Research platform
Fluorescent lateral flow platform: the research design
OncoFirm is developing a lateral flow immunoassay format that uses fluorescent labels and a calibrated reader, with the aim of measuring cancer-associated protein biomarkers quantitatively. This page describes the design and the open questions. It does not report performance, because that has not been established.
Why fluorescence, and why a reader
Conventional lateral flow tests use colored particles and are read by eye. That works for yes-or-no answers at relatively high analyte concentrations. Fluorescent labels are read by an instrument, so the signal can be measured as a number against a calibration curve. In published work, fluorescent formats have reached lower detection limits than visually read strips in some assay designs, though not in all (a comparison of fluorescent and gold nanoparticle lateral flow assays covers the evidence).
For cancer-associated proteins, where interpretation usually depends on concentration, that is the property worth investigating. If you are new to the format, start with how lateral flow assays work.
The four components under development
Capture and detection antibodies
Antibody pairs selected for affinity and specificity against each target antigen.
Fluorescent reporter chemistry
Labels and conjugation methods evaluated for brightness, stability and low background on the membrane.
Strip and cassette design
Membrane, pads, line placement and flow control, designed for reproducible manufacture.
Reader and software
A portable instrument that excites the label, measures emission and applies lot-specific calibration.
How the format compares with other immunoassay approaches
General characteristics of each format, drawn from the published literature. They are not measurements of an OncoFirm assay.
| Approach | Readout | Typical setting | Trade-offs |
|---|---|---|---|
| Visual lateral flow (colored particles) | Qualitative, by eye | Point of care, home | Simple and low cost; limited sensitivity and no quantification |
| Fluorescent lateral flow with reader | Quantitative or semi-quantitative | Point of care, near-patient laboratory | Needs an instrument; performance depends on label, optics and calibration |
| ELISA | Quantitative | Laboratory | Well established; multi-step and slower |
| Chemiluminescent immunoassay analyzers | Quantitative | Central laboratory | High throughput and sensitivity; needs large instruments and trained staff |
Actual performance of any assay depends on its design and must be shown in analytical validation.
Open research questions
- Which reporter chemistry gives the best signal-to-background on the chosen membrane, and how stable is it in storage?
- How much of the run-to-run variability comes from the strip, the sample matrix and the reader respectively?
- Can more than one analyte be measured on a strip without cross-reactivity or loss of precision?
- What calibration scheme keeps results comparable across manufacturing lots and across instruments?
These are the questions early proposals are built around. Groups with experience in immunoassay development, nanoparticle labels or membrane chemistry can take them on directly through one of the open partner roles.
Frequently asked questions
Is the platform available for evaluation?
Not yet. It is at prototype stage. Technology evaluation with partners will be arranged under agreement as prototypes mature.
Which biomarkers does it detect?
Initial targets are being selected and are discussed with prospective partners under confidentiality.
Does fluorescent detection guarantee better sensitivity?
No. It makes quantitative reading possible and can lower detection limits in some designs, but each assay has to demonstrate its own performance.
Work on the assay with us
We are looking for assay scientists, reagent developers and laboratories with immunoassay validation experience.
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.