One platform. A family of cancer diagnostics.
From early detection to recurrence monitoring to smarter clinical trials, our technology unlocks a portfolio of high-value applications across the cancer continuum, all from a routine blood draw.
Designed for Clinical Translation
Every architectural choice — from sample volume to readout speed — was made with the clinic in mind. The result: faster iteration, broader applicability, and a clear path from research to regulated diagnostic.
Days, Not Weeks
Rapid sample-to-result turnaround versus weeks for sequencing-based approaches — enabling faster clinical decisions and faster trial iteration.
A Routine Blood Draw
Less than 1 mL of plasma per assay. Compatible with standard clinical collection — no special tubes, no large-volume draws.
Indication-Agnostic
The same instrument and protocol adapt across cancer types. Validated in colorectal and pancreatic cancer; breast cancer validation underway.
Digital, Quantitative, Reproducible
Single-molecule counting delivers absolute values — critical for regulatory submissions and consistent results across sites.
Layers On Top of ctDNA
An orthogonal signal that complements existing mutation panels — expanding clinical utility without replacing current workflows.
A Defensible Moat
Combinatorial nucleosome patterns — including bivalent signatures — provide biomarker features no bulk or sequencing-based approach can replicate.
Key Publications
Peer-reviewed research underpinning the EPINUC platform and single-molecule nucleosome analysis.
Single-molecule decoding of combinatorially modified nucleosomes
Science. 2016 May 6;352(6286):717-21.
doi: 10.1126/science.aad7701Multiplexed, single-molecule, epigenetic analysis of plasma-isolated nucleosomes for cancer diagnostics
Nature Biotechnology. 2023 Feb;41(2):212-221.
doi: 10.1038/s41587-022-01447-3Single-molecule systems for the detection and monitoring of plasma-circulating nucleosomes and oncoproteins in diffuse midline glioma
Cell Reports Medicine. 2025 Jan 21;6(1):101918.
doi: 10.1016/j.xcrm.2024.101918Regulatory Strategy
Parallel pathways — designed for early clinical access, accelerated FDA engagement, and deep pharma co-development.
Breakthrough Device Designation
Access the FDA BDD pathway for accelerated review, priority engagement, and potential agency guidance on data development.
CLIA / CAP Lab Pathway
A laboratory-developed test (LDT) strategy enabling early clinical access and revenue ahead of full IVD approval — a proven model in liquid biopsy.
Companion Dx Co-Development
FDA PMA or 510(k) pathways structured around pharma co-development — joint submissions aligned to therapeutic timelines.
Let's Build Something Together.
Whether you're a healthcare system, pharma company, or clinical research organization, we'd welcome a conversation about how our platform can add value to your work.
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