Discoveries in circulation.

CellSearch® IVD for MBC, MPC and MCRC

Intended 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® Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast or metastatic colorectal cancer. The test is to be used as an aid in the monitoring of patients with metastatic breast, prostate, or colorectal cancer. Serial testing for CTCs should be used in conjunction with other clinical methods for monitoring breast, prostate, and colorectal cancer. Evaluation of CTCs at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.

CellSearch® IVD for Metastatic Breast Cancer

A CTC count of 5 or more per 7.5 mL of blood at any time during the course of the disease is associated with a poor prognosis and is predictive of shorter progression free survival and overall survival.

Predict overall survival (OS)

Monitor therapy efficacy

A CTC count of 5 or more per 7.5ml of blood is predictive of shorter PFS and OS. The sensitivity, specificity and reproducibility of CellSearch® allows for more rapid observation of changes of CTCs as early as the first cycle of treatment to help evaluate patient progression earlier.

CellSearchâ„¢ IVD for Metastatic Colorectal Cancer

A CTC count of 3 or more per 7.5 mL of blood at any time during the course of the disease is associated with a poor prognosis and is predictive of shorter progression free survival and overall survival.

Description of Services

ApoCell is an authorized service provider for Veridex CellSearch® IVD. All tests are performed in our CLIA compliant facility by a certified scientist. Our experience, quality and completion time are unsurpassed.

• Automated sample handling and tracking
• Automated immunomagnetic enrichment using CellSearch System
• Enumeration of CTCs using CellTracks Analyzer II

Deliverables & Benefits

• 24 hr. processing from sample collection to custom report
• Interpretation of CTCs performed by a Veridex certified physician scientist
• Custom report detailing cell counts
• CTC image acquisition on file