An FDA-cleared CTC test for metastatic breast cancer, metastatic prostate cancer and metastatic colorectal cancer

The CELLSEARCH® CTC Test can help you make more informed patient-care decisions1-3 Learn More

Expanding Tabs: 
> Intended Use and Limitations

For in vitro diagnostic use.

The CELLSEARCH® Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood.

The presence of CTCs in the peripheral blood, as detected by the CELLSEARCH® CTC Test, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast, colorectal, or prostate* cancer. The test is to be used as an aid in the monitoring of patients with metastatic breast, colorectal, or prostate cancer. Serial CTC testing should be used in conjunction with other clinical methods for monitoring

CELLSEARCH® CTC Test results should be used in conjunction with all clinical information derived from diagnostic tests (eg, imaging, laboratory tests), physical examination, and complete medical history, in accordance with appropriate management procedures.

*Metastatic prostate cancer patients in this study were defined as having 2 consecutive increases in the serum marker prostate-specific antigen above a reference level, despite standard hormonal management. These patients are commonly described as having androgen-independent, hormone-resistant, or castration-resistant prostate cancer.

  1. Cristofanilli M, Hayes DF, Budd GT, et al. J Clin Oncol. 2005;23(7):1420-1430.
  2. de Bono JS, Scher HI, Montgomery RB, et al. Clin Cancer Res. 2008;14(19):6302-6309.
  3. Cohen SJ, Punt CJA, Iannotti N, et al. J Clin Onco. 2008;26(19):3213-3221