ArgusCYTE Breast Health Test
The ArgusCyte test is highly sensitive, providing early warning about the presence of circulating breast cancer tumor cells (CTC) in a simple 'liquid biopsy' blood specimen. Finding CTCs before metastatic disease is clinically apparent affords early treatment options. The ArgusCYTE test unique provides gene expression data that informs the effectiveness of the most commonly used treatment options. Finding and evaluating circulating tumor cells helps inform effective breast health treatment and can help improve long term survival as demonstrated by numerous of clinical studies. ArgusCYTE can identify circulating cancer cells at the level of 2 cells/5 mL blood sample and can be used even immediately after a woman begins breast cancer therapy or at the time of diagnosis or biopsy so that she and her healthcare provider can make better informed decisions about effective treatment options. Used for recurrence monitoring and whenever there is a treatment decision to be made, the ArgusCyte test identifies mRNA expression levels for estrogen receptors (ER) progesterone receptors (PR), and HR-2 antigen to help guide treatment selection.
Overview
The ArgusCYTE test is currently available
Specimen
A blood sample collected in an ArgusCYTE specimen vial.
Clinical and Interpretive
Useful for: The ArgusCYTE Breast Health detects circulating tumor cells. The test can be used at the time of primary diagnosis to identify early systemic disease and to determine sensitivity for therapy. In the breast cancer survivor, the test can be used in conjunction with examination for local recurrence as part of an annual follow up visit. The serial changes in CTC number and ER/PR or Her-2 expression levels during therapy can provide early evidence of a favorable or unfavorable treatment effect.
Clinical Information: In patients with metastatic cancer, tumor cells may be present in the bloodstream (circulating tumor cells [CTCs]). Studies suggest that the number of CTCs is associated with progression-free and overall survival in patients with metastatic breast cancer.(1,2) Serial testing for CTCs, in conjunction with other clinical methods for monitoring breast cancer, can assist physicians in the management of these patients.(3)
Reference Values: An interpretive report will be provided
Interpretation: Results are reported as positive for CTCs or not detected.
Cautions
This test is not FDA approved but has been developed as a Laboratory Developed Test.
Patients on doxorubicin (Adriamycin) must wait a minimum of 7 days after administration before blood is drawn for this test.
Blood specimens must be drawn in a ArgusCYTE tube and received in the laboratory for processing within 24 hours of the blood draw.
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. Allard WJ, Matera J, Miller MC, et al: Tumor cells circulate in the peripheral blood of all major carcinomas but not in healthy subjects or patients with nonmalignant diseases. Clin Cancer Res 2004 Oct 15;10:6897-6904
3. Cristofanilli M, Hayes DF, Budd GT, et al: Circulating tumor cells: a novel prognostic factor for newly diagnosed metastatic breast cancer. J Clin Oncol 2006 Mar 1;23:1420-1430
Performance
Method Description: Circulating tumor cells (CTCs) are immuno-magnetically isolated from whole blood. Messenger RNA (mRNA) from these cells is harvested and reversed transcribed. Multiplex PCR is carried out to interrogate several key breast cancer and CTC related markers. The multiplex PCR product is analyzed by capillary electrophoresis.
Day(s) and Time(s) Test Performed: Monday through Friday, 0800-1700 PT
Day(s) and Time(s) Blood Draws Should Occur: Monday through Thursday, shipped, as provided, overnight
Analytic Time: 2 days
Maximum Laboratory Time: 7-10 business days
Specimen Retention Time: cDNA and DNA is retained according to Federal CLIA and Washington MTS regulations.
Performing Laboratory Location: National Reference Laboratory for Breast Health, 1124 Columbia St, Suite 621, Seattle WA
Coding
Test Classification: This test was developed and its performance characteristics determined by the National Reference Laboratory for Breast Health in a manner consistent with CLIA requirements. The laboratory test has not been cleared or approved by the U.S. Food and Drug Administration.
CPT Code Information: Available upon request.