1Cell.Ai Marks Major Milestone with Successful CLIA Validation of OncoIncytes 1080-Gene NGS Panel

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

FOSTER CITY, Calif. — In a significant advancement for precision oncology, 1Cell.Ai has announced the successful completion of a CLIA-grade analytical validation study for its groundbreaking OncoIncytes 1080-gene NGS (Next Generation Sequencing) panel. This milestone was achieved in collaboration with the Georgia Cancer Center's GEM Lab, led by Dr. Ravindra Kolhe, a distinguished expert in translational genomics.

The study proved that the OncoIncytes panel exhibits a high level of concordance with existing FDA-approved NGS platforms and consistently demonstrates reliable performance across various sample types, including formalin-fixed, paraffin-embedded (FFPE) specimens, blood, and bone marrow. This validation spanned over 15 different tumor types, showcasing the panel's versatility and robustness.

Dr. Kolhe emphasized the importance of this validation, stating, "Our goal was to rigorously validate the OncoIncytes 1080-gene NGS panel across a broad spectrum of cancers and sample types. The panel met all key performance thresholds set by CAP (College of American Pathologists) and AMP (Association for Molecular Pathology) guidelines and is well-suited to support molecular profiling in research and clinical trial settings."

The OncoIncytes 1080-gene NGS panel is designed to analyze single nucleotide variants (SNVs), copy number variants (CNVs), insertions and deletions (indels), fusions, and splice variants across critical genes related to cancer. Coupled with 1Cell.Ai's proprietary iCare™ informatics pipeline, the platform promises an enhanced capability for scalable variant classification and interpretation across diverse cancer types, including lung, breast, gastrointestinal, ovarian, and central nervous system malignancies.

Dr. Gowhar Shafi, Chief Medical Geneticist at 1Cell.Ai, mentioned, "This milestone enhances the translational use of the OncoIncytes 1080-gene NGS panel in exploratory biomarker discovery and patient stratification efforts." He elaborated on the unique ability of the technology to evaluate multi-omic signatures on live circulating tumor cells (CTCs), providing an unprecedented level of detail for oncology research.

The OncoIncytes 1080-gene NGS panel is a part of the comprehensive OncoIncytes, Cell Biopsy® suite developed by 1Cell.Ai. This innovative platform delivers real-time insights into tumor evolution and therapy response by allowing simultaneous DNA, RNA, and protein analysis from just 20 mL of blood. As Mohan Uttarwar, CEO of 1Cell.Ai, pointed out, "The OncoIncytes Cell Biopsy® suite delivers the promise of real-time insights from live tumor cells powered by a simple blood draw.”

1Cell.Ai is already leveraging this platform by engaging with biopharma and academic partners, aiming to accelerate targeted therapy development, including antibody-drug conjugates (ADCs) and bispecifics, through more informed, data-driven patient selection processes.

Currently, OncoIncytes is available for Research Use Only (RUO) applications via 1Cell.Ai's CLIA-certified facility located in Foster City, California. The company invites investigators and sponsors interested in exploring collaborative studies to reach out for access to the assay.

About 1Cell.Ai

1Cell.Ai is paving the way for next-generation cancer diagnostics by combining patented single-cell multi-omics technology with advanced AI-driven biomarker discovery. This innovative approach establishes a new standard in precision oncology, focusing on providing insights at the single-cell level. For more information regarding the company and its initiatives, please visit 1Cell.Ai.