One Biosciences Announces Data Validating New Method for Single-Cell Transcriptomic Tumor Profiling from Clinical Pathology Samples

Sample-to-report workflow generating single-cell RNA expression profiles using routine FFPE pathology slides from four institutions validated across 88 specimens and six cancer types

One Biosciences, a techbio company pioneering clinical-grade single-cell tumor profiling, today announced data establishing that single-cell RNA expression profiles can be generated from the standard, formalin-fixed paraffin-embedded (FFPE) pathology specimens obtained in routine cancer care using the company’s proprietary platform, OneMap™.

The study, conducted with collaborators at Centre Léon Bérard, Hôpital Bichat–Claude Bernard, Institut Curie, and Memorial Sloan Kettering Cancer Center, was released as a preprint on BiorXiv.

“Every tumor is a unique ecosystem of many different types of cells, some cancerous, some not. Single cell profiling enables us to understand what those cells are, what they’re doing and potentially how that may impact treatment outcomes,” said Helena Yu, MD, thoracic medical oncologist at Memorial Sloan Kettering Cancer Center. “Until now that type of analysis required different types of samples and workflows than we deploy in clinical care. This study shows we can do that analysis from the same samples we already collect, paving the way to more deeply explore how we can leverage this technology to guide treatment.”

The study included multiple institutions from multiple regions and varied sample and tumor types to reflect the diversity encountered in real world clinical care. The data include findings from 88 single-nucleus experiments spanning bladder, breast, colon, lung, ovarian, and pancreatic cancers, including 36 core biopsies. The assay produced reproducible measurements of cellular composition and cell-type-resolved gene expression. Technical reproducibility was high (median correlation > 0.92 in cell-type proportions across replicates), and automated estimates of immune infiltration closely matched pathologists' assessments of tumor-infiltrating lymphocytes. The workflow succeeded on archival blocks up to roughly a decade old and on ultra-low-input biopsies, and it quantified clinically relevant antibody-drug-conjugate targets.

The assay uses single-nucleus RNA sequencing to measure gene activity inside individual cells present in thin slices of tissue prepared for standard pathologic analyses. OneMap™, an A.I.-powered software engine, identifies which cells are present and measures what each type is doing. OneMap™ then produces a single standardized report for each sample, eliminating the batch processing that older single-cell methods required.

"Single-cell analysis is a valuable addition to current molecular profiling, revealing important information about a tumor that standard tests cannot. Previously, it required the wrong kind of samples, too much tissue and analysis that only worked in large batches, making it impractical for real-world patient care," said Vincent Miller, executive chairman of One Biosciences. "This study validates our approach, which runs on ordinary pathology slides every hospital already produces, needs only a fraction of the tissue, and returns a standardized report for one patient at a time, creating a true sample-to-report solution that can enable more targeted clinical trials and ultimately improve patient care."

Standard tumor diagnostics average signal across millions of cells, potentially obscuring subpopulations of cells that might drive resistance, including immune cells. Single-cell profiling analyzes tumors one cell at a time, providing critical insights for both researchers and clinicians. Ongoing studies will explore whether single cell profiles can better select patients. In the clinic, single cell profiles offer an important addition to standard bulk profiling that grounds treatment decisions in the composition of a patient's own tumor.

About One Biosciences
One Biosciences is a single-cell transcriptomics company pioneering clinical-grade tumor profiling solutions. Founded in 2020 as a spin-off from Institut Curie, the company has developed OneMap™, an end-to-end single-cell molecular profiling platform, designed to help clinicians select optimal treatments for cancer patients and support pharmaceutical companies in the development of precision therapies and companion diagnostics. One Biosciences is supported by leading investors and partners including Redmile Group, Blast, Sofinnova Partners, Institut Curie, Gustave Roussy, and by the Paris-Saclay Cancer Cluster as part of its BOOST program. For more information, visit: www.onebiosciences.fr.

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