Practice and clinical validation
The application of the GILUPI CellCollector® is easy and resembles a venous blood withdrawal. The GILUPI CellCollector® is placed directly into the blood stream of a patient via an indwelling catheter (size 20 G, pink), remains in the arm vein for 30 min and thus enables the capture of CTCs in vivo.
CTCs can then be characterized, and molecular alterations of these cells, which mirror the remaining tumor tissue in the patient, can be detected by downstream diagnostics, such as immunofluorescence, Protein Analysis, qRT-PCR, FISH, Sequencing, Expression Analysis and Cell Culture. The analysis of applied GILUPI CellCollector® can be performed by established diagnostic laboratories or by the GILUPI lab.
Instructions for Use and application step by step
GILUPI CellCollector® – reimbursement of costs
For cancer patients who are hospitalized, the reimbursement of costs is regulated according to the respective German DRGs (German-Diagnosis Related Groups). For outpatients, the costs of CTC detection could/would be partially covered by private health insurances. There is also the opportunity to use the GILUPI CellCollector® following non-contractual or IGel (special services German Health system) liquidation terms.
Clinical validation of the GILUPI CellCollector® method
The GILUPI CellCollector’s biocompatibility, functionality and safety have been proven in clinical trials that included cancer patients as well as healthy subjects. The product has been shown to be well tolerated.
The clinical validation was performed in comparison to an approved standard method (which is based on the analysis of small sample volumes) and has demonstrated that the GILUPI CellCollector® is able to isolate significantly higher numbers of CTCs in early stages.
CTCs were detected in 70% of the GILUPI CellCollector® applications in lung, breast, colorectal and prostate cancer patients. Further studies with other indications, such as kidney cancer, head and neck cancer and neuroendocrine tumors are currently in process.
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