Celsee and IncellDx Sign Co-commercialization Agreement Following Successful Lung Cancer/CTC PD-L1 Feasibility Study
Minimal expression of PD-L1 in standard-of-care methods that would have resulted in a negative call showed a positive expression using the combined approach.
(January 10, 2018) Plymouth, MI– Celsee, Inc., an innovator of platforms for comprehensive single-cell identification, analysis and retrieval, announced today that they have entered a co-commercialization agreement with IncellDx, Inc., a single-cell diagnostic company offering a pioneering technology platform that enables simultaneous cell classification and single-cell analysis of proteomic and genomic biomarkers.
The statistically-significant feasibility study analyzed PD-L1 expression in paired lung tumor biopsy and peripheral blood specimens using two different molecular analysis technologies, the IncellDx OncoTect iO Single Cell Quantitative PD-L1 assay and the Celsee C-Prep Genesis. The PD-L1 protein allows some cancer cells to escape immune system attack by coupling with the PD-1 protein on T cells, instructing the T cell to leave the tumor cell alone. Checkpoint inhibitor drugs prevent this interaction and allow T cells to attack the tumor cells.
The study showed novel biomarker combinations that were predictive of circulating tumor cells (CTCs). These biomarkers were detected at an unprecedented level of single-cell resolution using the Celsee C-Prep Genesis system. A significant finding showed that several patient samples, which 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. Follow up with deeper complex analysis in which several isolated CTC cohorts were sequenced, demonstrated 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.
“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. In addition, 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,” stated Bruce Patterson, M.D., chief executive officer at IncellDx.
The co-market and development agreement have aligned the two organizations on commercializing the following clinical-grade solutions:
— 20 Marker Cell-by-Cell Lung Cancer Genomics and Proteomics Panel
— CTC Primary-Based Oncology Screen for breast, colorectal, prostate, and other cancers
— Cell-Based NIPT assay
“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. 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. The combinational ability to identify, quantify and define state at this level of detection at the individual cell level in both blood and tissue is currently out of reach with today’s commercial methods,” added John Stark, Chief Executive Officer at Celsee.
Each year 12.7 million people are diagnosed with cancer and 7.6 million people die from the disease. Other non-cancer cell-based diseases add to the incidence and death rate. Early detection by monitoring cells contributing to minimal residual disease at a single cell level has the potential to significantly improve the staging and potential treatment of these greatly impactful diseases.
Celsee, Inc. develops, manufactures, and markets integrated comprehensive single-cell analysis solutions that provide an unprecedented combinational ability to accurately identify, analyze and viably retrieve single cells directly from blood and tissue. Celsee’s platforms provide a practical approach to accurately analyze previously undetectable or rare cells to a scale of millions of single cells from an individual sample. The patented approach incorporates the fundamental properties of gravity for the gentle capture and isolation of individual cells from heterogeneous blood and tissue suspensions. Celsee’s comprehensive single-cell analysis platforms offer a practical solution for understanding and monitoring cell-based diseases.
IncellDx, Inc. is a single, cell-by-cell diagnostic company committed to advancing Precision Medicine by offering transformative diagnostic and prognostic clinical patient information based on an innovative technology platform that enables quantitative, simultaneous single-cell multiplex RNA in situ hybridization, protein analysis, and DNA cell cycle analysis. The company develops products designed to address pressing unmet clinical needs in the advancement of oncology and immuno-oncology in addition to its virology products. For more information, visit www.incelldx.com.