Intended Use and Limitations

For in vitro diagnostic use.

The CELLSEARCH® Circulation 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 CTC 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 metastatic breast, colorectal, and prostate cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.

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 were defined as having two 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. For more information on the intended use and limitations for the CELLSEARCH® Circulating Tumor Cell Test, please refer to the Instructions for Use which can be found at documents.cellsearchctc.com.