● Biotechnology · Early cancer diagnostics
OncoFirm™ Proprietary Fluorescent Lateral Flow Technology
OncoFirm™ Diagnostics is developing a self-calibrating fluorescent lateral flow platform intended to redefine how biomarkers are detected at the point of care: a test strip that carries a fluorescent reference line of known brightness, and a handheld reader that images the whole strip.
Development stage · First products planned for research use only · Not cleared or approved by the FDA · Not available for sale
Sample padFluorescent conjugateMembrane · capture zonesAbsorbent pad
● The OncoFirm™ platform advantage
Transforming biomarker testing through innovation
A platform designed for the future of oncology diagnostics — built to bring laboratory-grade signal measurement to a rapid, portable test format.
01
Proprietary fluorescent detection
Advanced fluorescence-based signal amplification intended to enhance biomarker detection beyond conventional colorimetric rapid tests.
02
Rapid point-of-care testing
Simple workflows designed to deliver actionable results within minutes rather than days.
03
Multiplex biomarker capability
Platform architecture intended to support multiple cancer biomarkers and future multi-analyte testing applications.
04
Digital integration
Designed for the OncoFirm™ Electronic Reader, enabling objective fluorescence measurement, digital interpretation and data management.
● Self-calibrating by design
A reference line of known brightness on every strip
Each OncoFirm™ strip carries three lines: a test line, a quantitative fluorescent reference line and a control line. Reading the test line against the reference line on the same strip is what makes the result self-calibrating.
Test ÷ reference ratio
The ratio of the test line to the reference line corrects each result for reader-light and temperature drift.
Timed reads, flagged runs
The reader records the full fluorescence profile at several time points. Flow and release problems are flagged from the shape of the signal and from the timed reads.
Lot calibration
A lot calibration curve handles differences between reagent lots.
Traceable to WHO standards
Calibration is planned to trace to WHO reference materials for CEA (NIBSC 73/601) and PSA (NIBSC 17/100).
Lead test program
In development
CEA
Carcinoembryonic antigen
Designed measuring range
1 – 100 ng/mL
Second test program
In development
PSA
Prostate-specific antigen · same reader
Designed measuring range
0.5 – 50 ng/mL
Measuring ranges are design targets for products in development, not validated performance claims.
● How it works
From sample to standardized, digital result
Samples migrate across a membrane by capillary action. Target biomarkers bind to detection antigen or antibodies labeled with fluorescent particles, and the immune complexes are captured by immobilized antibodies at designated reaction zones. The handheld reader then excites the fluorescent labels and measures the emitted light.
1
Sample collection
Whole blood, serum or plasma is applied to the sample pad.
2
Antigen recognition
Cancer-associated antigens bind highly specific, fluorescently labeled antibodies.
3
Signal generation
Immune complexes are captured at the test line; the reference and control lines develop alongside.
4
Fluorescence detection
The handheld reader images the whole strip, recording the full fluorescence profile at several time points.
5
Digital analysis
The test-to-reference ratio and lot calibration curve produce a standardized result; abnormal runs are flagged.
Instead of traditional gold nanoparticles, the platform uses fluorescent reporter technologies that enable optical signal measurement.
Moving from a visual color change to a measured optical signal is what allows results to be read objectively, quantified, stored and analyzed — the foundation for multiplexing, digital records and AI-assisted interpretation.
● Fluorescent vs. colorimetric
Why fluorescence changes what a rapid test can do
| Attribute | OncoFirm™ fluorescent | Conventional colorimetric |
|---|---|---|
| Result reading | Objective digital measurement | Visual interpretation of a colored line |
| Output | Quantitative or semi-quantitative | Typically qualitative (yes / no) |
| Observer variability | Reduced by instrument reading | Dependent on the reader's eye and lighting |
| Multiplexing | Designed for multiple biomarkers | Limited |
| Data & analysis | Structured data for computational and AI analysis | Manual recording |
| Workflow | Improved standardization | Varies by operator |
Describes design objectives of a platform in development; not claims of clinical performance.
● Core components
Four technologies, engineered as one system
Each layer — from antigen and antibody to software — is developed to support reliable biomarker recognition and consistent, reportable results.
Antibody - Antigen technology
Highly specific antibody–antigen interactions, with antibody selection and assay optimization to support reliable biomarker recognition while minimizing nonspecific binding.
Fluorescent reporter chemistry
Fluorescent reporters in place of gold nanoparticles, enabling measured optical signals rather than visual color change.
Precision optical reader
A dedicated reader for fluorescence excitation and emission measurement.
Intelligent software
Software architecture that turns raw optical signal into standardized, reportable data.
● Digital diagnostics
The OncoFirm™ Electronic Reader and AI-assisted interpretation
Digital fluorescence measurements create structured datasets that can support advanced computational analysis — from automated signal interpretation to decision-support tools.
A handheld reader that images the whole strip
The OncoFirm™ reader records the full fluorescence profile of the strip at several time points and flags tests that ran abnormally. One reader is designed to run both the CEA and PSA tests.
- Automated signal interpretation
- Background correction
- Workflow optimization
- Cloud-enabled data management
- Image quality assessment
- Trend analysis
- Decision-support tools
- LIS integration
● A broad technology platform
Designed for multiple healthcare settings
Innovation that starts with earlier detection: the platform is being developed across a range of oncology applications and care environments, designed to complement established laboratory diagnostics.
Development focus areas
- Early cancer screening
- Cancer-associated protein biomarkers
- Tumor-associated antigen detection
- Antibody biomarker assays
- Disease monitoring
- Companion diagnostics
- Precision medicine applications
- Clinical research tools
Intended healthcare settings
- Hospitals
- Physician offices & oncology practices
- Independent laboratories
- Community health clinics
- Urgent care centers
- Mobile healthcare programs
- Resource-limited & international markets
- Research institutions
● Positioned within high-growth diagnostic markets
At the intersection of several expanding healthcare sectors
In vitro diagnostics (IVD)Point-of-care diagnosticsCancer biomarker testingPrecision oncologyMolecular & protein biomarkersDigital diagnosticsAI-assisted diagnostic interpretationPersonalized medicine
Intellectual property driven
A proprietary platform spanning fluorescent reporter chemistry, assay design, reader hardware and interpretation software.
Platform, not a single test
One architecture intended to extend across multiple cancer biomarkers and future multi-analyte panels.
Built for scale
Portable workflows designed for decentralized care, from physician offices to mobile and international programs.
● For strategic partners and investors
Help bring earlier cancer detection to the point of care
OncoFirm™ Diagnostics actively seeks collaboration to advance development, validation and commercialization of the platform.
Healthcare organizationsCancer research institutionsDiagnostic laboratoriesBiotechnology companiesDistribution partnersClinical collaboratorsStrategic investorsCommercialization partners
● About OncoFirm™ Diagnostics
Antigen-based diagnostics for the early detection of cancer
OncoFirm™ Diagnostics Corporation is a New York corporation established in 2025, developing a self-calibrating fluorescent lateral flow platform for quantitative cancer biomarker testing.
Mission
Transform cancer detection through innovative biomarker discovery and next-generation in vitro diagnostic (IVD) technologies that enable earlier, faster, and more accurate diagnosis.
Vision
A future where highly sensitive biomarker-based diagnostics become the standard of care for cancer screening and disease monitoring.
Scientific excellence
Innovation in IVD
Accessibility
Collaboration
Jonathan Adam BarashChief Executive Officer · Program Director / Principal Investigator
| Established | 2025 · New York |
|---|---|
| SAM.gov UEI | KZTAC1G5SAN8 |
| CAGE code | 23AM5 |
| NAICS | 325413 |
FDA establishment registration is not clearance or approval of any product.
Contact
- Company
- OncoFirm™ Diagnostics Corporation
- Corporate office
- 24 Dolphin Grn., #H2C
Port Washington, NY 11050 - Laboratory
- Broad Hollow Bioscience Park
3 Bioscience Park Dr., Farmingdale State College
Farmingdale, NY 11735-1021 - Phone
- +1 516.900.2606
- Fax
- +1 516.900.3350
- info@oncofirm.com
- Website
- oncofirm.com
Regulatory notice
These are product concepts not available for sale. These products are not available in the USA. All products are in development; none has been cleared or approved by the FDA. First products are planned for research use only (RUO).
Products described reflect development objectives and should not be interpreted as claims of current clinical performance or regulatory clearance. Products are not intended for diagnostic use unless and until authorized or approved by the appropriate regulatory authorities. The platform is designed to complement established laboratory diagnostics.
Concept renderings. OncoFirm™ device and results shown are illustrative of intended functionality; the product is in development and has not been cleared or approved by the FDA.