RarePlex® CTC Assays

RarePlex HER2/ER CTC Panel Kit
Breast Cancer Markers

Panel Kit for Breast Cancer Markers

Breast cancer research uses tumor markers, or serum markers produced by tumor cells, to identify the presence of breast cancer. Although most of these biomarkers can also be made by normal cells, they are produced at much higher levels in cancerous conditions. Breast cancer markers can be used to evaluate the patient's response to treatment or to detect the presence of metastasis or recurrence.

The CA 27-29, CA 15-3, carcinoembryonic antigen, and HER-2 are tumor markers that are often expressed in people with breast cancer. Three of these tumor markers — CA 15-3, CA 27.29, and CEA — have been used to help monitor metastatic breast cancer specifically.

The RarePlex HER2/ER CTC Panel Kit (assay code 0901-VB) provides highly accurate, repeatable, and precise results for CTC count and HER2 and ER biomarker expression, and is suitable for use in large, multi-center clinical trials of breast cancer.

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Benefits of the HER2/ER CTC Assay

  • Simple processing of blood to slides for sample banking
  • Convenient pause points in workflow enable sample control and transport from remote collection sites
  • Flexible sample handling — processing and analysis may be performed at the same site or at a separate clinical research laboratory
  • Extensive validation and a highly automated workflow yield accurate and highly reproducible results
  • Worldwide network of contract research organizations (CROs) to support global clinical trials

Clinical & Validation Data

Clinical breast cancer sample with HER2/ER Panel Kit

Clinical breast cancer samples stained with the HER2/ER CTC Panel Kit. Scale bar represents 10μm.

HER2 vs ER MFI scatter plot

HER2 versus ER MFI for individual clinical CTCs. Results reveal the heterogeneity of biomarker expression across multiple CTCs in the clinical setting. Mean fluorescence intensity thresholds for positivity are shown in the dashed copper lines and were defined by known model circulating tumor cells.

BT474 stained with HER2/ER CTC Panel Kit

BT474 cell line stained with the 0901-VB HER2/ER CTC Panel Kit. Scale bar represents 10μm.

Assay Design & Validation

RarePlex® CTC Assays: Design and Analytical Validation for Circulating Tumor Cells

Presented by Dr. Tad George, Sr. VP of Biology R&D. Gain insight into the principles RareCyte applies to its assay design and validation process.

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