Advance Early Detection of Lupus Nephritis with ClearGold

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Summary Systemic lupus erythematosus (SLE) or lupus is an autoimmune disease that impacts more than 5 million people worldwide, including 1.5 million Americans. Nearly 60% of these patients will develop lupus nephritis, which can cause kidney failure. As a result, its financial burden to individual patient can reach $70,000/year, much higher than many other diseases because of kidney transplantation. Although early treatment of lupus nephritis can significantly slow down or even prevent the disease progression to kidney failure, proteinuria, our current gold standard for screening lupus patients, is not sensitive and accurate enough for early detection of lupus nephritis. While new biomarkers or exogenous renal function markers are being developed or tested in clinical trials for early diagnosis of lupus nephritis, their sensitivity and accuracy are comparable to those of proteinuria. As a result, even today, proteinuria remains the gold standard and there are strong unmet needs for early detection and accurate monitoring of kidney damages in the lupus patients. To address this unmet need, ClearNano Inc. is developing a test agent, named “ClearGold” that can be used to detect lupus nephritis much earlier and more accurately than proteinuria. In this application, we aim to address two key questions: (1) How accurate this method is in detection of lupus nephritis; (2) How early this method can identify lupus nephritis in comparison with proteinuria in the mouse model. The success will validate the competitive advantages of ClearGold over proteinuria in the early detection of kidney damages in the lupus mouse model, which will lay down a solid foundation for clinical translation of “ClearGold”. Through these studies, we believe that a long-standing challenge in the early detection of kidney damages in the lupus nephritis can be eventually addressed with our “ClearGold” test agent, which represents a $1.6 Billion market opportunity.