Molecular Pathology Laboratory Network

CellSearch™ - Circulating Tumor Cell Test Featured

Test Code
CELLSEARCH
Test Synonyms
Circulating tumor cells, CTC
Associations
Metastatic breast, colorectal and prostate cancer
Methodology
Immunomagnetic selection and immunofluorescence
CPT Codes
88346 x4 - Immunofluorescent study, each antibody
88361 x2 - Using computer-assisted technology
Turnaround Time
4 days
Specimen Requirements
Two 10.0 mL tubes (min. 7.5 mL each) whole blood in CellSave® preservative tube (One tube 10 mL min.)
Specimen Stability
CellSave tubes stable at 15-30° C for 96 hours
Storage & Handling
Ship at ambient temperature. Do not refrigerate. Protect from extreme temperatures
Causes for Rejection
Improper specimen labeling; Insufficient sample volume; refrigerated; Frozen or clotted specimen; Specimen older than 96 hours
Reference Range
>1 circulating tumor cell detected
Action threshold is >5 circulating tumor cells
Description
The FDA-approved Veridex, LLC CellSearch Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelia origin in peripheral blood samples. The assay predicts progression-free survival (PFS) and overall survival (OS) in patients treated for metastatic breast, colon and prostate cancer. A CTC count of 5 cells / 7.5mL blood or greater as determined by the assay is predictive of shorter PFS and OS for patients with metastatic breast and/or prostate cancer. A CTC count of 3 cells / 7.5mL blood or greater is predictive of shorter PFS and OS for patients with metastatic colon cancer.
References
  1. Cohen et al. (2008). Relationship of circulating tumor cells to tumor response, rrogression-free survival, and overall survival in Patients with metastatic colorectal cancer. J Clin Oncol. Jul 1;26(19):3213-21.
  2. Danila C et al. (2007). Circulating tumor cell number and prognosis in progressive castration-resistant prostate cancer. Clin Cancer Res. 13(23).
  3. Budd et al. (2006). Circulating tumor cells versus imaging – predicting overall survival in metastatic breast cancer. Clin Cancer Res. 12(21).
  4. Cristofanilli M et al. (2004). Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N. Engl J Med. 351:781-791.
Trademarks
CellSearch is a trademark of Johnson & Johnson.

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