Analytical performance of the FDA-cleared Parsortix^® PC1 system.

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.