A landmark scientific milestone confirming the clinical-grade performance of our OncoIncytes platform across 15+ tumour types and opening the door to transformative biopharma and academic partnerships.
Setting a New Standard in Oncology Diagnostics
We are proud to announce the successful completion of a rigorous CLIA-grade analytical validation study of our OncoIncytes 1080-Gene NGS Panel and proprietary iCare™ informatics pipeline, a milestone that marks a defining moment in our scientific journey and significantly strengthens the clinical credibility of our platform.
The study was conducted at the Georgia Cancer Center’s GEM Lab and led by Dr. Ravindra Kolhe, Professor and Chair of Pathology and Associate Director for Genomics at the Georgia Cancer Center: a recognised authority in translational genomics and one of the most respected names in the field.
What the Validation Study Demonstrated
The OncoIncytes 1080-gene NGS panel was put through its paces across a broad and rigorous set of performance criteria and the results speak for themselves:
- High concordance with FDA-approved orthogonal NGS platforms
- Consistent, reproducible performance across FFPE, blood, and bone marrow samples
- Coverage across 15+ tumour types, including lung, breast, GI, ovarian, and CNS malignancies
- Full interrogation of SNVs, CNVs, indels, fusions, and splice variants across key cancer genes
- Met all key performance thresholds set by CAP and AMP guidelines
“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 Power of iCare™ – AI at the Heart of Interpretation
What sets OncoIncytes apart is not just the breadth of its genomic panel, it is the intelligence layer that interprets it. Our proprietary iCare™ informatics pipeline combines AI-assisted variant classification with clinical interpretation, delivering scalable, accurate insights across diverse cancer types. Together, OncoIncytes and iCare™ form a tightly integrated system designed for real-world translational use.
Single-Cell Resolution – Unmatched Granularity for Oncology Research
At the core of our platform is our ability to evaluate multi-omic signatures on single live Circulating Tumor Cells (CTCs). The OncoIncytes Cell Biopsy® suite delivers simultaneous DNA, RNA, and protein analysis from just 20 mL of blood, providing real-time insights into tumour evolution, therapy response, and disease progression at a resolution no other platform can match.
“This milestone enables the translational use of the OncoIncytes 1080-gene NGS panel in exploratory biomarker discovery and patient stratification efforts,” said Dr. Gowhar Shafi, Chief Medical Geneticist at 1Cell.ai. “Our ability to evaluate multi-omic signatures on single live CTCs offers unmatched granularity for oncology research.”
What This Means for Biopharma and Academic Partners
This validation is not just a scientific achievement, it is a gateway to transformative partnerships. OncoIncytes is now offered for Research Use Only (RUO) applications through our CLIA-certified facility in Foster City, California, and we are actively inviting biopharma companies, academic institutions, and clinical trial investigators to connect with us for collaboration and assay access.
“OncoIncytes Cell Biopsy® suite delivers the promise of real-time, high-resolution insights from live tumour cells, powered by a simple blood draw,” said 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.”
Looking Ahead
The completion of this CLIA validation study is a crucial step in our mission to make precision oncology truly actionable at scale. With a validated, high-performance NGS panel, a CLIA-certified laboratory, and an AI-powered informatics pipeline, we are well-positioned to become the partner of choice for next-generation oncology research, drug development, and patient care.
Investigators and sponsors interested in study collaboration and assay access are encouraged to contact us.