About OncoFirm™ Diagnostics
Advancing Research in Early Cancer Detection Technologies
OncoFirm™ Diagnostics is a research and development-stage cancer diagnostics company focused on advancing technologies for the detection and quantitative assessment of cancer-associated biomarkers.
Our research program integrates biomarker science, immunoassay development, fluorescence-based lateral flow technologies, optical reader systems, digital signal analysis, and computational methods to evaluate potential approaches for future cancer diagnostic applications.
OncoFirm™ technologies are currently under research and development. The performance characteristics of these technologies for clinical diagnostic use have not been established, and the technologies have not been cleared or approved by the U.S. Food and Drug Administration for clinical diagnostic use.
Our objective is to conduct the scientific, engineering, analytical, and clinical research necessary to determine whether these technologies may ultimately support future regulated diagnostic applications.
Our Research Mission
Translating Cancer Biomarker Science Into Testable Diagnostic Technologies
Cancer-associated biomarkers provide important opportunities for advancing the science of cancer detection and disease assessment.
OncoFirm™ Diagnostics is investigating technologies intended to help translate biomarker discoveries into reproducible diagnostic-test architectures capable of undergoing systematic analytical and clinical evaluation.
Our research focuses on the development and characterization of technologies that may potentially support future applications involving:
Detection of cancer-associated biomarkers
Quantitative biomarker measurement
Multi-analyte biomarker assessment
Point-of-care diagnostic technologies
Digital interpretation of lateral flow assays
Analytical quality-control systems
Computational evaluation of assay signals
Clinical research involving candidate diagnostic technologies
These potential applications remain subject to research, validation, applicable regulatory requirements, and FDA review or authorization where required.
Scientific & Technology Platform
OncoFirm™ Diagnostics is developing an integrated research platform encompassing multiple stages of diagnostic technology development.
Cancer Biomarker Research
OncoFirm™ investigates cancer-associated biomarkers and biomarker combinations that may warrant further evaluation for potential diagnostic applications.
Research activities may include:
Scientific literature assessment
Biomarker candidate selection
Antibody and binding-reagent evaluation
Antigen characterization
Assay feasibility testing
Biomarker-combination studies
Analytical characterization
Statistical analysis
Biospecimen research
Verification and validation planning
The identification of a cancer-associated biomarker does not independently establish clinical diagnostic utility. Candidate biomarkers require appropriate analytical and clinical evaluation before conclusions regarding diagnostic performance or clinical utility can be established.
Fluorescent Lateral Flow Technology
OncoFirm™ is researching fluorescence-based lateral flow assay technologies as a potential platform for sensitive and quantitative measurement of selected cancer-associated biomarkers.
Research areas include:
Fluorescent reporter particles
Antibody and reagent optimization
Antigen-antibody binding characteristics
Membrane selection
Conjugate optimization
Signal amplification approaches
Assay-flow characteristics
Test and control-line development
Background fluorescence management
Quantitative fluorescence measurement
Multiplex assay architectures
Calibration methods
Manufacturing reproducibility
These activities are intended to establish technical feasibility and generate data necessary for subsequent analytical and, where appropriate, clinical evaluation.
No representation is made that any research-stage assay can diagnose, screen for, rule out, predict, or monitor cancer unless and until such claims are supported by appropriate evidence and applicable regulatory authorization.
OncoFirm™ Digital Reader Research
OncoFirm™ is developing prototype electronic reader technologies for the measurement and analysis of fluorescence signals generated by compatible research-stage lateral flow assays.
Development activities may include evaluation of:
Optical excitation systems
Fluorescence detection
Digital image acquisition
Signal quantification
Background correction
Internal-control evaluation
Calibration procedures
Environmental compensation
Assay identification
Lot-specific information
Instrument quality controls
Electronic data capture
Test metadata management
Software-based signal processing
The reader platform is currently under development and has not been established as safe or effective for any clinical diagnostic purpose.
Artificial Intelligence & Computational Research
OncoFirm™ is investigating computational methods, including statistical modeling and artificial intelligence, as research tools for analyzing assay-generated information.
Potential research parameters include:
Fluorescence intensity
Signal distribution
Test-line characteristics
Background fluorescence
Internal-control response
Instrument measurements
Calibration information
Manufacturing-lot information
Environmental variables
Multiple biomarker measurements
The purpose of this research is to evaluate whether computational approaches may improve analytical interpretation, reproducibility, signal characterization, and quality assessment.
OncoFirm™ does not represent that an artificial intelligence model currently provides an independently validated cancer diagnosis or clinical recommendation.
Any future clinical application involving software or artificial intelligence would require appropriate verification, validation, clinical evidence, regulatory assessment, and FDA authorization where applicable.
Translational Development Strategy
OncoFirm™ is pursuing a staged research and development pathway intended to generate the evidence required to evaluate its technologies systematically.
Stage 1 — Scientific Research
Identification and evaluation of biomarkers, antibodies, reagents, fluorescent reporters, assay architectures, optical technologies, and computational approaches.
Stage 2 — Feasibility Development
Development of research prototypes and controlled laboratory experiments to determine whether proposed technical approaches demonstrate sufficient feasibility for additional investigation.
Stage 3 — Assay Optimization
Iterative evaluation of variables affecting analytical performance, potentially including reagent concentrations, antibodies, membranes, fluorescent reporters, assay geometry, optical conditions, calibration methods, and reader configurations.
Stage 4 — Analytical Evaluation
Research may evaluate characteristics such as:
Analytical sensitivity
Analytical specificity
Precision
Reproducibility
Linearity
Detection capability
Interference
Cross-reactivity
Stability
Lot-to-lot variability
Instrument variability
Testing parameters and acceptance criteria will depend upon the proposed device, its stage of development, and the intended research objectives.
Stage 5 — Clinical Research
Candidate technologies demonstrating sufficient analytical feasibility may progress to appropriately designed clinical investigations involving qualified research institutions, investigators, laboratories, Institutional Review Boards, and other parties as required.
Any clinical investigation would be conducted subject to applicable federal requirements, including applicable requirements concerning investigational devices, human-subject protection, informed consent, and IRB oversight.
Stage 6 — Regulatory Development
If research results support continued development, OncoFirm™ intends to evaluate the appropriate U.S. regulatory pathway for each device or technology in consultation with qualified regulatory professionals and, where appropriate, the FDA.
The applicable regulatory pathway will depend upon factors including the device’s intended use, technological characteristics, risk classification, predicate availability, and supporting evidence.
Grant-Supported Research Opportunities
Seeking Federal, Academic, Foundation & Industry Research Collaborations
OncoFirm™ Diagnostics actively seeks non-dilutive research funding and collaborative research opportunities to support scientific investigation and technology development.
Potential funding and collaboration areas include:
Cancer Biomarker Research
Research addressing identification, characterization, prioritization, and validation of cancer-associated biomarkers.
Immunodiagnostic Assay Development
Development and analytical characterization of antibody-based diagnostic technologies.
Fluorescent Detection Technology
Research involving fluorescent reporters, optical systems, signal enhancement, and quantitative measurement.
Point-of-Care Technology Research
Development of technologies intended to investigate whether complex biomarker measurements may ultimately be translated into decentralized testing formats.
Multi-Biomarker Research
Evaluation of combinations of biomarkers and analytical approaches for potential future diagnostic applications.
Digital Diagnostic Instrumentation
Development and evaluation of electronic readers, optical systems, calibration technologies, and associated software.
Artificial Intelligence & Computational Analysis
Research involving computational analysis of assay signals, biomarker data, reader measurements, and quality-control information.
Analytical Validation Research
Studies designed to characterize the analytical performance of candidate technologies.
Clinical Research
Appropriately controlled studies designed to evaluate candidate diagnostic technologies following analytical development and required regulatory and ethical review.
Manufacturing Science
Research addressing assay reproducibility, process controls, lot variability, reagent stability, calibration, and scalable manufacturing methodologies.
Federal Grant Opportunities
OncoFirm™ Diagnostics is interested in collaborative research and funding opportunities available through organizations and programs supporting cancer research and diagnostic technology development, including potential opportunities associated with:
National Institutes of Health
National Cancer Institute
NIH Small Business Innovation Research programs
NIH Small Business Technology Transfer programs
Federal translational research initiatives
Cancer research foundations
Academic research programs
State innovation programs
University-industry partnerships
Nonprofit cancer research organizations
Private research foundations
Industry-sponsored research
Reference to a federal agency or funding program does not imply endorsement, funding, sponsorship, or affiliation.
Eligibility and participation in any particular program are dependent upon the requirements of the applicable funding opportunity.
Academic & Clinical Research Collaboration
OncoFirm™ recognizes that development of regulated diagnostic technologies requires collaboration across multiple scientific and professional disciplines.
We welcome research discussions with:
Universities
Academic medical centers
NCI-designated and other cancer centers
Clinical laboratories
Oncology researchers
Cancer biologists
Pathologists
Immunologists
Molecular biologists
Biostatisticians
Bioinformaticians
Biomedical engineers
Clinical investigators
Biospecimen repositories
Biobanks
Contract research organizations
Regulatory specialists
Diagnostic technology developers
Medical-device manufacturers
Potential relationships may include:
Joint Grant Applications • Sponsored Research • Subawards • Contract Research • Biomarker Studies • Analytical Studies • Clinical Research • Technology Development • Statistical Analysis • Intellectual Property Licensing • Co-Development
The specific roles and responsibilities of collaborating organizations would be defined by the applicable research protocol, funding agreement, contract, or collaboration agreement.
Intellectual Property & Technology Collaboration
OncoFirm™ Diagnostics welcomes opportunities to evaluate complementary intellectual property and technologies that could support cancer diagnostic research.
Areas of potential interest include:
Cancer-associated biomarkers
Antibodies and binding agents
Antigen technologies
Fluorescent reporter systems
Signal amplification technologies
Immunoassay technologies
Lateral flow technologies
Biosensors
Optical detection systems
Digital diagnostic instruments
Signal-processing technologies
Artificial intelligence
Machine-learning methodologies
Diagnostic algorithms
Calibration technologies
Quality-control systems
Laboratory information technologies
Potential collaboration structures may include:
Licensing • Sponsored Research • Joint Development • Technology Evaluation • Research Collaboration • Intellectual Property Agreements • Commercial Development Agreements
Any technology considered for future clinical diagnostic use would remain subject to appropriate development, validation, and applicable regulatory requirements.
Building the Evidence Required for Translation
OncoFirm™ believes promising diagnostic concepts should progress through structured scientific evaluation before clinical claims are made.
Our research strategy therefore emphasizes the generation of objective evidence through:
Scientific Rationale → Feasibility → Prototype Development → Analytical Evaluation → Clinical Investigation → Regulatory Evaluation → Potential Commercialization
Advancement from one stage to another is dependent upon the results obtained during the preceding stage.
A research hypothesis or successful laboratory experiment should not be interpreted as establishing clinical safety, effectiveness, diagnostic accuracy, or clinical utility.
Potential Public Health Significance
Technologies capable of providing portable, reproducible, and quantitative biomarker measurements may warrant investigation for their potential to expand access to diagnostic testing.
OncoFirm™ is interested in researching technologies that, following appropriate validation and regulatory authorization, could potentially support healthcare environments including:
Hospitals
Cancer centers
Clinical laboratories
Physician offices
Outpatient facilities
Community healthcare settings
Rural healthcare systems
Underserved populations
Decentralized healthcare environments
These represent potential areas of future application and should not be interpreted as currently authorized indications for use.
Our Long-Term Research Vision
OncoFirm™ Diagnostics seeks to advance an integrated technology architecture connecting:
Cancer Biomarker Research → Immunoassay Development → Fluorescent Signal Detection → Digital Measurement → Computational Analysis → Quality Verification → Analytical Validation → Clinical Investigation
Our long-term objective is to determine whether these technologies can generate the scientific and clinical evidence necessary to support future regulated cancer diagnostic applications.
We believe this objective is best pursued through rigorous scientific research, multidisciplinary collaboration, appropriate regulatory planning, intellectual property development, and evidence-based decision-making.
Collaborate With OncoFirm™ Diagnostics
OncoFirm™ welcomes inquiries from investigators, universities, cancer centers, laboratories, government research programs, foundations, biotechnology companies, diagnostic developers, and other qualified organizations interested in collaborative research.
Areas of Interest
Grant Opportunities
Joint Research Projects
Academic Collaborations
Biomarker Research
Analytical Validation
Clinical Research
Technology Licensing
Intellectual Property Collaboration
Scientific Consulting
Regulatory Development
Diagnostic Technology Co-Development
Discuss a Grant or Research Opportunity
Contact OncoFirm™ Diagnostics to discuss potential research programs, grant applications, scientific collaborations, technology-development opportunities, or complementary intellectual property.
Important Regulatory Notice
OncoFirm™ Diagnostics’ technologies and product concepts described on this website are under research and development. Unless expressly identified otherwise, they have not been cleared, approved, or otherwise authorized by the U.S. Food and Drug Administration for clinical diagnostic use. Performance characteristics for clinical diagnostic use have not been established. Information presented on this website describes research objectives, technology-development activities, and potential future applications and is not intended to constitute claims of safety, effectiveness, diagnostic performance, or clinical utility. Any future clinical use will be subject to applicable validation, clinical, regulatory, and FDA requirements.
Research-Use Statement
Where a specific OncoFirm™ product is designated and distributed solely for laboratory research use, the applicable product labeling should be determined based on its actual intended use and development status and should comply with applicable FDA requirements.
FDA-defined Research Use Only (RUO) and Investigational Use Only (IUO) terminology should not be applied interchangeably and should only be used when the product and its actual intended use meet the applicable regulatory requirements.