CellSearch™ - Circulating Tumor Cell Test FeaturedTest 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
Trademarks CellSearch is a trademark of Johnson & Johnson. |
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