CellSearch^TM circulating tumor cell test

CellSearch

Test Synonym:

Circulating tumor cells, CTC

CPT Code:
88346 - (x3)
88361 - (x2)

88313

Turnaround Time:

4 days

Methodology:

Immunomagnetic selection and immunofluorescence

Specimen Requirements:

Two 10mL tubes (min 7.5mL each) whole blood in CellSave® preservative tube. (One tube 10mL min.)

Causes for Rejection:

Improper specimen labeling; insufficient sample volume; refrigerated, frozen or clotted specimen; specimen older than 96 hours

Specimen Stability:

15°-30° C for 96 hours

Storage and Handling:

Ship at ambient temperature. Do not refrigerate. Protect from extreme temperatures.

Reference Range:

>1 circulating tumor cell detected

Indication:

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. Cristofanilli M, et al. (2004) Circulating tumor cells, disease progression, and survival in metastatic breast cancer . N.Engl J Med 351: 781-791
2. Danila C, et al. (2007). Circulating tumor cell number and prognosis in progressive castration-resistant prostate cancer. Clin Cancer Res; 13 (23)
3. CellSearch Circulating Tumor Cell Kit Instructions for Use. Veridex, LLC, www.veridex.com