Business
CLIA Certificate of Compliance update
CLIA Certificate of Compliance update.
About this update from Verici Dx Plc
[{"type":"text","content":"\n\n\nVerici Dx plc\n(\"Verici Dx\" or the \"Company\")\n \nCLIA Certificate of Compliance update\n \nUS clinical laboratory now fully accredited in 49 states\n \nVerici Dx plc (AIM: VRCI), a developer of advanced clinical diagnostics for organ transplant, announces that further to the RNS dated 2 March 2023, the Company has received compliance authorisation for the operation of its commercial clinical laboratory testing in respect of samples from an additional four US states, including the important addition of California, with the Company laboratory now fully accredited in a total of 49 states. \n \nTogether with the CLIA certification previously obtained from the Centers for Medicare & Medicaid (\"CMS\"), clinicians at transplant medical centres in these additional states are now enabled to order Verici Dx's transplant tests, expanding the Company's commercial reach. California has consistently accounted for over 10 per cent. of the national US volume of kidney transplant procedures in each year since 1998 and has conducted the highest volume of transplants by any state each year over the same period.\n \nVerici Dx launched its first product, Tutivia™, for the detection of acute rejection in kidney post-transplant patients, in January 2023 and recently announced the successful validation of Clarava™, a first-in-class pre-transplant prognosis test for the risk of early acute rejection in deceased donor recipients, which it expects to launch later this year. The additional state accreditations provide further validation of Verici Dx's clinical laboratory for its tests to be used by transplant clinicians across the US.\n \nThe Company continues to work towards full accreditation in the final state of New York, which has its own compliance requirements. \n \nThe CLIA certification and additional state approvals further exemplify Verici's commitment to a quality-focused approach to providing advanced kidney transplant diagnostic services to clinicians and patients in need. \n \nSara Barrington, CEO of Verici Dx, said: \"This is another important step in our strategy, expanding our commercial reach and making it easier for clinicians to order our tests helping to drive the adoption of both Tutivia™ and Clarava™ .\"\n \n \nEnquiries:\n \n\n\n\n\nVerici ...