1Cell.Ai Completes CLIA Validation Study of OncoIncytes 1080-Gene NGS Panel

FOSTER CITY, Calif., May 28, 2025 /PRNewswire/ -- 1Cell.Ai, a precision oncology company developing advanced cell and molecular profiling platforms, announced the successful completion of a CLIA-grade analytical validation study of its OncoIncytes 1080-gene NGS panel and proprietary iCare™ informatics pipeline at the Georgia Cancer Centre's GEM Lab. The study was led by Dr. Ravindra Kolhe, Professor and Chair of Pathology and Associate Director for Genomics at the Georgia Cancer Center, and a recognized authority in translational genomics.

The OncoIncytes panel demonstrated high concordance with FDA approved orthogonal NGS platforms and consistent performance across FFPE, blood, and bone marrow samples spanning over 15 tumor types.

"Our goal was to rigorously validate the OncoIncytes 1080-gene NGS panel across a broad spectrum of cancers and sample types," said Dr. Ravindra Kolhe. "The panel met all key performance thresholds set by CAP and AMP guidelines and is well-suited to support molecular profiling in research and clinical trial settings."

The OncoIncytes 1080-gene NGS panel interrogates SNVs, CNVs, indels, fusions, and splice variants across key cancer genes. Combined with the AI-assisted iCare™ pipeline, the system provides scalable variant classification and interpretation across diverse cancer types, including lung, breast, GI, ovarian, and CNS malignancies.

"This milestone enables the translational use of OncoIncytes 1080-gene NGS panel in exploratory biomarker discovery and patient stratification efforts," said Dr. Gowhar Shafi, Chief Medical Geneticist at 1Cell.Ai. "Further, our ability to evaluate multi-omic signatures on single live CTCs offers unmatched granularity for oncology research."

The 1080-gene NGS panel is part of 1Cell.Ai's proprietary OncoIncytes, Cell Biopsy® suite—a comprehensive platform that enables true single-cell resolution of live CTCs and integrates multi-omics profiling. The platform delivers simultaneous DNA, RNA, and protein analysis from just 20 mL of blood—offering real-time insights into tumor evolution and therapy response.

OncoIncytes Cell Biopsy® suite delivers the promise of real-time, high-resolution insights from live tumor cells, powered by a simple blood draw." added Mohan Uttarwar, CEO of 1Cell.Ai. "As we engage with biopharma and academic partners, the platform is poised to accelerate the development of targeted therapies, including ADCs and bispecifics, through smarter, data-driven patient selection."

OncoIncytes is offered for RUO applications through 1Cell.Ai's CLIA-certified facility in Foster City, California. Investigators and sponsors are encouraged to connect for study collaboration and access to the assay.

About 1Cell.Ai
1Cell.Ai is a precision oncology company pioneering the next generation of cancer diagnostics through patented single cell multi-omics and cell biopsy technology. By combining groundbreaking science with AI-enabled biomarker discovery, 1Cell.Ai creates a new standard in precision oncology at the single cell level. For more information, visit www.1Cell.Ai.

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www.1cell.ai

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SOURCE 1Cell.Ai