What are extracellular vesicles and why do they matter in cancer diagnostics?
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.
The ONCO Diagnostics platform, step by step.
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.
The unmet need in breast cancer therapy selection.
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.
Companion diagnostics and the pharma partnership opportunity.
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.
Why ONCO Diagnostics operates as an IP licensing entity.
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.