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WHAT IS IT?

Sentinel qCTC is a research-use-only liquid biopsy assay designed to detect and quantify circulating tumour cells (CTCs) in blood samples. CTCs are intact, living and circulating tumour cells that may enter the bloodstream after detaching from a primary tumour or metastatic site. By enabling sensitive measurement of these cells, Sentinel qCTC provides researchers with valuable insights into tumour biology, disease dynamics, and the potential role of CTCs as biomarkers. This technology is currently still intended for research purposes only and is not yet cleared for diagnostic use. However registration under the IVD directive is progressing.

The Test; (Coming Soon)

• Uses only a small 15 ml EDTA blood sample
• Is non-invasive and repeatable over time
• Samples are processed in a laboratory operating under ISO 15189 quality management principles for research sample handling.
• Is progressing towards registration as a CE marked medical device.

RESEARCH APPLICATIONS

POTENTIAL RESEARCH APPLICATIONS (INVESTIGATIONAL)
Sentinel qCTC is a highly sensitive, research use only liquid biopsy assay that detects and enumerates Circulating Tumour Cells (CTCs) in blood samples. These rare, living tumour cells can provide unique insights into tumour biology, disease progression and treatment response.

As part of ongoing research Sentinel qCTC is being explored for its potential to:

• Investigate whether CTC measurements correlate with disease changes at earlier timepoints compared to conventional assessments- research hypothesis under investigation.
• Generate research data on CTC dynamics during therapy, which investigators may use to explore correlations with treatment outcomes.
• Support longitudinal research studies examining CTC patterns during follow-up in research cohorts. Not for clinical remission monitoring.
• Generate data that may contribute to research exploring treatment response. Sentinel qCTC is not intended to inform or guide individual treatment strategy.

It applies to most solid epithelial tumours (e.g. breast, prostate, colon, lung).

While still under investigation, CTC analysis is being studied across a broad range of solid epithelial tumours (e.g., breast, prostate, colon, lung). For example, in breast cancer research, investigators are evaluating whether routine CTC monitoring (e.g. every 3–6 months) can offer insights into recurrence risk and help address patient concerns between scans.

RESEARCH VALIDATION BASIS

Sentinel qCTC builds on the foundation of a validated method that has been described in more than 100 peer-reviewed publications and investigated in ~30 clinical trials. This body of research demonstrates the potential of CTC analysis for:

• Detection of rare, single living tumour cells in blood has been demonstrated in research settings. Performance characteristics are under ongoing analytical and clinical investigation.
• Research data generation on CTC levels, which investigators may analyse in the context of minimum residual disease hypotheses. MRD utility is not validated for this assay.
• Published literature has reported associations between CTC counts and recurrence risk outcomes in research cohorts. Sentinel qCTC has not been validated as a predictor for individual recurrence risk.

Frontier is advancing this approach into Sentinel qCTC to support ongoing exploration of how living CTC measurements can contribute to a deeper understanding of cancer biology, treatment response, and disease dynamics.

To support researchers and clinicians in these studies, Sentinel qCTC will generate research data reports that include illustrated summaries designed to support investigator interpretation. Reports are for research use only and are not intended for direct patient communication or clinical decision-making.