Breast Cancer

Research Use Only – Not For Use In Diagnostic Procedures.

In my team’s research, we have demonstrated how circulating tumor cells harvested by this system are a good surrogate for tissue biopsies of the metastatic site. With this regulatory clearance we can now obtain repeat biopsies periodically to provide up-to-date information to guide treatment decisions, improving care and minimizing invasive procedures for these patients.”
Julie E. Lang, MD, FACS
Chief of Breast Surgery, Cleveland Clinic. Formally Director, USC Breast Cancer Program, Associate Professor of Surgery, Norris Comprehensive Cancer Center, University of Southern California
Breast Cancer is the most frequently diagnosed cancer in women, with 2.2 million new cases diagnosed globally in 2020 and 7.8 million women living with the disease. Despite new treatment options and advances in patient management protocols, 30% of women initially diagnosed with earlier stages of breast cancer will eventually develop recurrent advanced or metastatic disease. Although the prognosis of patients with metastatic breast cancer (MBC) has significantly improved, it remains largely incurable with a median survival time of only three years. Advancements in biopsy methodology for MBC are needed to improve patient monitoring and survival.

The current National Comprehensive Cancer Network (NCCN) guidelines and the Advanced Breast Cancer (ABC) consensus guidelines recommend that a solid tissue biopsy be taken at diagnosis and at cancer recurrence. Solid tissue biopsy confirms malignancy and tumor tissue receptor status which is clinically relevant to determine breast cancer subtype, clinical prognosis, and the choice of targeted therapy. However solid tissue biopsy is invasive, costly, time-consuming, potentially harmful, and is unsuitable for longitudinal monitoring. Tumor tissue may also be inaccessible or report a false negative if an insufficient sample is taken.

Circulating Tumor Cells (CTCs) obtained via liquid biopsies have significant potential for clinical decision making alongside current standard of care. This includes diagnosis and accurate prognosis, therapeutic target selection, monitoring treatment response and resistance, spatiotemporal monitoring of metastasis, and disease relapse.  Access to tumor cells from a peripheral blood sample can provide non-invasive, real-time monitoring of cancer patients and insight into clonal evolution during tumor metastasis and treatment.

In May 2022 the US FDA granted ground-breaking product clearance (De Novo Class II) for the Parsortix® PC1 Clinical System to harvest CTCs from MBC patient blood for subsequent, user-validated analysis. See: Intended Use

This submission included data in 421 participants (216 patients with metastatic breast cancer and 205 female healthy volunteers) from a multicenter study across four US cancer centers published in the journal Cancers in October 2022. This research demonstrated that it is possible to perform multiple downstream analyses on CTCs enriched using the Parsortix PC1 System. CTCs isolated from the peripheral blood of MBC patients were successfully evaluated by cytology (i.e., Wright-Giemsa staining), real-time quantitative reverse transcriptome PCR (qRT-PCR), RNA sequencing, and fluorescence in situ hybridization (FISH). See www.doi.org/10.3390/cancers14215238 for the full article.

In addition to ANGLE sponsored studies there are currently 24 peer-reviewed publications in breast cancer patients from 12 independent study centers in seven countries. Highlights from these include:

  • Breakthrough research by the Swiss Federal Institute of Technology (ETH), Zurich, found that the metastatic spread of breast cancer accelerates during sleep. See: nature.com/articles/s41586-022-04875-y
  • Research by the University of Southern California, Los Angeles, found high biomarker concordance between matched CTCs and metastatic tumor tissue biopsy. The authors conclude that RNA sequencing of CTCs could offer an alternative to tissue biopsy, providing clinically relevant insight into disease biology and druggable targets. See: pubmed.ncbi.nlm.nih.gov/35000083/

Collectively these studies have utilized a wide range of downstream analysis methods including DNA and RNA sequencing, PCR, and immunofluorescence to analyze a range of clinically actionable biomarkers such as EGFR, PIK3CA, HER2, ER, PR, and PD-L1.

Product Intended use:

The Parsortix® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood collected in K2EDTA tubes from patients diagnosed with metastatic breast cancer. The system employs a microfluidic chamber (a Parsortix cell separation cassette) to capture cells of a certain size and deformability from the population of cells present in blood. The cells retained in the cassette are harvested by the Parsortix PC1 system for use in subsequent downstream assays. The end user is responsible for the validation of any downstream assay. The standalone device, as indicated, does not identify, enumerate or characterize CTCs and cannot be used to make any diagnostic/prognostic claims for CTCs, including monitoring indications or as an aid in any disease management and/or treatment decisions.