1Cell.Ai is a precision oncology company built around the single cell multi omic cell biopsy®: profiling DNA, RNA, and protein from individual circulating tumor cells so pharma and clinical teams can select the right patients, validate ADC targets, and catch resistance that tissue IHC and bulk ctDNA average away.
1Cell.Ai, formerly OneCell Diagnostics, was founded in 2021 and rebranded in 2025 with the launch of its OncoIncytes® platform, following an oversubscribed $16M Series A. The company's premise is that most targeted therapies still select patients from a single marker, on a single slice of tissue, frozen at a single point in time, while the biology that decides response and resistance lives in individual cells no one profiled. Its cell biopsy® approach captures live circulating tumor cells from a standard blood draw and reads DNA, RNA, and protein from the same cell.
The platform resolves driver mutations and copy number alterations at single cell resolution, reads pathway activity at the RNA level, and quantifies 20 to 30 ADC targets per cell with oligo tagged antibodies, including Trop-2, HER2, PSMA, Nectin-4, DLL3, and FRα. Sequencing runs on a 1,080 gene panel validated at 100% concordance against Illumina's TSO 500 and the FDA cleared PGDx panel. Cell biopsy® works alongside ctDNA rather than replacing it, with both read from the same 10 mL blood draw, which is how the company positions itself as the third generation after tissue and liquid biopsy.
1Cell.Ai operates a CLIA and CAP certified laboratory in Foster City, California, with additional operations in Mumbai and Pune, India. Its clinical advisory board is chaired by Nobel Laureate Dr. James Rothman. The company presented seven studies at AACR 2026, was featured at ASCO 2026, and has validated its platform across 2,062 patient samples spanning more than nine cancer types. Active programs span ADC biomarker development, bispecific target validation, clinical trial enrichment, precision oncology, and translational research.
The multi omic cell biopsy® platform: live CTC and ctDNA analysis, one cell at a time, for comprehensive molecular insight across DNA, RNA, and protein.
An AI driven single cell isolation and analysis system for high resolution research in oncology and drug development.
Integrated AI analytics that unify complex multi omic data across clinical trials and precision oncology studies.
Tissue and ctDNA answer part of the question. The company positions cell biopsy® as the only approach delivering repeatable, single cell DNA, RNA, and protein from live, intact tumor cells:
Cell biopsy® works alongside ctDNA rather than replacing it: both are read from the same 10 mL blood draw.
Results from presented studies and validated cohorts, as reported by the company:
Clinical advisory board chaired by Nobel Laureate Dr. James Rothman.
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