Assays / Cancer antigens
Cancer antigens
PSA (Prostate-Specific Antigen) — Quantitative Fluorescent Assay
PSA is OncoFirm’s second cancer program, designed to run on the same handheld reader and strip format as CEA and return a quantitative total PSA value in minutes.
At a glance
Target
Total prostate-specific antigen (PSA)
Sample
Serum, plasma or fingerstick whole blood
Readout
Quantitative, ng/mL — designed measuring range 0.5–50 ng/mL
Calibration
Planned traceability to WHO reference material NIBSC 17/100
Why it matters
Clinical context
PSA testing supports shared decisions about prostate cancer screening and is used to monitor men after diagnosis or treatment. A single value rarely tells the whole story; clinicians look at the level, how it changes over time and the patient’s risk factors. That makes a consistent, quantitative result more useful than a qualitative cut-off.
How OncoFirm will measure it
Built on the OncoFirm fluorescent platform
One reader, two cancer markers
PSA is designed to share the reader, strip architecture and software with CEA, so adding it does not require new equipment.
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.
Development follows the CEA program and reuses its reference-line calibration approach.
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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