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Breast Cancer

Cerba Research conducted many breast cancer trials in the past 5 years alone. The lab’s expertise extends to the utilization of clinically validated ER, PR, HER2 immunohistochemistry (IHC), alongside next-generation sequencing (NGS) broad-panel assays, circulation tumor DNA (ctDNA) panels, fluorescence in situ hybridization (FISH) and more. Get in touch to learn more.

What Is Breast Cancer?

Breast cancer is a disease in which atypical breast cells grow intensely to form tumors. Breast cancer starts inside the milk ducts and/or its lobules. The earliest stage is in situ (e.g. ductal carcinoma in situ (DCIS)), but if left unchecked, breast cancer can spread and become life-threatening (1). Breast cancer is complexified not only by its staging, but also by the presence of specific proteins / genes often detected with a tissue or liquid biopsy (e.g. estrogen receptors (ER), progesterone receptors (PR), HER2, and more) (2). ER, PR, and HER2 testing should also be performed using methodologies outlined in guidelines (3, 4, 5).

Cerba Research offers a wide range of histopathology and biomarker solutions that can be detected with cutting-edge techniques. Get in touch to learn more.

Breast Cancer Lesion

Cerba Research Breast Cancer Services

Our breast cancer specialists support the whole range of breast studies from discovery / preclinical (data not shown) to phase III registration trials and beyond. Most of our projects include specialty testing, such as, but not limited to, NGS broad-panel assays, ctDNA panels, 250+ IHC simplex and multiplex protocols, and fluorescence in situ hybridization (FISH).

ER Expression In Breast Cancer

Our Experience In The Breast Cancer Landscape

638

NGS broad-panel assay with our OncoSign 600+

50

Genes with OncoSign ctDNA panel

250+

Histopathology analysis with markers such as ER, PR, HER2 run in CLIA accredited laboratories

3

Techniques for HER2 IHC: HercepTest, HER2-NEU, HER2-CISH

Our Areas Of Expertise In Breast Cancer

Did you know that we can cover for your breast cancer biomarker needs? Check out our mapping exercise by select breast biomarkers against our Cerba Research offerings with three techniques (NGS, IHC, FISH) (3, 4). Interested in artificial intelligence (AI) image analysis for your breast cancer trial? Check out our resources here.

What Are Breast Cancer Guidelines Proposing? Aligned With Cerba Research Offerings

Breast Cancer Biomarkers Most Commonly Deployed Additional Assay(s) Cerba Research NGS† Cerba Research IHC† Cerba Research FISH†

HER2

IHC

ISH (reflex), FISH (reflex)

X

X

X

ER

IHC

X

PR

IHC

X

PD-L1

IHC (22C3 Ab)

X (clones, 22C3, SP142, SP263, multiplexed)

Ki67

IHC

X

PKI3CA

NGS, PCR, liquid biopsy

X

NTRK fusions

NGS, FISH, PCR

X

X

TMB-H

NGS

X

MSI-H/dMMR

NGS, IHC, PCR

X

X

BRCA1/ BRCA2

Germline sequencing

X

RET fusions

NGS

X

ESR1

NGS, PCR

ddPCR

X

Breast Cancer Biomarkers
Most Commonly Deployed

IHC

Additional Assay(s)

ISH (reflex), FISH (reflex)

Cerba Research NGS†

X

Cerba Research IHC†

X

Cerba Research FISH†

X

Breast Cancer Biomarkers
Most Commonly Deployed

IHC

Additional Assay(s)
Cerba Research NGS†
Cerba Research IHC†

X

Cerba Research FISH†
Breast Cancer Biomarkers
Most Commonly Deployed

IHC

Additional Assay(s)
Cerba Research NGS†
Cerba Research IHC†

X

Cerba Research FISH†
Breast Cancer Biomarkers
Most Commonly Deployed

IHC (22C3 Ab)

Additional Assay(s)
Cerba Research NGS†
Cerba Research IHC†

X (clones, 22C3, SP142, SP263, multiplexed)

Cerba Research FISH†
Breast Cancer Biomarkers
Most Commonly Deployed

IHC

Additional Assay(s)
Cerba Research NGS†
Cerba Research IHC†

X

Cerba Research FISH†
Breast Cancer Biomarkers
Most Commonly Deployed

NGS, PCR, liquid biopsy

Additional Assay(s)
Cerba Research NGS†

X

Cerba Research IHC†
Cerba Research FISH†
Breast Cancer Biomarkers
Most Commonly Deployed

NGS, FISH, PCR

Additional Assay(s)
Cerba Research NGS†

X

Cerba Research IHC†
Cerba Research FISH†

X

Breast Cancer Biomarkers
Most Commonly Deployed

NGS

Additional Assay(s)
Cerba Research NGS†

X

Cerba Research IHC†
Cerba Research FISH†
Breast Cancer Biomarkers
Most Commonly Deployed

NGS, IHC, PCR

Additional Assay(s)
Cerba Research NGS†

X

Cerba Research IHC†

X

Cerba Research FISH†
Breast Cancer Biomarkers
Most Commonly Deployed

Germline sequencing

Additional Assay(s)
Cerba Research NGS†

X

Cerba Research IHC†
Cerba Research FISH†
Breast Cancer Biomarkers
Most Commonly Deployed

NGS

Additional Assay(s)
Cerba Research NGS†

X

Cerba Research IHC†
Cerba Research FISH†
Breast Cancer Biomarkers
Most Commonly Deployed

NGS, PCR

Additional Assay(s)

ddPCR

Cerba Research NGS†

X

Cerba Research IHC†
Cerba Research FISH†

dMMR=mismatch repair deficient; ESR1=estrogen receptor 1; FISH=fluorescence in situ hybridization; IHC=immunohistochemistry; ISH=in situ hybridization; MSI-H=microsatellite instability-high; NGS=next-generation sequencing; PCR=polymerase chain reaction; TMB-H=tumor mutational burden-high

HER2 Expression In Breast Cancer

References

1. World Health Organization: Breast cancer. URL [Breast cancer (who.int)].

2. American Cancer Society®: What is breast cancer? URL [What Is Breast Cancer? | American Cancer Society].

3. Wolff AC, Hammond MEH, Allison KH, Harvey BE, Mangu PB, Bartlett JMS, Bilous M, Ellis IO, Fitzgibbons P, Hanna W, Jenkins RB, Press MF, Spears PA, Vance GH, Viale G, McShane LM, Dowsett M. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol. 2018 Jul 10;36(20):2105-2122. doi: 10.1200/JCO.2018.77.8738. Epub 2018 May 30. PMID: 29846122.

4. National Comprehensive Cancer Network®: NCCN guidelines, treatment by cancer type. URL [Treatment by Cancer Type (nccn.org)].

5. Allison KH, Hammond MEH, Dowsett M, McKernin SE, Carey LA, Fitzgibbons PL, Hayes DF, Lakhani SR, Chavez-MacGregor M, Perlmutter J, Perou CM, Regan MM, Rimm DL, Symmans WF, Torlakovic EE, Varella L, Viale G, Weisberg TF, McShane LM, Wolff AC. Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update. J Clin Oncol. 2020 Apr 20;38(12):1346-1366. doi: 10.1200/JCO.19.02309. Epub 2020 Jan 13. PMID: 31928404.

We recommend starting engagement with our scientific team early, such as at the protocol design phase, for optimal results. Reach out to us here.