# Parsortix label-free circulating tumour cell harvest

Source: https://onco.cc/technologies/parsortix-ctc-harvest/  
OnCo record `parsortix-ctc-harvest` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A microfluidic cassette that traps cancer cells from blood by their size and stiffness rather than a surface marker, then releases them alive for testing; the first such device cleared in the United States, for metastatic breast cancer.

## Summary

What it does. Blood flows through a stepped microfluidic channel whose gaps narrow to a few micrometres. Large, stiff tumour cells are held in the steps while smaller, deformable blood cells pass. Reversing the flow releases the trapped cells intact, so they can be counted, stained, cultured or sequenced. Because the capture depends on physical properties rather than EpCAM, it also holds mesenchymal-like and cluster cells that antibody systems miss.

Regulatory status and evidence. In May 2022 the FDA granted De Novo authorisation to the Parsortix PC1 system for capturing and harvesting circulating tumour cells from the blood of patients with metastatic breast cancer for later analysis; it is CE marked in Europe. The clearance covers harvesting, not any specific clinical claim, so the downstream test decides what the cells mean. ANGLE, the developer, has built assays on the harvested cells for HER2, androgen receptor variants and DNA damage response markers and offers them as a service to pharmaceutical trials.

Who should have it and what changes. Nothing changes in routine care yet: harvested cells feed research and trial biomarkers rather than approved treatment decisions. Its promise is access to live tumour cells without a biopsy, for example to test protein targets that DNA cannot show, such as HER2 or oestrogen receptor on metastatic cells, and to grow cells for functional testing. Availability is through ANGLE's laboratories and partner sites; cost is that of a specialised research assay.

## Fields

- Kind: Technology
- Status: approved
- Last checked: 2026-09-17
- Also known as: Parsortix; Parsortix PC1; microfluidic CTC capture; size-based CTC enrichment
- Principle: Stepped microfluidic separation by cell size and deformability, with reverse-flow harvest of intact, unlabelled tumour cells for downstream staining, culture or sequencing.
- Since: 2022
- Strengths: Antibody-independent, so it catches cells that have lost EpCAM; Cells come out alive and unlabelled for any downstream test; FDA De Novo authorisation and CE mark for the harvest step
- Limitations: Clearance covers harvest only; clinical claims need separate validation; Low cell numbers in early-stage disease; Research and trial use rather than routine care

## Sources

- ANGLE plc: Parsortix system: https://angleplc.com

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- fronts: [Diagnostics & Biomarkers](https://onco.cc/fronts/diagnostics/)
- technologies: [CellSearch circulating tumour cell count](https://onco.cc/technologies/cellsearch-ctc-count/), [Circulating tumour cell capture](https://onco.cc/technologies/ctc-capture/), [Functional (ex vivo) drug testing](https://onco.cc/technologies/functional-drug-testing/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/)
- targets: [HER2](https://onco.cc/targets/her2/)
- companies: [ANGLE plc](https://onco.cc/companies/angle-plc/)
- terms: [AR-V7 splice variant](https://onco.cc/terms/ar-v7/)

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