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

Autor: Templeman A; ANGLE Europe Limited, Guildford - UK., Miller MC; ANGLE North America, Inc., Plymouth Meeting, PA - USA., Cooke MJ; ANGLE Europe Limited, Guildford - UK., O'Shannessy DJ; ANGLE North America, Inc., Plymouth Meeting, PA - USA.; TMDx Consulting LLC, Schwenksville, PA - USA., Gurung Y; ANGLE Europe Limited, Guildford - UK., Pereira T; ANGLE Europe Limited, Guildford - UK.; Whitings LLP, Ramsey - UK., Peters SG; ANGLE Europe Limited, Guildford - UK.; Petmedix, Cambridge - UK., Piano M; ANGLE Europe Limited, Guildford - UK., Teo M; ANGLE Europe Limited, Guildford - UK.; Royal Berkshire NHS Foundation Trust, Bracknell - UK., Khazan N; University of Rochester Medical Center, Rochester, NY - USA., Kim K; University of Rochester Medical Center, Rochester, NY - USA., Cohen E; MD Anderson Cancer Center, Houston, TX - USA., Lopez HB; MD Anderson Cancer Center, Houston, TX - USA., Alvarez F; MD Anderson Cancer Center, Houston, TX - USA., Ciccioli M; ANGLE Europe Limited, Guildford - UK., Pailhes-Jimenez AS; ANGLE Europe Limited, Guildford - UK.
Jazyk: angličtina
Zdroj: Journal of circulating biomarkers [J Circ Biomark] 2023 Aug 07; Vol. 12, pp. 26-33. Date of Electronic Publication: 2023 Aug 07 (Print Publication: 2023).
DOI: 10.33393/jcb.2023.2629
Abstrakt: 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 K 2 -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.
(Copyright © 2023, The Authors.)
Databáze: MEDLINE
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