Cizzle Biotechnology Holdings (LSE:CIZ) shares skyrocketed, rising 12.4% to 3.5p after its CIZ1B test secured US CLIA approval at OmniHealth Diagnostics.
The CLIA accreditation, delivered with North American licensee Cizzle Bio and OmniHealth, allows licensed US healthcare providers to order the ELISA-based blood test and establishes a regulated laboratory pathway that is necessary for Medicare and Medicaid reimbursement, underpinning commercial launch and revenue potential.
"Validating CIZ1B in a U.S. CLIA-certified laboratory is a pivotal milestone as we move toward broader clinical availability," said Bill Behnke, Founder and CEO of Cizzle Bio.
The CIZ1B assay detects a specific protein variant associated with early-stage lung cancer from a simple blood draw and is offered as a laboratory-developed test performed exclusively in CLIA-certified environments to ensure analytical control and quality oversight.
The company positions the test as a complement to low-dose CT screening, aiming to improve risk stratification, reduce indeterminate findings and limit unnecessary follow-up procedures.
OmniHealth's validation confirms analytical performance and operational readiness for US clinical workflows and provides a foundation to roll the test out across the USA.
