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    Precision Oncology · Cell Biopsy®

    Beyond Liquid Biopsy.Welcome to Cell Biopsy®

    The next generation of precision oncology starts with living tumor cells.
    True single-cell multi-omics for a deeper view of tumor biology.

    What is Cell Biopsy®?

    Cell Biopsy® captures live circulating tumor cells (CTCs) to enable single-cell analysis of tumor biology. Integrating DNA, RNA, protein, and matched ctDNA, it provides a multidimensional view of tumor characteristics.

    The Problem

    An Average
    Is Not a Patient’s Biology

    Tumors are not uniform. They are dynamic ecosystems made up of diverse cellular populations with distinct genetic, transcriptomic, and proteomic profiles.

    Population-level measurements can average away critical differences, potentially obscuring rare cell populations, evolving clones, resistance-associated biology,
    and therapeutic target expression.

    Tumor evolution is reflected at the cellular level.

    The Category

    From Tissue to Cells

    The way we study cancer is evolving. From tissue biopsy to liquid biopsy to Cell Biopsy®, each approach provides a different window into tumor biology—with cellular resolution offering a deeper view of tumor heterogeneity and evolution.

    Tissue Biopsy

    A static view of tumor biology.

    Liquid Biopsy

    A minimally invasive view of tumor biology through circulating tumor DNA.

    Cell Biopsy®

    A cellular view of tumor biology.

    New category

    We see cancer, one cell at a time.

    Moving beyond fragments to understand the biology of intact circulating tumor cells.

    True Single-Cell Multi-Omics

    Three Molecular Layers. One Cell.

    Measure DNA, RNA, and protein at the level of individual tumor cells—
    preserving biological differences that population-level analysis can miss.

    DNA What has changed?

    Genomic alterations and genomic instability.

    RNA What is being expressed?

    Transcriptomic activity and molecular programs.

    Protein What is present?

    Protein expression and biomarker profiles.

    True single-cell multi-omics characterizes multiple molecular layers at the level of individual tumor cells, preserving biological heterogeneity that population-level analysis can obscure.

    DNA, RNA AND PROTEIN FROM THE SAME SINGLE CELL

    From molecular averages to
    cellular resolution

    Investigate the cellular populations underlying tumor heterogeneity,
    clonal evolution, therapeutic resistance and target expression.

    THE PLATFORM

    OncoIncytes®

    Powering Cell Biopsy®

    OncoIncytes® is our proprietary technology platform designed to capture live circulating tumor cells and integrate DNA, RNA, protein, and matched ctDNA—enabling a deeper, single-cell view of tumor biology.

    THE INTELLIGENCE LAYER

    From Cells to Insights, Faster

    iCore turns incoming biological data into analysis-ready insights—without the traditional data-wrangling burden.

    Research teams often spend months organizing and harmonizing siloed omics, imaging, and clinical data before analysis can begin. iCore brings these data sources together, automates quality control and harmonization, and enables plain-language queries across studies—helping teams move from data to scientific insight faster.

    Accelerated Assay Development

    Move from study design to assay execution without building a bioinformatics workflow from scratch.

    Rapid Validation & Feasibility

    Evaluate pilot cohorts early and make informed decisions without waiting for a full study.

    Analysis-Ready on Upload

    Automated QC, harmonization, and cross-study querying begin as data arrives.

    Less data wrangling.
    More time for science.

    Built with 21 CFR Part 11, HIPAA, & GDPR compliance in mind from day one.

    APPLICATIONS

    Where Cell Biopsy® Creates Impact

    From understanding tumor biology to advancing new therapies, Cell Biopsy® supports research across the precision oncology continuum.

    Drug Development

    Characterize biomarkers, therapeutic targets, and mechanisms of resistance to inform drug development.

    Translational Research

    Investigate tumor biology at single-cell resolution and connect molecular insights to translational research.

    Target Validation

    Measure target expression directly on live circulating tumor cells using fresh blood samples from cancer patients.

    Biomarker Discovery

    Explore tumor heterogeneity, target expression, and emerging resistance to uncover potential biomarkers.

    CASE STUDY · EGFRm NSCLC

    Finding Resistance That ctDNA Alone Can Miss

    Baseline detection of EGFR bypass-pathway mutations in individual circulating tumor cells was associated with early TKI resistance and shorter overall survival, revealing resistance-associated biology not captured by ctDNA alone.

    Clinical context

    TKI therapy is a standard treatment approach for EGFR-mutant NSCLC, yet resistance can emerge through bypass-pathway alterations that may be undetectable in bulk ctDNA.

    ASSAY ADVANTAGE

    OncoIncytes® detects bypass-pathway mutations in single circulating tumor cells at baseline, capturing private and subclonal variants that may be diluted or missed in bulk ctDNA analysis.

    KEY FINDING

    In a pilot cohort of 60 patients, 15 carried a single-cell TKI resistance signature. Patients with the signature experienced earlier progression and shorter overall survival, supporting the potential of single-cell resistance profiling for earlier patient stratification.

    Overall survival by mutation signature

    4.3×

    Hazard ratio for death

    95% CI 2.7–7.5

    0.0005

    P-value

    Log-rank test

    9.3mo

    Median PFS with
    resistance signature

    25%

    Resistance rate

    15 of 60 patients

    Pilot study, homogeneous EGFR-mutant NSCLC cohort (n = 60). OncoIncytes® CTC + ctDNA.

    SCIENCE

    Built on Science.
    Grounded in Real-World Data.

    Our work spans circulating tumor biology, single-cell analysis, multi-omics, and AI-enabled analytics—from technology development and validation to translational research. Our platform has been evaluated with clinicians and academic partners across the US, Europe, and India.

    2,400+

    Samples Processed

    Patient samples processed through the platform across studies in the US, Europe, and India.

    85%

    CTC Positivity Rate

    CTCs detected across diagnosed patients with stage II–IV disease, spanning eight cancer types.

    ~100%

    Metastatic Capture Rate

    Circulating tumor cells recovered from nearly every metastatic sample analyzed.

    20+

    Targets from a Single Cell

    Quantitative protein expression measured across ADC and TCE targets using oligo-tagged antibodies.

    TESTIMONIAL

    Advancing the Next Generation of Precision Oncology

    It has been a pleasure to work on this project and with this really interesting technology. By bringing together CTCs and ctDNA at the single-cell level, this platform provides a high-level understanding of what is happening in patients, offers better clonal resolution, and enables longitudinal tracking of cancer evolution. I think this is really next-generation precision oncology.
    Dr. Razelle Kurzrock 
    Associate Director of Clinical Research, Medical College of Wisconsin Cancer Center

    COMPANY

    Pioneering a New View of Cancer Biology

    1Cell.AI is building the technology foundation for a more precise view of cancer—moving beyond population-level molecular averages toward live, cell-resolved tumor biology.

    28

    Clinical Studies

    Across 3 continents

    102

    ASCO · AACR · ESMO · ISLB

    Scientific presentations across leading oncology and pathology conferences.

    5

    Peer-Reviewed Articles

    Published research, with 9 additional manuscripts in preparation.

    8

    Patent Families

    Granted and filed patent families supporting our technology platform.

    20+

    Trademarks

    Trademarks filed across our technology and product portfolio.

    55 ASCO · 33 AACR · 4 ESMO · 10 ISLB, across the world’s leading oncology congresses,
    with a studies and KOL network spanning leading cancer centers.

    STRATEGIC PARTNERSHIPS

    Collaboration That Moves
    Precision Oncology Forward

    get started

    Precision Oncology Starts at the Cell

    Discover how 1Cell.Ai is bringing true single-cell multi-omics to oncology research, drug development and translational medicine.

    1Cell.Ai
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