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

Curious what oncologists across the US have to say about the clinical utility of DefineMBC?

A recent paper authored by Drs. Schwartzberg and Kaklamani summarizes key findings.

Download The Paper Now

As an oncologist you strive to provide the best patient care, yet challenges along the diagnostic journey may lead to incomplete care planning

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

Cellular analysis of ER and HER2 from tissue biopsy is not always attainable1,2

Metastatic breast cancer evolves over time to evade targeted therapy3,4

Tissue biopsies may not fully account for tumor heterogenity2,3

Other liquid biopsies provide up-to-date information on genomic alterations, but don't evaluate cells2

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

Cellular analysis of ER and HER2 from tissue biopsy is not always attainable1,2

Metastatic breast cancer evolves over time to evade targeted therapy3,4

Tissue biopsies may not fully account for tumor heterogenity2,3

Other liquid biopsies provide up-to-date information on genomic alterations, but don't evaluate cells2

Obtaining serial tissue biopsies is not always practical

You can be confident in the well-validated and comprehensive results of DefineMBC when making care plans

DefineMBC Analytical Validation⁵

Assay

Biomarkers Assessed

Sensitivity

Specificity

CTC Protein Expression

ER & HER2

91% & 94%

100% & 97%

Single-Cell Genomic Analysis

ERBB2 amplification

85-100%*

94%

ctDNA Genomic Alterations

56 genes

98.2-100%*

99.9-100%*

* Tested using the MDA-MB-453 (low positive [~2-fold]) and SK-BR-3 (high positive [~10-fold]) cell lines
† Includes SNVs, CNAs, small indels and fusions

View Additional Data

DefineMBC evaluates key biomarkers to help establish comprehensive care plans for patients with metastatic breast cancer

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

Cell-based analysis of ER and HER2 protein expression
Single-Cell Genomic Analysis for ERBB2 amplification and genomic instability
ctDNA evaluation of MSI, TMB , and genomic alterations in 56 relevant genes

Analysis of all nucleated cells for markers consistent with cancer

Detection of ER and HER2 protein expression from CTCs using immunofluorescence

Detection of ERBB2 gene amplification from CTCs using single-cell genomic analysis

Summary of genomic alterations detected from ctDNA analysis. Additional clinical evidence, targeted therapies, and clinical
trials on genomic alterations identified can be found on later pages of the report

TMB and MSI analyses to help identify candidates for immunotherapy

Summary and interpretation of CTC and ctDNA analyses related to HER2

Comments from the Lab Director with additional information about findings from DefineMBC

Which patients can benefit from DefineMBC?

Metastatic diagnostic biopsy unsuccessful

No 1L Diagnostic Biopsy

Patient with metastatic breast cancer and now metastatic biopsy to guide 1L treatment

Outdated Biomarkers

Patient in 2L+ setting, but care plan based upon original early-stage breast cancer diagnosis

Metastatic diagnostic biopsy successful

Abnormal Progression

Patient progressed faster than expected based on subtype

Expected Progression

Patient progressed in the expected amount of time based on subtype

DefineMBC can help identify patients with metastatic breast cancer cells that are consistent with a HER2-low classification

More than half of metastatic breast cancers classified as HER2-negative express low levels of HER2 protein.6 This low level of expression, in the absence of gene amplification, was shown to be clinically relevant in the DESTINY-Breast04 clinical trial.7 In this study, patients with HER2-low metastatic breast cancer had significantly longer progression-free survival when treated with trastuzumab deruxtecan instead of traditional chemotherapy. While traditional pathology methods such as IHC and ISH remain the gold standard for biomarker classification, these methods require a tissue sample, which is not always available or feasible to obtain in patients with metastatic disease. DefineMBC analyzes HER2 protein expression and ERBB2 gene amplification from a minimally invasive blood draw to help identify cancers consistent with a HER2-low classification. DefineMBC has identified patients with HER2 expression on CTC analysis but no ERBB2 amplification in either CTC or ctDNA analysis. Interested in using DefineMBC for your patients with metastatic breast cancer? Fill out the form below to learn more.

HER2-Low

Determining HER2-low status requires evaluation of two components: protein for HER2 expression and DNA for ERBB2 gene amplification. Tissue testing evaluates protein expression by IHC and gene amplification by ISH. DefineMBC identifies HER2 protein expression using immunofluorescence on CTCs and assesses ERBB2 gene amplification using NGS on both CTCs and ctDNA.

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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 5. Data on File. Epic Sciences. 6. Tarantino P, Hamilton E, Tolaney SM, et al. HER2-low breast cancer: pathological and clinical landscape. J Clin Oncol. 2020;38(17):1951-1962. doi: 10.1200/JCO.19.02488. 7. Modi S, Jacot W, Yamashita T, et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387:9-10. DOI: 10.1056/NEJMoa2203690