Research platform
Digital fluorescence reader: prototype and design objectives
A fluorescent lateral flow strip cannot be read by eye. OncoFirm is developing a portable reader to excite the label, measure the emitted light and turn it into a calibrated result. The reader is a prototype. Its performance has not been established.
Design objectives
These are objectives the prototype is being built toward. They are not specifications of a finished device.
Repeatable optics
A fixed optical path, stable light source and sensor chosen so that the same strip gives the same signal on repeat reads.
Calibration that travels
Lot-specific calibration data linked to each cassette, so a result can be traced to the materials that produced it.
Built-in quality checks
Control-line verification, cassette detection and self-test routines that flag invalid runs.
A complete result record
Each result stored with time, device, lot and quality-control data for later audit and analysis.
Standards-based connectivity
Result export designed around established healthcare interoperability standards.
Usable at the point of care
A workflow that a trained non-laboratory user can follow, to be confirmed in human-factors studies.
How the reader fits the platform
The reader is intended to measure strips produced by the fluorescent lateral flow assay format. Raw signal would pass to the signal-interpretation software, designed to apply calibration and report a quantity with quality flags. Reader verification is a stage in the clinical development plan and has to be complete before clinical feasibility data are collected.
Verification plan
- Repeatability and reproducibility across reads, operators, days and devices
- Linearity of the optical response against reference fluorescent standards
- Device-to-device agreement and the effect of temperature and ambient light
- Software verification against a locked requirements specification
- Data integrity, access control and audit trail
Engineering groups with experience in fluorescence detection, embedded systems or medical-device software can lead parts of this work under a defined partner role.
Frequently asked questions
Will the reader work with other manufacturers' strips?
It is being designed for OncoFirm research cassettes. Compatibility with other formats is not a current objective.
Does the reader use AI?
Signal processing and interpretation software is under development. Whether a learned model is used in any final version depends on validation results.
Bring optics, electronics or software expertise
Reader development is a natural work package for an engineering partner on a small business grant.
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.
Device images are concept renderings that illustrate intended functionality.