Research platform
Antigen-based cancer biomarker research
Cancer-associated antigens are proteins that tumors produce or over-express and that can be measured with antibodies. This page sets out how OncoFirm selects targets and antibody pairs for research assays, and what the approach can and cannot tell a clinician.
What antigen measurement can and cannot do
Serum protein markers such as PSA, CEA, CA-125, CA 19-9, AFP and HE4 have been used in oncology for decades, mostly for monitoring and, in selected settings, as an aid in diagnosis. They are examples of the class. They are not a list of OncoFirm assays.
Their limits are well documented. Levels rise in benign conditions, some tumors do not express them, and no single marker is specific enough to stand alone (Duffy, 2013). Antigen results are interpreted with imaging, pathology and clinical findings. Any new assay has to be designed with that in mind. Our guide to tumor antigen detection goes through the antigen classes and assay formats in more depth.
How targets and reagents will be chosen
Clinical question first
A target is considered only when a measured value would inform a real decision for a defined population.
Published evidence
Preference goes to antigens with a peer-reviewed record in the relevant cancer and specimen type.
Antibody pair quality
Capture and detection antibodies will be screened for affinity, specificity and performance on the membrane, not only in solution.
Fit with the format
The expected concentration range has to sit within what a lateral flow format can measure.
Panel logic
Where single markers lack specificity, combinations are studied, with the statistical cost of multiple markers accounted for.
Supply and reproducibility
Reagents must be available at consistent quality, with documentation that supports later regulatory work.
From antigen to assay
In the planned workflow, selected antibody pairs go into the fluorescent lateral flow format, where the detection antibody carries a fluorescent label and the capture antibody is fixed on the test line. The digital reader is intended to measure the signal and convert it to a concentration using lot-specific calibration.
Background on the biology is in what cancer biomarkers are and how they are validated. A wider reference, the OncoFirm Cancer Biomarker Atlas, is in preparation and open to contributors.
Where partners come in
Biomarker and antibody research is the first of our R&D priorities and the one where outside expertise changes the outcome most. We are looking for:
- Investigators with data on candidate protein biomarkers in a specific cancer
- Groups holding validated antibody pairs or recombinant antigens they wish to see developed
- Technology-transfer offices with biomarker or antibody IP available for licensing or joint development
- Biobanks able to support early feasibility testing on characterized specimens
How IP is handled in collaborations explains the terms we work to.
Frequently asked questions
Are antigen tests diagnostic on their own?
No. Protein marker results are used alongside imaging, pathology and clinical assessment.
Can we propose a biomarker we have discovered?
Yes. Send a non-confidential outline and we will arrange a confidentiality agreement before discussing detail.
References and further reading
- Duffy MJ. Tumor markers in clinical practice: a review focusing on common solid cancers. Med Princ Pract. 2013;22(1):4–11.
- Hanahan D. Hallmarks of cancer: new dimensions. Cancer Discov. 2022;12(1):31–46.
Have a biomarker or antibody worth developing?
We can help take it into an assay format and build the grant proposal around it.
Research and regulatory status
OncoFirm™ technologies described on this site are in research and development. Their performance characteristics have not been established, and no OncoFirm product has been cleared, approved or authorized by the U.S. Food and Drug Administration. Nothing here is medical advice. Reference to a federal agency or funding program does not imply endorsement, funding, sponsorship or affiliation.