Applications
CTC-Based Liquid Biopsy

Circulating tumor cells (CTCs) are the origin of distant cancer metastases, which are responsible for most cancer-related mortality. Circulating tumor cell count is associated with prognosis and response to therapy, and analysis of circulating tumor cells allows investigation of cancer cell biomarker expression and mutational status from a non-invasive liquid biopsy.

RareCyte® enables practical deployment of circulating tumor cell-based liquid biopsy with instrumentation and consumables that provide an exquisitely sensitive, accurate, reproducible, and transparent workflow from blood collection to single-cell isolation.


The RareCyte platform enables:

  • Monitoring circulating tumor cell count and biomarker expression over time for clinical research
  • Custom assay and companion diagnostics development through our Pharma Programs 
  • Cancer-specific and Developer panels for your biomarkers
  • Examination of cancer mutations in single circulating tumor cells

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Uniquely RareCyte

The RareCyte platform provides:

  • Reproducibility: End-to-end workflow designed for consistent results in multi-site deployment settings common to large clinical research studies
  • Flexibility: Three-day blood sample stability and bank-before-stain option enables practical clinical sample shipping, staining, and analysis pipelines
  • Sensitivity: Unbiased and highly sensitive target cell recovery with the AccuCyte® Sample Preparation System
  • Specificity: Up to six-channel fluorescence imaging with machine learning-enabled circulating tumor cell detection protects against false positives
  • Validated panels: RarePlex® Staining Kits for research use designed for circulating tumor cell identification and biomarker expression analysis
  • Retrieval: Gentle, single cell isolation for nucleic acid analysis



RareCyte panels for liquid biopsy analysis include markers used for circulating tumor cell identification and biomarker exploration. Circulating tumor cells are identified as nucleated cells that express CK/EpCAM but not CD45. The breast assay used the RarePlex HER2/ER CTC Panel Kit and the prostate assay used the ARv7 CTC Panel Kit and a Developer Kit for AR. With Developer technology, you can customize your panel with up to two of your own biomarkers.
Image gallery of spike-in model circulating tumor cells surrounded by white blood cells on AccuCyte slides. Nuclei (magenta) / CK/EpCAM (green)
RarePlex® Panel and Developer Assays for CTC enumeration and characterization
Presented by Arturo Ramirez, Ph.D., Director of Oncology R&D
This 7 minute overview of RarePlex Panel Kits and Developer technology highlights available circulating tumor cell assays from RareCyte and presents an introduction to our assay design and validation.


RarePlex® Assays: Design and Analytical Validation
Presented by Dr. Tad George, Sr. VP of Biology R&D
RarePlex Assays are sensitive, specific, and reproducible assays for CTC detection and biomarker expression. Gain insight into the principles RareCyte applies to its assay design and validation process in this 11 minute video.

WEBINAR: Analytical Validation of CTC Enumeration using the RareCyte Platform and Implementation in a Global Clinical Trial

This webinar describes how the RareCyte platform for CTC analysis was validated in the Clinical Diagnostics Lab (CAP accredited CLIA Lab) at Eli Lilly. The results met the requirements of the Clinical Drug Study Team and the RareCyte platform was added to a global clinical trial for further evaluation in collaboration with a CRO. A short presentation on RareCyte CTC assays for enumeration, multi-biomarker analysis, and custom assay development capabilities follows.

Speakers:
Jeff Fill, MBA, MT(ASCP), Senior Director, Diagnostic and Experimental Pathology, Lilly Research Laboratories, Eli Lilly and Company
Arturo Ramirez, PhD, Director of Oncology, RareCyte, Inc.


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The Complete Picture: Cell free and single circulating tumor cell sequencing from a single tube

RareCyte’s circulating tumor cell assays and CyteFinder Instrument can be paired with CleanPlex® NGS Technology from Paragon Genomics to reliably measure somatic mutations from single circulating tumor cells and plasma. RareCyte assays deliver repeatable and accurate circulating tumor cell counts, biomarker expression, and plasma – all from a single tube of blood. Single cells can be retrieved from the slides and deposited into PCR tubes using the CytePicker Retrieval Module. CleanPlex Panels deliver consistent sequencing results from plasma and single cell inputs, without the need for whole genome amplification.

Read more about a case study examining HER2 genetic heterogeneity in a metastatic breast cancer patient.