Assays / Cancer antigens
Cancer antigens
CEA (Carcinoembryonic Antigen) — Quantitative Fluorescent Assay
CEA is OncoFirm’s lead assay: a quantitative, fingerstick-to-number test designed to give clinicians a consistent CEA value at the point of care, so changes over time can be followed with confidence.
At a glance
Target
Carcinoembryonic antigen (CEA)
Sample
Serum, plasma or fingerstick whole blood
Readout
Quantitative, ng/mL — designed measuring range 1–100 ng/mL
Calibration
Planned traceability to WHO reference material NIBSC 73/601
Why it matters
Clinical context
CEA is one of the most widely used tumor markers. Its main role is monitoring: after a colorectal cancer diagnosis and treatment, a rising CEA can be an early signal that prompts further imaging or evaluation. Because decisions rest on the trend across many visits, what matters most is a number that is reproducible from one test to the next. CEA is not recommended as a stand-alone screening test for the general population.
How OncoFirm will measure it
Built on the OncoFirm fluorescent platform
Built for serial monitoring
A quantitative value from the same reader and strip design at every visit is intended to make changes in CEA easier to track than a yes/no line.
A strip that checks itself
Every strip carries a fluorescent reference line of known brightness. Reading the test line against it corrects for reader and temperature drift, and the reader flags runs that did not flow correctly.
A traceable digital record
Each result is stored with the date, operator and lot, ready to share with a clinic record or laboratory system instead of being retyped by hand.
Where it's headed
Development roadmap
01
Feasibility
Antibody pairs, fluorescent conjugates and strip layout are selected and tested against the target.
02
Assay development
Strip, reagents and reader settings are optimized, and pilot lots are built.
03
Analytical validation
Precision, linearity, interference and lot-to-lot consistency are measured against reference methods.
04
Clinical evaluation and launch
Performance is evaluated with clinical samples. First release is planned for research use only, followed by regulatory submissions.
Analytical validation will compare results against a laboratory reference method and WHO-traceable calibrators.
Related assays
Development status. This assay and the OncoFirm platform are in development. They have not been cleared or approved by the FDA and are not available for sale. First products are planned for research use only. Descriptions reflect design goals, not demonstrated performance.
Partner on this assay
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