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Physicians

CellSearch® Assay for Detection of Circulating Metastatic Breast Cancer Cells

The CMM offers oncologists this FDA approved diagnostic assay for the analysis of circulating breast tumor cells (CTCs) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8+, 18+, and/or 19+) in whole blood. The test can identify as few as one cell in 7.5 mL of whole blood and is one of the most powerful new tools available to physicians treating metastatic breast cancer. Using a sophisticated and highly controlled system CTCs are isolated, visually identified and quantified for reporting by CMM medical technologists.

CellSearch test results may be used as a significant predictor of progression-free survival and overall survival in metastatic breast cancer patients. Several clinical studies have shown that that the assessment of CTCs can assist physicians in monitoring and predicting cancer progression, and evaluating response to therapy in patients with metastatic cancer.1,2

Results are reported as the actual number of CTCs present per 7.5 mL of blood, and trending of results is available through CMM for patient management. Patients can be tested at almost any point in their diagnosis or therapy timelines. Monitoring is best done by establishing a baseline circulating CTC value at diagnosis. Assessment of follow-up values four to five weeks after initiation of new therapy with periodic re-assessment thereafter ensures effective patient management.

The CMM is the only regional source for this test. Physicians are encouraged to contact the CMM directly to obtain more information as well as the mandatory CellSave blood draw tube and shipping materials. Patients are strongly encouraged to work with their physicians on the utility of this test in their healthcare management.

Specimen Requirements: 10 mL of whole blood drawn in a CellSave tube which should be obtained from CMM (616.391.4330). Blood must be shipped to CMM immediately via courier (within greater Grand Rapids) or FedEx shipping (packing materials and FedEx label available from CMM) for receipt within 48 hours of draw. Please avoid Thursday or Friday draws if possible so as to minimize the chances for bloods remaining unprocessed over a weekend.

The charge for the CellSearch Test is $495 and is covered by most major insurance carriers. Please contact CMM at 616.391.4330 or info@cmmdx.org for questions.

References

  1. Cristofanilli M, Budd GT, Ellis MJ, et al. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004;351:781-791.
  2. Cristofanilli M, Hayes DF, Budd GT, et al. Circulating tumor cells: A novel prognostic factor for newly diagnosed metastatic breast cancer. J Clin Oncol. 2005;23(7):1420-14.