Extending a collaboration launched last year, Celsee said it will commercialize a gene panel and several tests incorporating the single-cell diagnostic technology platform of IncellDx.
Under a co-marketing and development agreement whose value was not disclosed, Celsee and IncellDx plan to commercialize:
The companies began partnering last year through an immuno-oncology research collaboration launched to analyze the feasibility of using peripheral blood to perform IncellDx’s OncoTect iO Single Cell Quantitative programmed death-ligand 1 (PD-L1) assay on Celsee’s rare cell isolation and analysis platforms, designed to predict therapy response to metastatic cancers.
IncellDx’s technology is intended to enable simultaneous cell classification and single-cell analysis of proteomic and genomic biomarkers, while Celsee develops, manufactures, and markets integrated nanotechnology platforms for automated label-free isolation, analysis and retrieval of viable rare cells direct from blood.
The study analyzed PD-L1 expression in paired lung tumor biopsy and peripheral blood specimens using OncoTect iO as well as the Celsee C-Prep Genesis system. The study showed novel biomarker combinations predictive of CTCs were detected at an unprecedented level of single-cell resolution using Celsee C-Prep Genesis.
Genesis is part of Celsee’s C-Prep family of platforms, designed to enable single cell resolution facilitating the study of CTCs and individual cellular heterogeneity.
Celsee said the test also showed that several patient samples that exhibited minimal expression of PD-L1 in standard-of-care methods and would have resulted in a negative call, showed a positive expression for PD-L1 in CTCs using the combined two technologies.
After the companies followed up with deeper complex analysis, in which several isolated CTC cohorts were sequenced, the test showed allele frequency detection exceeding current levels of detection of critical markers targeted by current therapeutic interventions. Preliminary results from the study were presented at the Association of Molecular Pathologists (AMP) 2017 Annual Meeting, held in Salt Lake City.
“The initial efforts of this partnership clearly demonstrated the unprecedented combinational ability to accurately identify both critical protein and genomics markers at the single cell level that are undetectable with standard methods,” Celsee CEO John Stark said in a statement. “The coupled ability of IncellDx’s technology to generate single cell suspensions with Celsee’s technology to isolate and analyze single cells derived from peripheral blood and tissue will create a new standard for clinical research and for future diagnostic applications.”
Added IncellDx CEO Bruce Patterson, M.D.: “Our ongoing collaborative efforts have demonstrated that IncellDx’s quantitative, cell suspension based RNA in situ hybridization system with simultaneous protein and cell cycle detection assays exceeded expectations when performed on the Celsee system.
"IncellDx’s pre-analytic technology for generating single cell suspensions from solid tumors will expand the utility of the Celsee system from blood to identifying rare cells in solid tumors and quantifying minimum residual disease," Dr. Patterson added.