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Submission seeking FDA Clearance of KidneyIntelX
Submission seeking FDA Clearance of KidneyIntelX.
About this update from Renalytix Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 1457X\n Renalytix AI PLC\n 26 August 2020\n \n \n \n \n Renalytix AI plc\n \n \n (\"RenalytixAI\", the \"Company\")\n \n \n \n \n \n RenalytixAI Files Submission Seeking U.S. FDA Clearance of KidneyIntelX\n \n \n \n \n \n \n \n \n \n NEW YORK, August 26, 2020\n \n - \n \n \n Renalytix AI plc\n \n \n (\n LSE: RENX) (NASDAQ: RNLX), an artificial intelligence-enabled in vitro diagnostics company, focused on optimizing clinical management of kidney disease to drive improved patient outcomes and advance value-based care\n , announces that it has filed a submission seeking clearance of KidneyIntelX™ with the U.S. Food and Drug Administration (FDA). \n This FDA filing\n builds on the Company's regulatory and commercialization program, which includes the June 12, 2020 announcement that the New York State Department of Health has issued a clinical laboratory permit for commercial clinical testing of KidneyIntelX. \n \n \n \n \n \n KidneyIntelX is designed to provide potentially critical new information to health care providers, insurance payors and population health managers in an effort to support optimization of care delivery, improve patient outcomes and reduce the $120 billion annual cost1 of chronic and end-stage kidney disease to the United States healthcare system. \n \n \n \n \n \n In May 2019, RenalytixAI announced that KidneyIntelX was granted Breakthrough Device designation by FDA, the first such designation for an artificial intelligence-enabled in vitro diagnostic for kidney disease publicly announced by any company. FDA clearance is now being sought for the intended use of KidneyIntelX, in conjunction with clinical evaluation, as an aid to further assess the risk of progressive decline in kidney function within a period of up to five years in patients over the age of 21 with type 2 diabetes and existing chronic kidney disease (\"CKD\"). Patients with CKD and type 2 diabetes account for 20-30 percent of the estimated 37 million U.S. patients with CKD2. \n \n \n \n \n \n Performance data provided by RenalytixAI in the FDA 510(k) submission is based on a multi-center validation study of more than 1,100 patients demonstrating that KidneyIntelX accurately identifies patients in early CKD stages 1, 2 and 3 who are...