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CELLSEARCH®

Company:
Menarini
Type:
FDA Approved (PMA)
21d
Longitudinal Analysis of Manually and Automatically Classified Circulating Tumor Biomarkers and their Prediction of Survival in Metastatic Colorectal Cancer. (PubMed, Clin Pharmacol Ther)
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.
Journal
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CELLSEARCH®
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5-fluorouracil • irinotecan • leucovorin calcium
21d
A Covalent Click Chemistry Chip for Highly Efficient Capture and Brightfield Identification of Circulating Tumor Cells. (PubMed, Anal Chem)
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.
Journal • Circulating tumor cells
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EPCAM (Epithelial cell adhesion molecule)
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CELLSEARCH® • Parsortix Liquid Biopsy
1m
International expert consensus on the clinical integration of circulating tumor cells in solid tumors. (PubMed, Eur J Cancer)
This consensus offers practical guidance for clinical integration of CTCs and outlines strategic research priorities to unlock their full potential in precision oncology.
Journal • Circulating tumor cells
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AR (Androgen receptor)
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AR splice variant 7
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CELLSEARCH®
1m
Fast enrichment and detection of circulating tumor cells from large volumes of whole blood of breast cancer patients utilizing a functionalized bioaffinity CTC filtration membrane. (PubMed, Int J Cancer)
Importantly, we also demonstrated the feasibility of processing blood samples of up to 40 mL or 2 × 108 nucleated blood cells in 2.5 min. Overall, our new system provides the advantage of performing ultra-rapid enrichment of CTCs and upscaling the volume of blood that can be analyzed, which opens a new avenue for studies on CTC biology.
Journal • Circulating tumor cells
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CELLSEARCH®
1m
Circulating tumour cells are a prognostic indicator in advanced high-grade serous ovarian cancer and are associated with platelets and immune cells following dissemination. (PubMed, Br J Cancer)
Peripheral CTCs isolated from patients with HGSC were predictors of a poor prognosis. The ovarian vein was found to be a rich source of disseminating CTC clusters in HGSC. Further studies are warranted to investigate the utility of CTCs as markers of neoadjuvant chemotherapy response as well as for longitudinal monitoring. Molecular analysis of CTCs in HGSCs reveals a potential role of the immune system in CTC-mediated haematogenous metastasis.
Journal • Circulating tumor cells
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CD73 (5'-Nucleotidase Ecto) • EPCAM (Epithelial cell adhesion molecule)
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CELLSEARCH® • Parsortix Liquid Biopsy
2ms
Prognostic significance and predictive value of circulating tumor cells in invasive lobular breast carcinoma - an exploratory analysis of the STIC CTC trial. (PubMed, Clin Cancer Res)
ILC shed more CTCs than NST, likely due to biological differences. While the ≥5 CTC/7.5mL threshold remained a valid prognostic marker for both, it was predictive of chemotherapy benefit in NST, but not ILC. These findings highlight differences in biomarker utility between ILC and NST, affecting both threshold relevance and treatment response.
Journal • Circulating tumor cells
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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CELLSEARCH®
2ms
CTC-EXPRESS: A Study for CTC Expression and cfDNA/RNA Assessment in Metastatic Breast Cancer Patients (clinicaltrials.gov)
P=N/A, N=187, Not yet recruiting, Menarini Silicon Biosystems, INC | Initiation date: Jul 2025 --> Oct 2025 | Trial primary completion date: Jul 2027 --> Oct 2027
Trial initiation date • Trial primary completion date • IO biomarker
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PD-L1 (Programmed death ligand 1)
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CELLSEARCH®
3ms
The ACCEPTance of automation: refining circulating tumor cells enumeration for improved metastatic colorectal cancer prognosis. (PubMed, Mol Oncol)
However, CHC enumeration showed no significant association with clinical outcomes, suggesting sporadic detection rather than consistent prognostic value. These findings underscore the reliability of automated CTC enumeration in mCRC prognosis while highlighting the need for further research into the biological and clinical roles of CHC.
Journal • Circulating tumor cells
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CELLSEARCH®
3ms
Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC (clinicaltrials.gov)
P1/2, N=50, Active, not recruiting, Weill Medical College of Cornell University | Trial completion date: Dec 2025 --> Aug 2026
Trial completion date
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CELLSEARCH®
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Pluvicto (lutetium Lu 177 vipivotide tetraxetan)
3ms
Re-treatment 225Ac-J591 for mCRPC (clinicaltrials.gov)
P1, N=6, Completed, Weill Medical College of Cornell University | Active, not recruiting --> Completed
Trial completion
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CELLSEARCH®
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Ac-225 rosopatamab tetraxetan (CONV01-α)
3ms
Circulating tumor cells dynamics after CDK4/6 inhibitor for hormone-receptor positive metastatic breast cancer: a biomarker analysis from the PACE phase II study. (PubMed, Clin Cancer Res)
Baseline CTC enumeration provides significant prognostic information in HR+/HER2- MBC. StageIV aggressive patients derive greater benefit from F+P or F+P+A over F alone, independent of clinical or ctDNA features. This highlights the potential of to guide treatment decision-making.
P2 data • Journal • Circulating tumor cells • PD(L)-1 Biomarker
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HER-2 (Human epidermal growth factor receptor 2)
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HR positive • HER-2 negative • HR positive + HER-2 negative
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Guardant360® CDx • CELLSEARCH®
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Ibrance (palbociclib) • Bavencio (avelumab) • fulvestrant
4ms
Circulating tumour cells & circulating tumour DNA in patients with resectable colorectal liver metastases (MIRACLE): a prospective, observational biomarker study. (PubMed, EClinicalMedicine)
Postoperative ctDNA and CTC detection both represent strong, independent predictors for a shorter RFS after local treatment, as opposed to preoperative detection. This work was supported by KWF Kankerbestrijding (Dutch Cancer Society, EMCR 2014-6340).
Observational data • Journal • Circulating tumor cells • Circulating tumor DNA
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CELLSEARCH®