US laboratory approval supports launch of lung cancer blood test
pharmafile | June 17, 2026 | News story | | lung cancer blood test
UK based Cizzle Biotechnology has announced that its CIZ1B lung cancer blood test has been approved for use under Clinical Laboratory Improvement Amendments (CLIA) accreditation at OmniHealth Diagnostics in Texas, opening a route to clinical use in the US.
The test is designed to support earlier detection of lung cancer through analysis of a blood sample and represents the first commercial deployment of the company’s technology.
Lung cancer remains the leading cause of cancer-related deaths in the US, with more than 234,000 new cases diagnosed annually. Although more than 14 million Americans are eligible for annual lung cancer screening, uptake remains relatively low.
The CIZ1B test uses a protein biomarker associated with early-stage lung cancer and is intended to complement existing screening pathways, including low-dose computed tomography (CT) scans.
Professor Dawn Coverley, Founder and Chief Scientific Officer of Cizzle Biotechnology (pictured), said the test’s low cost and minimal blood requirements could support wider adoption in screening programmes.
“After years of work by dedicated scientists here in York, seeing the CIZ1B test finally move from bench to clinic is wonderful,” she commented.
The approval follows validation work conducted with OmniHealth Diagnostics, a CLIA-certified and COLA-accredited clinical laboratory.
According to the company, earlier diagnosis remains a key challenge in lung cancer care because symptoms are often not recognised until disease has reached a more advanced stage. Survival outcomes are significantly improved when the disease is detected earlier.
Allan Syms, Executive Chairman of Cizzle Biotechnology, said the accreditation process demonstrated the test’s reliability and accuracy for clinical use.
The company said it will now pursue additional commercial partnerships in the UK, Europe and Asia as part of its broader licensing strategy.
