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Update on Launch of CIZ1B Biomarker Assay
Update on Launch of CIZ1B Biomarker Assay.
About this update from Cizzle Biotechnology Holdings Plc
[{"type":"text","content":"\n\nTHIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF EU REGULATION 596/2014 (WHICH FORMS PART OF DOMESTIC UK LAW PURSUANT TO THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (\"EUWA\")) (\"UK MAR\")\n24 March 2025\nCizzle Biotechnology Holdings plc\n \n(\"Cizzle\", \"Cizzle Biotechnology\", or the \"Company\")\n \nFirst COLA and CLIA Accredited Laboratory in USA confirmed\nUpdate on Launch of CIZ1B Biomarker Assay\nCizzle Biotechnology, the UK based diagnostics developer of early cancer tests, is pleased to announce that its licensing partner Cizzle Bio Inc (\"BIO\" or \"Cizzle Bio\") has appointed iGenomeDX, a specialist clinical diagnostics laboratory to launch the Company's first commercial CIZ1B biomarker test in the USA. iGenomeDX is a Commission on Office Laboratory Accreditation (\"COLA\") accredited and Clinical Laboratory Improvement Amendments (\"CLIA\") certified clinical laboratory and has been establishing operating and quality systems ahead of offering the test to clinicians for the first time.\n \nKey Highlights\n \n· iGenoneDX appointed by BIO as first clinical diagnostics laboratory to offer commercial CIZ1B biomarker testing.\n \n· This follows successful collaboration and support between Cizzle, iGenomeDX and BIO to complete an operational and quality systems programme designed to meet the exacting standards required in iGenomeDX's COLA accredited, CLIA certified laboratory, designated to validate CIZ1b as a laboratory developed test for commercial use ahead of the launch of the CIZ1B biomarker test.\n \nBackground\n \nOn 21 October 2024 the Company announced an exclusive licensing and partnership agreement with BIO for its proprietary CIZ1B biomarker test to help detect early-stage lung cancer, throughout the USA and Canada. The Company has since received payments of US$400,000 due from initial exclusivity fees and advanced royalties as part of guaranteed payments totalling US$2.4 million over the period ending April 2027. The Company has now extended that agreement, as announced on 16 December 2024, to cover the 14 Sovereign States of the Caribbean and the Cayman Islands (\"Caribbean\") triggering early payments totalling US$250,000 in July 2025 and US$250,000 in September 2025.\n \nThe appoint...