ONCO Diagnostics owns, licenses, and provides specialty laboratory services around extracellular-vesicle–based diagnostic technology — generating quantitative, cell-specific tumor data at the point of biopsy to inform therapy selection for breast cancer patients without disrupting standard histopathology.
Why this mattersBreast cancer is the most commonly diagnosed cancer worldwide. When a patient is diagnosed, the first consequential decision — which therapy to pursue — is made using static biomarkers measured after tissue is preserved. These tests capture what the tumor looks like. They miss what it's actually doing.
Therapy choices made from static, post-fixation biomarkers.
Therapy choices informed by functional, in-vivo tumor signal.
The consequence is real: a meaningful share of patients receive first-line therapies that produce limited benefit — delaying access to interventions that might work, exposing patients to side effects, and consuming clinical time before the right therapy is identified. Functional tumor data, captured at the moment of biopsy, is built specifically to close that gap.
Read the full scienceConventional breast cancer diagnostics rely on static biomarkers measured after tissue fixation. ONCO's platform captures extracellular vesicles directly from living tumor tissue — preserving functional, in-vivo molecular signal that survives no other workflow.
During standard biopsy, fine needle aspiration, or lumpectomy, ONCO's assay isolates extracellular vesicles from the tissue interstitial fluid before formalin fixation. Because the EVs originate from live tumor cells in their native microenvironment, they carry functional protein and RNA signatures lost during conventional pathology workflows.
The result: a quantitative readout designed to support therapy-selection decisions equivalent to standard-of-care HER2 testing, with the potential to surface predictive signal that IHC and ISH cannot.
Six properties that distinguish ONCO's diagnostic from incumbent pathology assays and liquid-biopsy approaches — and that make it suitable for both clinical adoption and pharma companion-diagnostic partnerships.
Captures live-cell molecular activity — protein, RNA, lipid, glycan — rather than fixed-tissue biomarkers alone.
High/low scored values reported into hospital LIS for clinician decision-making, not qualitative interpretation.
Conducted on living excised tissue before formalin — accessing biology that downstream pathology destroys.
Integrates into existing biopsy and surgical pathology protocols — no new equipment, no patient-side disruption.
Compatible with mass spec proteomics, NGS, qPCR, lipidomics — flexible downstream analytical pathway.
Designed for pharma partnerships — pairing the test with therapeutic candidates to qualify responders.
ONCO's diagnostic slots into the moment a patient already produces tissue — biopsy, FNA, or stage-1 surgery — and returns therapy-selection data without delaying the standard pathology pipeline.
Standard diagnostic biopsy, FNA, or surgical lumpectomy — no change to the clinician's protocol.
Live-tissue interstitial fluid extraction with the ONCO kit. ~10 minutes, benchtop, pre-fixation.
CAP/CLIA-compliant analysis at the hospital pathology lab or via centralized reference partner.
Scored, quantitative result delivered through hospital LIS to the treating physician.
The licensed field of use is breast cancer therapy selection, with adjacent applications in treatment monitoring and pharma companion diagnostics. Expansion into other oncology indications is governed by ONCO Diagnostics on a case-by-case basis.
Quantitative tumor-cell data delivered at biopsy informs the choice between neoadjuvant regimens, targeted therapies, and standard-of-care interventions — supplementing HER2/ER/PR status with functional EV signal.
Serial sampling at follow-up biopsy or FNA can track functional tumor response to systemic therapy in real biological time.
Pair the assay with a pharma sponsor's targeted therapy to qualify responders and accelerate regulatory pathway under co-development.
Academic and reference laboratories may access the technology for biomarker discovery, in qualified non-commercial settings.
The underlying platform is tissue-agnostic. New indications are evaluated for licensing on a field-by-field basis with ONCO consent.
As a Contract Diagnostic Organization (CDO), ONCO Diagnostics provides EV-focused diagnostic development, clinical program support, regulatory filings, and kit manufacturing — delivered through our credentialed laboratory partnership at George Mason University. With all diagnostic services housed under a single roof, sponsors maintain one point of contact across the full development arc.
A credentialed clinical laboratory purpose-built to assess and evaluate new proteomic technologies under rigorous clinical guidelines, accelerate the verification and validation of promising candidate biomarkers in a clinical diagnostic setting, and implement unique clinical trials and diagnostic tests.
View the laboratory at GMU's Institute for Biohealth InnovationHigh-throughput protein array generation for biomarker discovery and validation across tissue and cellular samples.
Automated IHC processing of tissue and cellular samples for biomarker analysis under clinical-grade quality control.
Protein analyte measurement and clinical immunoassay testing for diagnostic validation and clinical trial sample analysis.
"We need EV capability for our specific program — not the underlying IP."
"We're building our own program on this IP — and need rights."
ONCO Diagnostics LLC is the controller of the underlying patent portfolio and know-how, sourced from George Mason University and exclusively licensed forward to commercial partners under field-and-territory terms.
The technology originated in academic research at George Mason University and was exclusively licensed to ONCO Diagnostics LLC under terms that preserve U.S. manufacturing requirements, milestone diligence, and downstream income participation by the originating institution.
ONCO Diagnostics retains limited rights for internal non-commercial research and the ability to license the underlying technology outside the breast-cancer therapy selection field. Within the licensed field, exclusivity flows to the commercial partner along with sublicensing rights into affiliates and channel partners.
Improvements, derivative works, and any new IP arising from licensee activity are governed by the definitive license agreement, with allocation between ONCO and licensee set at the time of grant.
The current exclusive license to Oncogenix covers breast cancer therapy selection in the United States and Canada only. Every other indication, every other geography, and every adjacent use of the technology remains available for licensing — and the underlying EV-isolation science applies across virtually any solid tumor.
The EV isolation method works on any solid-tumor biopsy or surgical specimen. The biology that makes it valuable in breast cancer — functional, pre-fixation tumor signal — extends to nearly every tumor type where biopsy is standard.
ONCO Diagnostics is actively pursuing partners for indications and territories outside the current Oncogenix grant — and for adjacent use cases such as therapy monitoring and pharma companion-diagnostic co-development.
Therapy selection · U.S. & Canada exclusively granted to Oncogenix Diagnostic Corp.
Therapy selection, treatment monitoring, and companion diagnostic co-development.
NSCLC and SCLC therapy selection, immunotherapy response prediction, companion Dx.
Adjuvant therapy selection, MSI/MSS profiling support, treatment monitoring.
Neoadjuvant therapy selection, surgical resection planning support.
Therapy selection, PARP inhibitor response prediction, recurrence monitoring.
Therapy selection, systemic therapy response, surveillance applications.
Therapy selection, HPV-associated subtyping, treatment response.
Targeted-therapy and immunotherapy selection, treatment response monitoring.
Therapy selection across emerging targeted and immune-based treatment regimens.
Muscle-invasive therapy selection and treatment monitoring applications.
Sarcoma, gastric, esophageal, brain, and additional indications — open to discussion.
Exclusive or non-exclusive rights for a defined cancer indication. Sublicensing optional. Royalty and milestone structure aligned with development stage.
Territory grants outside the United States and Canada — Europe, MENA, APAC, LATAM. Right-of-first-offer mechanics governed by existing agreements.
Pharma-sponsored arrangements pairing the assay with a therapeutic candidate. Suited to accelerated regulatory paths and patient-stratification trials.
Non-commercial access for academic translational research and biomarker discovery. Publication-friendly with limited royalty structure.
Time-bound exclusive evaluation period with right to convert to a full license — appropriate where licensee diligence requires technical evaluation.
Joint ventures, equity-linked arrangements, and bespoke structures considered for strategic partners with broader development commitments.
ONCO Diagnostics does not commercialize the technology directly. Development, manufacturing, and clinical commercialization sit with the licensee. Academic origin and exclusive commercial partner are shown below.
The underlying invention was developed within George Mason University laboratories. The GMU Research Foundation holds the original patent rights and licenses them exclusively to ONCO Diagnostics under continuing milestone and royalty obligations.
A British Columbia–based diagnostics company holding the exclusive license to the platform for breast cancer therapy selection across the United States and Canada. Developing the EV-based assay toward FDA 510(k) clearance and Canadian regulatory approval. Sublicensing into affiliates and commercial partners is contemplated.
A deeper look at the platform, the unmet need in breast cancer therapy selection, and the broader context for extracellular vesicle diagnostics in precision oncology.
Extracellular vesicles (EVs) are small, lipid-bilayer-enclosed particles released by virtually every cell in the human body. Typically 30 to 150 nanometers in diameter, EVs carry a cargo of proteins, messenger RNA, microRNA, lipids, and metabolites that reflects the molecular state of the cell that produced them. In oncology, the EVs released by tumor cells offer a window into tumor biology that is otherwise difficult to access — a real-time biochemical signature of how a cancer is actually behaving, not just what it looks like under a microscope.
EV-based diagnostics use the molecular content of these vesicles to make clinical inferences: what a tumor is, how it is likely to respond to a given therapy, and how it is evolving over time. Most commercial efforts to date have focused on isolating EVs from peripheral blood — the so-called liquid biopsy approach. ONCO Diagnostics' platform takes a different and complementary path: isolating EVs directly from the tissue interstitial fluid at the time of biopsy, before any preservation or fixation step degrades the signal.
At the time of standard-of-care diagnostic biopsy, fine needle aspiration, or surgical lumpectomy, the excised tissue is placed in ONCO's interstitial fluid collection device. Through a brief, low-force separation step, the device extracts the fluid that surrounds living cells within the tumor — interstitial fluid that is rich in extracellular vesicles released by tumor cells in their native microenvironment. The entire extraction takes under ten minutes on a standard benchtop centrifuge, and crucially, leaves the tissue fully intact for the histopathology workflow that follows.
The extracted EVs are then analyzed using established molecular assays — mass spectrometry, qPCR, next-generation sequencing, immunoassays, or combinations thereof — to produce a quantitative readout of the markers relevant to therapy selection. Results are reported as numerical scores with high and low thresholds, integrating into the hospital laboratory information system the same way HER2 or estrogen-receptor results currently do.
The platform's reproducibility, demonstrated in early validation work with coefficients of variation under 10 percent across replicate samples, and its compatibility with standard CAP and CLIA accredited laboratory environments make it suitable for both centralized reference-laboratory deployment and decentralized point-of-care clinical use.
Breast cancer is the most commonly diagnosed cancer worldwide and the leading cause of cancer mortality among women in many regions. Treatment decisions today rely on a standard set of biomarkers — estrogen receptor, progesterone receptor, HER2, and Ki-67 — measured by immunohistochemistry or in-situ hybridization on fixed tissue. These tests are validated, reimbursed, and effective, but they tell clinicians only part of the story.
Static biomarker measurements taken after tissue fixation cannot capture the functional state of tumor cells: which signaling pathways are active, how cells are responding to their microenvironment, and which therapies the tumor is biologically primed to respond to. As a result, a significant proportion of patients receive therapies that produce limited benefit, delaying access to interventions that might actually work and exposing them to unnecessary side effects.
A diagnostic that captures functional, pre-fixation tumor signal — in a workflow that adds no patient burden and integrates seamlessly with existing biopsy procedures — has the potential to meaningfully improve first-line therapy decisions, particularly in the neoadjuvant setting where therapy choice is most consequential.
A companion diagnostic is a test used to identify patients most likely to benefit from a particular therapeutic product. Companion diagnostics are increasingly central to modern oncology drug development — and to drug commercialization, where payers increasingly require evidence of biomarker-defined patient selection.
ONCO Diagnostics' platform is well-suited to companion diagnostic development because it produces quantitative, reproducible signal directly from tumor tissue at the decision point. Pharmaceutical partners pursuing targeted therapies, immunotherapies, or combination regimens can pair the assay with their therapeutic candidate to qualify responders, support biomarker-driven clinical trials, and potentially accelerate regulatory pathways under FDA companion-diagnostic frameworks.
Co-development arrangements typically combine upfront payments, development milestones tied to regulatory progress, and royalty interests on the resulting test or paired therapeutic. ONCO Diagnostics welcomes inquiries from pharma BD teams pursuing patient-stratification opportunities in any solid tumor indication.
ONCO Diagnostics LLC was structured specifically as a holding and licensing entity rather than a vertically integrated operating company. This structure exists because the underlying platform technology has applicability far broader than any single commercial program could pursue alone.
By concentrating IP ownership in ONCO Diagnostics and licensing forward to specialized commercial partners on a field-and-territory basis, the platform can be developed in parallel across multiple cancer indications and geographic markets — with each licensee deploying the focus, capital, and regulatory expertise appropriate to its specific commercial scope. The structure also provides a clean chain of title for potential investors, partners, and acquirers, with clear delineation of which rights sit where.
Inquiries about field-of-use licenses, geographic expansion, companion-diagnostic co-development, research-use access, or strategic arrangements should be directed to licensing@oncodiagnostics.com.
Answers to the questions most often raised by pharmaceutical business development teams, reference laboratories, academic researchers, and prospective licensing partners.
ONCO Diagnostics welcomes inquiries from pharmaceutical companies, reference laboratories, and academic groups interested in the platform — within or outside the currently licensed field. We respond to all serious inquiries within five business days.