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KidneyIntelX commercial scale production milestone
KidneyIntelX commercial scale production milestone.
About this update from Renalytix Plc
[{"type":"text","content":"\n \nRNS Number : 0043B Renalytix AI PLC 04 June 2019 \n\nRenalytix AI plc\n(\"RenalytixAI\" or the \"Company\")\n \nCommercial scale manufacturing milestone for KidneyIntelX™ test materials\n \nHigh quality production-scale batches of critical materials successfully produced\nKey milestone achieved for scaled commercial test production\n \nRenalytix AI plc (AIM: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announces that its in-vitro diagnostic manufacturing programme has reached a critical development milestone for the production materials used to measure blood-based biomarkers in the KidneyIntelX™ test. Multiple production-scale lots of the critical materials have been successfully produced and have met the stringent quality control specifications required to scale up manufacturing for commercial production. This milestone results from a successful collaboration with Meso Scale Diagnostics, LLC. (\"MSD\"), based in Rockville, Maryland, the world's leading provider of highly sensitive multiplex immunoassays. \n \nThe KidneyIntelXTM diagnostic test will use machine learning algorithms to assess the combination of predictive blood-based biomarkers, including sTNFR1, sTNFR2 and KIM-1, and features from a patient's electronic health record, to identify those individuals most likely to experience fast-progressing kidney disease. \n \nFergus Fleming, Chief Technology Officer of RenalytixAI, said: \"Working closely with MSD, we have successfully demonstrated that the KidneyIntelX™ biomarkers sTNFR1, sTNFR2 and KIM-1 can be accurately measured using components manufactured in a highly automated, quality-controlled production facility. As a result, we have now secured our supply of biomarker assay components required to support scaled commercial testing.\"\n \nJames Wilbur, Ph.D., General Manager of MSD, noted: \"Our validated V-PLEX immunoassay platform1 was developed specifically for applications like personalised medicine where high-quality data and long-term consistency are essential. The components we are making for the KidneyIntelX™ test use the same processes employed in the V-PLEX product line and will meet comparably stringent requirements.\"\n \nJacob Wohlstadter, President and CEO of MSD, concurred: \"M...