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No cell left behind.
No information left behind.
No patient left behind.

Analysis of ER and HER2 protein expression are fundamental to care planning for patients with metastatic breast cancer

Challenges along the diagnostic journey may lead to incomplete care planning

Metastatic breast cancer changes over time and serial tissue biopsy is considered impractical and not sufficiently informative. As a result, comprehensive, up-to-date information is often not available to guide care plans.1-4

DefineMBC is the most comprehensive liquid biopsy option for patients with metastatic breast cancer

DefineMBC combines analyses of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) to provide up-to-date information on ER and HER2 protein expression and genomic alterations that may guide care planning

DefineMBC analyzes a minimally invasive blood sample and provides a comprehensive clinical report that includes:

  • Cell-based ER and HER2 protein expression
  • Single-Cell Genomic Analysis for ERBB2 amplification and genomic instability
  • ctDNA evaluation of MSI, TMB, and relevant genomic alterations in 56 genes
DefineMBC Analytical Validation
Assay
Biomarkers Assessed
Sensitivity
Specificity
CTC Protein Expression

ER & HER2

91-94%
99.7-100%
Single-Cell Genomic Analysis

Genomic instability & ERBB2 amplification

85%
95%
ctDNA Genomic Alterations

56 genes

98.2-100%*
97.9-99.9%*
* includes SNV, CNV, Fusions.
Intended Use: DefineMBC is a test designed for use on breast cancer patients when metastatic disease is suspected or has previously been confirmed and for whom surgical tissue biopsy is not feasible, or when the results of surgical biopsy are indeterminate or inadequate including when there is insufficient tissue sample to process.

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References

1. Van Poznak C, Somerfield MR, Bast RC, et al. Use of biomarkers to guide decisions on systemic therapy for women with metastatic breast cancer: American Society of Clinical Oncology Clinical Practice Guidelines. J Clin Oncol. Published July 20, 2015. 2015;33(24):2695-2704.doi:10.1200/JCO.2015.61.1459 2. Alba-Bernal A, Lavado-Valenzuela R, Domínguez-Recio ME, et al. Challenges and achievements of liquid biopsy technologies employed in early breast cancer. EBioMedicine. 2020;62:103100. doi:10.1016/j. ebiom.2020.103100 3. Tay TKY, Tan PH. Liquid biopsy in breast cancer. Arch Pathol Lab Med.2021;145(6):678-686. doi:10.5858/arpa.2019-0559-RA 4. Schrijver WAME, Suijkerbuijk KPM, van Gils CH, et al. Receptor conversion in distant breast cancer metastases: a systematic review and meta-analysis. J Natl Cancer Inst. 2018;110(6):568-580. doi:10.1093/jnci/djx273