Accurate Spike-in of Circulating Tumor Cells into Blood Samples is Essential for Reliable Analysis in Oncology Applications

Circulating tumor cells (CTCs) are the origin of distant cancer metastases and the ability to enumerate and analyze these cells has a great potential for diagnostic, prognostic and theragnostic applications in oncology. However, CTCs are very rare with only 1 CTC out of ten billion blood cells in a typical blood sample. To study these elusive cells, RareCyte has developed a proprietary sample preparation and analysis platform designed to count and analyze multiple biomarkers on CTCs. As part of analytical validation of enumeration accuracy, it is critical to generate surrogate blood samples with known numbers of model CTCs (mCTCs) at levels near the limit of detection for the assay. These studies require an accurate and precise number of spike-in samples performed in a reproducible manner which is not possible by either serial dilution or flow cytometry approaches.

For accuracy and precision studies, RareCyte uses the CellenONE^® single-cell isolation and dispensing technology which is best known for its use in single-cell analysis applications and cell line development. A customized sample deck was implemented into the cellenONE to accommodate both standard and RareCyte’s proprietary Blood Collection Tubes (AccuCyte^®) as well as microscope slides. Using automated cell image recognition, this technology ensures that every droplet dispensed into blood tubes always contains only one cell.

Tad George, SVP of Biology R&D at RareCyte, stated: “cellenONE is a versatile tool for high accuracy single cell deposition with nearly limitless substrate options. We are happy to utilize it for critical validation samples that require quantification of low count spike-in and recovery.” RareCyte’s liquid biopsy platform enables monitoring of circulating tumor cell count and biomarker expression, custom assay and companion diagnostics development, and the examination of cancer mutations in single CTCs.

Holger Eickhoff, CEO of SCIENION AG and Cellenion, stated: “RareCyte has developed a groundbreaking platform for next-generation analysis of circulating tumor cells. I am sure that liquid biopsies will considerably contribute to better diagnostics, treatment decisions and therapy monitoring in oncology. And of course, we are proud that our cellenONE single-cell dispenser has become an integral component of RareCyte’s validation process.”

For more information see the joint application note of RareCyte and Cellenion.

About RareCyte, Inc.

RareCyte offers Precision Biology solutions focused on multiplexed analysis of cells and tissue with applications in both research and clinical diagnostics. The company has deep experience in developing advanced precision life science systems used in cutting-edge labs worldwide. Our customers perform innovative research, bring new therapeutics to market, and perform a wide range of single cell applications in oncology and disease research.

About Cellenion

Cellenion offers solutions and technologies for controlled cell dispensing with applications in the fields of bioprinting and single-cell isolation. Cellenion has developed cellenONE^®, a unique single-cell isolation and dispensing technology. It allows high throughput automated dispensing of individual cells from cell suspensions onto any substrates of choice. With no dead volumes and outstanding recovery rates, this platform offers unique capacities for single-cell isolation from small biopsies and other clinical samples. Cellenion operates from Lyon, France. The company is a subsidiary of SCIENION AG and its cellenONE^® single-cell dispensers are sold by SCIENION worldwide.