TEST:

CELLSEARCH®

PTEN loss appears to represent an early molecular alteration associated with adverse pathological features. Longer follow-up is needed to determine the predictive value of these biomarkers for recurrence and long-term outcomes.

When integrated with rVAR2-FETCH enrichment, our platform detected CTC in 83.67% (41/49) of non-small cell lung cancer patients, outperforming the complete CellSearch kit. Furthermore, machine learning models integrating CTC counts with hematological biomarkers achieved excellent diagnostic performance for lung cancer, with support vector machine demonstrating the best results (AUC = 0.977).

High CTC counts may potentially predict inferior outcomes after salvage lymph node dissection. As high counts are rare in early oligorecurrent PC, more sensitive CTC technologies and additional biomarkers are needed. The BioPoP study is registered on ClinicalTrials.gov as NCT04324983.

P=N/A, N=130, Recruiting, Institute of Oncology Ljubljana

P1/2, N=37, Active, not recruiting, Weill Medical College of Cornell University | Recruiting --> Active, not recruiting | N=76 --> 37

CTC-negative status predicted longer OS and PFS, while CAM-L positivity at T1 was associated with improved outcomes, particularly in ICI-treated patients. Combined assessment of both biomarkers may directly inform therapeutic decision-making, through early detection of outcomes.

P=N/A, N=27, Completed, Institut Claudius Regaud | Active, not recruiting --> Completed | Trial completion date: Sep 2025 --> Jan 2026 | Trial primary completion date: Sep 2025 --> Jan 2026

These findings support the hypothesis that volatile anesthetics may reduce short-term recurrence risk and warrant larger, longer-term trials to validate oncological outcomes.

These results support the clinical utility of HER2 assessment on CTCs with both workflows and highlight the potential diagnostic value of label-free CTC enrichment combined with HER2 quantification. Further studies in larger cohorts should be conducted to validate our findings and investigate the clinical relevance of HER2-positive CTCs detected with the developed pipeline, particularly in the context of anti-HER2 therapies.

Our study shows that CTCs provide key information that would have been missed by ctDNA monitoring alone and extends CTC and cfDNA genomic profiling to patients with a broad range of CTC counts for blood-based monitoring of HER2 status and other clinically actionable targets for informing treatment decisions in metastatic disease.

Simulations predict transitioning high-risk patients (CTC/tdEV score >1.75) to second-line FOLFIRI at week 4 or 10 improves median survival from 15.1 months (12.8-18.4 CI) to 22.7 months (17.1-35.8 CI), and from 13.3 months (10.5-21.7 CI) to 23.3 months (17.8-31.2 CI), respectively...These findings suggest that tdEVs, alone or in combination with CTCs, may help optimize treatment timing and outcomes in mCRC. The integration of CTCs and tdEVs into clinical practice could offer a personalized, cost-effective, and more sustainable alternative to routine imaging in managing advanced colorectal cancer.

Notably, the brightfield imaging strategy eliminates the need for fluorescence microscopy, enabling cost-effective and rapid CTC detection. Together, these results validate the platform's clinical applicability for low-abundance CTC detection and highlight its potential for real-world liquid biopsy-based cancer monitoring.