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CellsWay CTC Test
Capture and analysis of circulating tumor cells (CTC) with a simple blood test — for cancer monitoring
Rx-only — prescription screening test. Galleri® is not a diagnostic test. A positive result does not mean a cancer diagnosis; a negative result does not rule out cancer. The test does not replace the routine cancer screenings recommended by your physician. Galleri® does not detect all cancers.
CTC liquid biopsy is a method that captures and analyzes circulating tumor cells (CTC) from the blood of cancer patients. Performed with CellsWay's microfluidic technology, the test enables close monitoring of the disease and treatment, with real-time information through serial measurements. The panels are for research use only (RUO).
Cancer cells that break off from the tumor mass and enter the bloodstream are called "circulating tumor cells" (CTC). While most are destroyed by the immune system, some surviving CTCs reach a new organ through the blood, proliferate and cause the metastases responsible for over 90% of cancer deaths.
CTC liquid biopsy captures and analyzes these cells from blood. Traditional tissue biopsy requires removing tumor tissue, while CTC liquid biopsy requires only a single tube of blood — risk-free, painless, and applicable in series for real-time information.
Technology
The CellsWay CTC analysis instrument captures and analyzes tumor cells from the blood of cancer patients with its proprietary microfluidic technology. Analytical performance studies in lung, breast, prostate, colorectal and ovarian cancers have shown that CTCs can be captured with high efficiency. The analysis is applicable across all stages and for relapse monitoring.
Test Panels
CTC Identification Panel — detects epithelial circulating tumor cells (CD45⁻, cytokeratin⁺, DAPI⁺) by immunofluorescence analysis; contains all solutions for cytokeratin, CD45 and nucleus staining.
ER/PR/Her2 CTC Panel — determines hormone receptors (ER, PR) and HER2 status on CTCs by immunofluorescence. These markers play an important role especially in breast cancer course and treatment management; used together with the CTC identification kit.
PD-L1 CTC Panel — determines the PD-L1 biomarker on CTCs by immunofluorescence. PD-L1 positive patients have been reported to respond better to immune checkpoint inhibitor drugs; it plays an important role especially in lung cancer course and treatment management.
Evidence
In clinical studies, CTC positivity of 90% in prostate cancer and 60% in breast cancer was detected. An ongoing 300-patient clinical study targets workflow optimization in newly diagnosed Stage III/IV patients. The strategic partnership between Omega Genetik and CellsWay was signed in 2023.
Note: the instrument, microfluidic chip and test panels are for research use only (RUO); they are not used to guide cancer diagnosis or treatment.
Key Features
Just one tube of blood — risk-free, painless
Real-time monitoring through serial measurement
High-efficiency CTC capture with microfluidic technology
CTC Identification + ER/PR/Her2 + PD-L1 panels
Applicable to patients who cannot undergo tissue biopsy
Applicable across all stages and for relapse monitoring
Who Is This Test For?
Eligibility is determined by physician evaluation; the lists below are general guidance.
May Be Suitable
- All cancer patients who can give blood from a vein
- Patients under treatment — disease and treatment monitoring
- Breast cancer patients — ER/PR/Her2 profile follow-up
- Patients under relapse monitoring
Not Suitable
- Not applied to patients with hematological cancers
- Not used for cancer screening in healthy individuals — Galleri® is considered for screening
- The panels are for research use only (RUO); not used to guide diagnosis or treatment
How Does the Process Work?
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1
Information Request
Fill in the form; your physician's request is evaluated and we share the process and pricing.
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2
Blood Draw
A single tube of blood is drawn from the vein — at home with our nurse service or at our laboratory.
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3
Separation and Identification
Cancer cells are separated from blood cells and identified; advanced molecular analyses are performed when needed.
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4
Report
The pathology report is prepared and delivered to your physician within approximately 2 weeks.
Sample Type
One tube of blood from the vein
Turnaround Time
Results are delivered to your physician within approximately 2 weeks
Get information about Galleri®
Capture and analysis of circulating tumor cells (CTC) with a simple blood test — for cancer monitoring