Business
New commercial testing facility opens in Utah
New commercial testing facility opens in Utah.
About this update from Renalytix Plc
[{"type":"text","content":"\n \nRNS Number : 1130Z Renalytix AI PLC 08 January 2020 \n\nThis announcement contains inside information\n \nRenalytix AI plc\n(\"RenalytixAI\", the \"Company\" or the \"Group\")\n \nNew commercial testing facility opens in Utah\n \nUtah issues CLIA Certificate of Registration to allow patient testing\n \nNew laboratory enables five-fold test volume increase to support 2020 commercial goals\n \nRenalytix AI plc (LSE: RENX), a developer of artificial intelligence enabled clinical diagnostics for kidney disease, announces that it has received a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Registration for its newly established clinical laboratory operation in Salt Lake City, Utah. \n \nThe Salt Lake City laboratory facility supports the delivery of multiple elements in the Company's 2020 commercial strategy plan, including the scaling-up of test volumes, optimizing sample processing costs and accelerating payor coverage determinations. With the receipt of the Certificate of Registration, the Utah laboratory is now authorised to begin patient testing effective immediately.\n \nEffects of the Salt Lake City commercial laboratory \n \nA primary benefit of the new Salt Lake City commercial laboratory, in combination with the Company's New York City facility, is to enable a five-fold increase in maximum potential processing capacity to approximately 15,000 reportable test results per month across both sites while also providing significant risk mitigation through operational redundancy. The Salt Lake Facility is expected to begin operating in calendar Q2 of this year. \n \nIn addition, the issuance of the Utah laboratory CLIA Certificate of Registration allows RenalytixAI to initiate its request for a Local Coverage Determination (LCD) from Noridian Healthcare Solutions, the regional Medicare Administrative Contractor (MAC) responsible for services performed in laboratories located in the State of Utah. Once granted, the LCD applies to payment for KidneyIntelX™ tests run in the Utah laboratory on patient samples received from all 50 US states. The LCD is expected to take approximately 12 months and would be in addition to both coverage determination policies already adopted by insurance payor CDPHP as announced on 17 October 2019 (RNS: 1517Q), and furt...