kidney diseases, such as Lupus Nephritis, that could save lives by predicting kidney damage before it is irreversible and providing decision support for prophylactic therapies. Genes that drive the inflammatory pathways characteristic of different stages of kidney damage are revealed in the peer-reviewed journal Frontiers in Immunology. AMPEL’s breakthrough approach identified markers in kidney biopsy samples that drive pathways that can be targeted by drugs. The NephroGENE® lab test, only a concept for the last few years, is now ready for development for practical use as a decision support biomarker test to manage kidney disease.
AMPEL’s innovation is crucial to provide decision support for day-to-day patient care as well as effective drug development. Currently, physicians rely on microscopic examination of kidney biopsies to assess the severity of disease and there is no current way to predict drug options. Today’s publication identifies the molecular pathways at every stage of damage leading to end stage renal disease as well as targets of medications to slow down the immune driven damage. And translation of key genes in animal models used for Lupus Nephritis drug development with human patients is essential to increase the success rate of clinical trials and provide earlier confirmation of the applicability of pre-clinical work to human disease.
Working with colleagues at UVA and Virginia Tech , AMPEL found unique gene signatures for stages of kidney disease. In both these studies, AMPEL’s Genomic Platform allowed the breakthrough connection between human lupus nephritis and several mouse models of Lupus Nephritis used by Pharma for drug development. The team effort of two Virginia university mouse labs and the bioinformatics group at AMPEL BioSolutions has accelerated the commercialization of precision medicine testing for Lupus patients, addressing the unmet need of getting the right drug to the right person at the right time. The importance of decision support is emphasized by the observation that it takes five years on average, if ever, for a Lupus Nephritis patient to be prescribed medications that stabilize disease activity and reduce flares.
NephroGENE®‘s initial focus is slowing patient progression to kidney failure that requires dialysis and transplantation but the test can be used for the 40-60% of Lupus patients diagnosed with nephritis every year, many of whom are young with an average age of thirty. Kidney involvement happens more often in women of color for a variety of reasons including genetics and health disparities. According to the Johns Hopkins Lupus Center, a major challenge of lupus nephritis is that progression to end stage renal disease occurs even when patients are on standard-of-care medications, many of which have significant side effects. And the Lupus Foundation of America notes that life-threatening flares in people with lupus nephritis were more frequent and severe compared to those without kidney involvement.
One application of NephroGENE® is to assist the pharmaceutical companies who have 45+ drugs in development for Lupus Nephritis and face the challenge of enrolling patients in clinical trials that have the best potential to respond to the treatment being tested. Enrolling the “wrong” patients can result in trial failure, often leading to cancellation of a drug’s development towards FDA approval that may have benefit in a sub-group of the overall patient population. AMPEL’s technology helps pharmaceutical companies connect mouse models to human disease and proactively identify the patients most likely to respond to specific treatments, thereby helping improve outcomes in clinical trials and quality of life for patients in need.