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Analytical performance of the FDA-cleared Parsortix® PC1 system
Amy Templeman1, M Craig Miller2, Martin J Cooke1
1ANGLE Europe Limited, Guildford - UK.
Introduction:
The Parsortix® PC1 system, Food and Drug Administration (FDA) cleared for use in metastatic breast cancer (MBC) patients, is an epitope-independent microfluidic device for the capture and harvest of circulating tumor cells from whole blood based on cell size and deformability. This report details the analytical characterization of linearity, detection limit, precision, and reproducibility for this device.
Methods:
System performance was determined using K2-EDTA blood samples collected from self-declared healthy female volunteers (HVs) and MBC patients spiked with prelabeled cultured breast cancer cell lines (SKBR3, MCF7, or Hs578T). Samples were processed on Parsortix® PC1 systems and captured cells were harvested and enumerated.
Results:
The system captured and harvested live SKBR3, MCF7, and Hs578T cells and fixed SKBR3 cells linearly between 2 and ~100 cells, with average harvest rates of 69%, 73%, 79%, and 90%, respectively. To harvest ≥1 cell ≥95% of the time, the system required 3, 5 or 4 live SKBR3, MCF7 or Hs578T cells, respectively. Average harvest rates from precision studies using 5, 10, and ~50 live cells spiked into blood for each cell line ranged from 63.5% to 76.2%, with repeatability and reproducibility percent coefficient of variation (%CV) estimates ranging from 12.3% to 32.4% and 13.3% to 34.1%, respectively. Average harvest rates using ~20 fixed SKBR3 cells spiked into HV and MBC patient blood samples were 75.0% ± 16.1% (%CV = 22.3%) and 68.4% ± 14.3% (%CV = 21.1%), respectively.
Conclusions:
These evaluations demonstrate the Parsortix® PC1 system linearly and reproducibly harvests tumor cells from blood over a range of 1 to ~100 cells.
Insights
The Parsortix PC1 system effectively captures and harvests circulating tumor cells from blood samples. This microfluidic device demonstrates reliable performance for metastatic breast cancer diagnostics.
Area of Science:
- Biomedical Engineering
- Oncology
- Medical Diagnostics
Background:
- The Parsortix PC1 system is an FDA-cleared microfluidic device for capturing circulating tumor cells (CTCs) in metastatic breast cancer (MBC).
- It operates independently of cell epitopes, relying on cell size and deformability for CTC isolation from whole blood.
Purpose of the Study:
- To analytically characterize the linearity, detection limit, precision, and reproducibility of the Parsortix PC1 system.
- To evaluate the system's performance in capturing and harvesting CTCs from blood samples.
Main Methods:
- System performance was assessed using K2-EDTA blood from healthy volunteers and MBC patients.
- Blood samples were spiked with pre-labeled breast cancer cell lines (SKBR3, MCF7, Hs578T).
- Cells were processed, captured, harvested, and enumerated using the Parsortix PC1 system.
Main Results:
- The system demonstrated linear capture and harvest of live and fixed cells in the range of 2 to ~100 cells.
- Average harvest rates for live cells ranged from 69% to 90%, with high harvest efficiency for ≥1 cell (≥95% success rate).
- Precision studies showed %CV estimates for repeatability and reproducibility between 12.3% and 34.1%.
Conclusions:
- The Parsortix PC1 system exhibits linear and reproducible performance for harvesting circulating tumor cells.
- The system reliably isolates CTCs from blood samples within the evaluated cell concentration range.
- These findings support the utility of the Parsortix PC1 system in clinical applications for MBC patients.
