iGenomeDX Appointed as First COLA and CLIA Accredited Laboratory to Launch CIZ1B Lung Cancer Test
We are excited to share a major milestone in our mission to advance early lung cancer detection. Our licensing partner, Cizzle Biotechnology Holdings plc (UK), has officially announced Cizzle Bio’s appointment of iGenomeDX, a COLA-accredited and CLIA-certified clinical diagnostics laboratory, to launch the first commercial CIZ1B biomarker test in the United States.
Why This Matters
This appointment confirms that iGenomeDX has successfully completed the required operational and quality systems program to meet the highest standards of clinical diagnostics. These certifications ensure that the CIZ1B test will be conducted in a laboratory setting that prioritizes accuracy, patient safety, and regulatory compliance.
Key Highlights
iGenomeDX, based in San Antonio, Texas, is now the first lab in the United States accredited to offer the CIZ1B biomarker test.
The lab holds COLA accreditation and is CLIA-certified, meeting stringent U.S. federal standards for diagnostic testing.
The test will be introduced as a laboratory developed test (LDT) for early-stage lung cancer detection.
This step follows successful collaboration between Cizzle Biotechnology, Cizzle Bio, Inc., and iGenomeDX to establish a scalable, quality-controlled testing platform.
Background on Our Progress
Since entering into an exclusive licensing agreement with Cizzle Biotechnology (UK) in October 2024, Cizzle Bio has made rapid progress toward bringing this life-saving test to market:
Secured $400,000 in exclusivity fees and advanced royalties (with $2.4 million guaranteed through 2027).
Expanded licensing to include the Caribbean and Cayman Islands, with additional early payments totaling $500,000 expected in 2025.
Initiated collaborations with multiple NCI-designated cancer centers across the U.S.
Strengthened our leadership team with experienced clinical and industry professionals.
What’s Next
With iGenomeDX now having completed rigorous operational and quality systems programs, we are on track to make the CIZ1B blood test available to clinicians later this year. The test is a non-invasive, cost-effective solution designed to help detect lung cancer at its earliest and most treatable stages.
Stay tuned for further updates as we move toward the official commercial launch of the CIZ1B test.
To read the full announcement from Cizzle Biotechnology (UK), click here.
About Cizzle Bio, Inc.
Cizzle Bio is a Texas-based biotechnology company with exclusive rights to commercialize the CIZ1B biomarker test in the United States and Canada. Our goal is to revolutionize cancer diagnostics and empower clinicians with earlier, more accurate detection tools.
Learn more: https://cizzlebio.com
About Cizzle Biotechnology
Cizzle Biotechnology is a UK-based diagnostics developer focused on the early detection of lung cancer. The company’s proprietary CIZ1B biomarker, based on the work of Professor Coverley and colleagues, is highly associated with early-stage cancer. Cizzle Biotechnology has developed a non-invasive, cost-effective blood test for early lung cancer detection and has entered into exclusive licensing agreements and collaborations with centers of excellence in cancer care.
Learn more: https://cizzlebiotechnology.com
About iGenomeDX
iGenomeDX is a CLIA-certified, COLA-accredited clinical lab specializing in pharmacogenomics and molecular diagnostics. Based in San Antonio, TX, they provide high-quality testing services designed to support personalized medicine.
Explore their services: https://igenomedx.com
