Cizzle Bio
Cizzle Bio is a Texas-based biotechnology company developing minimally invasive blood tests for early cancer detection, including the CIZ1B biomarker test for lung cancer and the DEX-G2 test for gastric cancer, serving high-risk patients and U.S. healthcare providers.
- Company typePrivate
- Founded2024
- HeadquartersSan Antonio, United States
- Headcount1–10
- GTM typeB2B
- OfferingServices
What Cizzle Bio does
Cizzle Bio, Inc. is a San Antonio, Texas-based biotechnology company developing minimally invasive biomarker blood tests for early detection of lung and gastric cancers, two of the world's deadliest malignancies. The company's portfolio comprises two flagship Laboratory Developed Tests (LDTs): the CIZ1B ELISA-based immunoassay for lung cancer (95% sensitivity for Stage I detection and 96% negative predictive value in prior studies) and the DEX-G2 PCR-based molecular assay for gastric cancer (95% sensitivity, 97% specificity, 0.96 AUC), which leverages a proprietary dual-action mechanism combining cell-free and exosomal miRNAs. Both tests are designed for use in CLIA-certified, CAP-accredited laboratory environments and target high-risk patient populations—including those unable or unwilling to undergo low-dose CT screening, patients with indeterminate pulmonary nodules, individuals with occupational exposures, and patients with chronic lung or GI conditions. The underlying technology was developed through more than 30 years of CIZ1 gene research at the University of York and DEX-G2 research at City of Hope Comprehensive Cancer Center (led by Dr. Ajay Goel).
The company operates as the exclusive North American licensing partner of UK-listed Cizzle Biotechnology Holdings plc (LSE:CZZ), which owns the underlying IP. Under this licensing arrangement, Cizzle Bio commercializes the tests in the U.S., Canada, and the Caribbean while paying a 10% royalty on gross sales back to the parent. Tests are ordered by licensed U.S. healthcare providers via a secure online portal and processed by CLIA-certified partner laboratories, with OmniHealth Diagnostics (Dallas, TX) serving as the validated launch partner following CLIA lab validation completion in June 2026. Initial commercial pricing is private pay with a CPT code application planned to follow. The company holds granted patents in the United States (USPTO, June 2026), Canada (February 2026), and from the European Patent Office, and is pursuing additional licensing partnerships with NHS facilities in the UK and Europe.
Cizzle Bio is in pre-commercial launch phase as of mid-2026, with revenue not yet generated. Capital is sourced primarily from guaranteed minimum royalty commitments (US$2.4M in advance royalties due by end of 2026 plus an additional US$3.5M commencing in 2031, totaling at least US$5.9M from the parent) and a small US$14,650 raise in September 2025. The company has 1–10 employees, ongoing clinical validation studies at NCI-designated cancer centers (Moffitt and Mays Cancer Center/UT Health San Antonio), and is pursuing additional laboratory partnerships as part of U.S. launch readiness. Leadership includes CEO Bill Behnke, who has moderated panels at major industry venues including the 2025 AVBCC Summit and the 25th Cancer Center Informatics Society Summit (Ci4CC) in May 2026.
Cizzle Bio firmographics
Firmographics- Name
- Cizzle Bio
- Legal name
- Cizzle Bio, Inc.
- Website
- https://cizzlebio.com
- Company type
- Private
- Founded year
- 2024
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Cizzle Bio is a Texas-based biotechnology company developing minimally invasive blood tests for early cancer detection, including the CIZ1B biomarker test for lung cancer and the DEX-G2 test for gastric cancer, serving high-risk patients and U.S. healthcare providers.
- Ownership category
- akta.pro rank
Cizzle Bio industry classification
Industry- Product category
- Cancer Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)
- akta.pro secondary industries
- Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Liquid Biopsy Biomarkers (ctDNA/ctRNA/CTCs/exosomes) (HLAAAMAH)
Keywords
Where Cizzle Bio is headquartered
LocationHeadquarters
- HQ city
- San Antonio
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
Cizzle Bio business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales
Revenue model
- Biomarker Blood Test Sales: Revenue from commercializing CIZ1B and DEX-G2 biomarker blood tests to licensed U.S. healthcare providers. Cizzle Bio receives 10% royalty on gross sales of its CIZ1B biomarker test under licensing agreement with Cizzle Biotechnology Holdings plc.
- Laboratory Testing Services: Tests processed by CLIA-certified, CAP-accredited partner laboratories with results delivered via secure online portal. Initially private pay with CPT application to follow.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Laboratory Developed Test (LDT) for healthcare providers |
Go-to-market motion2 records
Distribution channels2 records
Marketing channels5 records
Cizzle Bio product offering
Product offeringCore offering
Cizzle Bio develops and licenses proprietary biomarker blood tests for early-stage cancer detection, with two flagship products: CIZ1B (an ELISA-based immunoassay for lung cancer) and DEX-G2 (a PCR-based molecular assay for gastric cancer). The tests are designed as Laboratory Developed Tests (LDTs) ordered by licensed U.S. healthcare providers through a secure online portal and processed by CLIA-certified partner laboratories. The company also holds North American and Caribbean commercialization rights to the underlying patented biomarker technology developed at the University of York and in collaboration with City of Hope.
Product overview
Cizzle Bio is a Texas-based biotechnology company developing minimally invasive biomarker blood tests for early cancer detection. The company offers two flagship products: CIZ1B for lung cancer detection (ELISA-based immunoassay with 95% sensitivity for Stage I) and DEX-G2 for gastric cancer detection (PCR-based test using cell-free and exosomal miRNAs with 95% sensitivity and 97% specificity). Both tests are designed as Laboratory Developed Tests (LDTs) for use within the U.S. clinical laboratory environment.
Differentiator
Problem solved
Functional benefit
Brands
- CIZ1B: Biomarker blood test for early detection of lung cancer with 95% sensitivity for Stage I detection and 96% negative predictive value
- DEX-G2
Products and services
- CIZ1B CIZ1B is a proprietary ELISA-based immunoassay blood test for early-stage lung cancer detection that measures the CIZ1 (CIZ1B) biomarker and demonstrates 95% sensitivity for Stage I lung cancer detection and 96% negative predictive value. It is designed to be ordered by licensed U.S. healthcare providers through a secure online portal and processed by CLIA-certified partner laboratories as a Laboratory Developed Test (LDT).
- DEX-G2 DEX-G2 is a proprietary PCR-based molecular assay blood test for early gastric cancer detection using a dual-action biomarker combination of cell-free and exosomal miRNAs, achieving 95% sensitivity and 97% specificity with a 0.96 AUC. It is designed as a Laboratory Developed Test (LDT) ordered by licensed U.S. healthcare providers — particularly gastroenterologists — and processed by CLIA-certified partner laboratories, with patented methodology granted in the United States, Canada, and Europe.
Quantifiable outcome
- Integrating CIZ1B biomarker blood test into Medicare lung cancer screening could save $518 million annually
- +4 more outcomes
Companies that use Cizzle Bio
Customer profileNamed customers2 records
Segments3 records
Ideal customer profiles2 records
Cizzle Bio technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Cizzle Bio partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered core, major and strategic.
- OmniHealth DiagnosticscoreOmniHealth Diagnostics is a CLIA-certified clinical laboratory in Dallas that completed laboratory validation for Cizzle Bio's CIZ1B biomarker blood test. The validation confirms the test's readiness for use within a U.S. clinical laboratory environment. Cizzle Bio is expanding validation efforts with this laboratory partner and finalizing launch readiness activities for near-term availability.
- City of Hope Comprehensive Cancer CentercoreCity of Hope is a key collaborator in the development of the DEX-G2 gastric cancer detection test. Dr. Ajay Goel, Professor and Chair of Molecular Diagnostics and Experimental Therapeutics at City of Hope, led the research that combined cell-free and exosomal miRNAs to create the test. Cizzle Bio holds exclusive licensing rights for the DEX-G2 test in the U.S.
- Cizzle Biotechnology Holdings plccoreCizzle Biotechnology Holdings plc is the parent UK-based company that licensed the CIZ1B biomarker technology to Cizzle Bio Inc for North America and the Caribbean. Under the license agreement, Cizzle Biotechnology receives 10% royalty on gross sales and has secured additional guaranteed minimum royalty payments totaling at least US$5.9 million over the contract term.
- Moffitt Cancer CentermajorMoffitt Cancer Center is conducting ongoing clinical validation studies for the CIZ1B biomarker test as an NCI-designated cancer center. Preliminary U.S. clinical validation data is forthcoming from these studies.
- BBI SolutionsstrategicBBI Solutions is listed as a partner collaborating with Cizzle Bio in developing minimally invasive biomarker blood tests. The partnership is part of integrating these tests into mainstream healthcare.
- University of YorkcoreThe CIZ1B two-step test format was developed at the University of York through more than 30 years of research into the CIZ1 gene and its role in cell cycle regulation. The technology is licensed to Cizzle Bio Inc for North America and the Caribbean.
- Mays Cancer Center/UT Health San Antonio MD Anderson Cancer CentermajorMays Cancer Center is conducting ongoing clinical validation studies for the CIZ1B biomarker test as an NCI-designated cancer center. Preliminary U.S. clinical validation data is forthcoming from these studies.
Scale indicators8 records
Recent moves6 records
Expansion highlights6 records
Cizzle Bio competitors and assessment
Company assessmentDirect peers
- GRAIL: GRAIL's Galleri is a multi-cancer early-detection blood test positioned for asymptomatic screening, the same clinical use case as Cizzle Bio's CIZ1B. Both compete for the same health-system and employer-sponsored screening dollar, making GRAIL the most direct strategic comparator.
- Oncimmune Holdings: Oncimmune's EarlyCDT Lung is a blood-based immunoassay for early-stage lung cancer detection, making it the closest single-cancer, single-modality direct competitor to Cizzle Bio's CIZ1B in the lung cancer screening conversation.
- Biodesix: Biodesix offers blood-based lung cancer diagnostics (e.g., Nodify XL2 for pulmonary nodules), sharing the pulmonology/oncology channel and indeterminate-nodule use case that Cizzle Bio's CIZ1B explicitly targets.
- Guardant Health: Guardant offers blood-based liquid biopsy diagnostics across oncology, including the Shield colorectal screening test and Reveal MRD assay, directly overlapping Cizzle Bio's biomarker-blood-test proposition for early cancer detection in high-risk patients.
Others
- Bio-Techne: Bio-Techne supplies reagents and biomarker assay components (including those used in ELISA and exosome/miRNA workflows) that sit upstream of Cizzle Bio's clinical tests, making it an adjacent technology and supply-chain comparable.
Broad incumbents
- Veracyte: Veracyte's Afirma (thyroid) and pulmonary-nodule offerings compete in physician-ordered molecular diagnostics, with an established urology/pulmonology sales force that overlaps the buyer profile Cizzle Bio is building toward.
- Natera: Natera's Signatera MRD test and growing oncology franchise compete in the same physician-ordered blood-based oncology testing market and share distribution overlap with Cizzle Bio's planned pulmonologist/oncologist channel.
- Exact Sciences: Exact Sciences (Cologuard, Oncotype DX, Thrive) is the established leader in blood- and stool-based cancer screening with deep payer coverage and primary-care GTM, representing the competitive benchmark Cizzle Bio must meet to win Medicare/private payer inclusion.
Regional players
- NeoGenomics: NeoGenomics runs a US-based oncology-focused clinical laboratory network with broad oncologist relationships and could be either a partner lab or a channel competitor as Cizzle Bio builds its CLIA-network and physician-channel.
Emerging players
- Freenome: Freenome is developing multiomics blood-based cancer screening (colorectal lead program) with the same minimally invasive, biomarker-driven early-detection thesis that underpins Cizzle Bio's pipeline expansion roadmap.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks7 records
Key highlights7 records
Customer concentration
Cizzle Bio social profiles
Digital presenceCizzle Bio compliance and trust
Trust signalCompliance1 record
Cizzle Bio financial estimates
Financial estimateRevenue estimate
Valuation estimate
Cizzle Bio leadership team
Management profileNumber of profiles
Profiles1 record
Cizzle Bio subsidiaries and ownership
Company hierarchySubsidiaries1 record
Cizzle Bio funding detail
Funding detailFunding overview
Funding rounds1 record
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Cizzle Bio M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Cizzle Bio
What does Cizzle Bio do?
Cizzle Bio develops and licenses proprietary biomarker blood tests for early-stage cancer detection, with two flagship products: CIZ1B (an ELISA-based immunoassay for lung cancer) and DEX-G2 (a PCR-based molecular assay for gastric cancer). The tests are designed as Laboratory Developed Tests (LDTs) ordered by licensed U.S. healthcare providers through a secure online portal and processed by CLIA-certified partner laboratories. The company also holds North American and Caribbean commercialization rights to the underlying patented biomarker technology developed at the University of York and in collaboration with City of Hope.
Is Cizzle Bio a public or private company?
Cizzle Bio is a private company. It is classified as corporate owned and is currently operating.
When was Cizzle Bio founded?
Cizzle Bio was founded in 2024. It employs 1 to 10 people.
Where is Cizzle Bio based?
Cizzle Bio is headquartered in San Antonio, United States, in the North America region.
How does Cizzle Bio make money?
Two revenue lines are on record. Biomarker Blood Test Sales are the primary driver. The others are laboratory Testing Services.
Who are Cizzle Bio's main competitors?
Direct peers on record are GRAIL, Oncimmune Holdings, Biodesix and Guardant Health. Bio-Techne is listed as an others. Broad incumbents are Veracyte, Natera and Exact Sciences. NeoGenomics is listed as a regional player. Freenome is listed as an emerging player.
Does Cizzle Bio have an API?
No public API is recorded for Cizzle Bio.
What industry is Cizzle Bio in?
Cizzle Bio's product category is Cancer Diagnostics. Its primary akta.pro industry code is HLAAAMAC, Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays), with a secondary code of HLAAALAE, Oncology Diagnostics (tumor profiling, MRD, liquid biopsy). Its NAICS code is 325413 and its SIC code is 2835.