The Breast Cancer challenge

Breast cancer represents one of the most complex and heterogeneous malignancies, demanding sophisticated laboratory testing approaches. Diverse molecular subtypes require tailored treatment strategies, from hormone receptor-positive to HER2-positive and triple-negative breast cancers, as such, finding the right laboratory partner becomes critical to success. 

The complexity of breast cancer biomarker testing, including ER, PR, HER2 status determination, Ki-67 proliferation markers, and emerging targets like PIK3CA mutations, requires a collaborator with deep expertise in immunohistochemistry, next-generation sequencing, and advanced analytical techniques. 

Our specialists support the full spectrum of breast cancer studies from discovery through phase III registration trials, providing the specialized testing capabilities and regulatory expertise.

Here’s an overview of the unique solid tumour offerings at Cerba Research:

Unique offerings for your Breast Cancer trial

DNA / RNA

NGS, oncopanels, broad panels,
custom panels
RNA seq,
Single-gene
CDNA-based panels
ddPCR. qPCR
Whole exome / whole genome
HLA typing
TCR / BCR seq
NanoString®
SNP-array
DNA/RNA extraction
Streck Cell-Free DNA BCT®
PaxGene®, Qiamp, kits

Routine/Safety

Coagulation
Hematology
Biochemistry
Urinalysis
Pregnancy test
COVID test
Serology
Thyroid function
HbA1c
Protein electrophoresis (sPEP.
UPER SELC)
Tumor markers
Drug screens

Antibodies,,Immunoglobulin,Ig,Proteins,3d,Medical,Background.,Immune,System,,Igm,
Protein

Large portfolio of ligand binding
assays
ELISA
ELLA
ECLIA
MSD
ELISpot
FluroSpot
PK/ADA/Nab
Multiplex cytokine profiling (37-plex)

Cell

Flow Cytometry
Cytek Aurora Immunophenotyping (including intra-cell markers)
Receptor occupancy
MRD detection (for MM by EuroFlow)
CAR T cell enumeration
CAR T cell phenotyping
Intracellular cytokine detection
PBMC isolation
BMMC isolation
Optical genome mapping, our next-generation cytogenetics
PK/ADA/Nab

Tissue

Multiplex / simplex IHC
250+ biomarkers/protocols
Full histopath service Halo®, Visiopharm®
Al in image analysis
Board certified pathologists
Large biobank
Strong immuno-oncology simplex &
multiplex panels
Spatial analysis of the tumor
microenvironment
NanoString® GeoMx, FISH,

We recommend starting engagement with our scientific team early, such as at the protocol design phase, for optimal results. We’re ready to discuss your needs.

Case Study: Phase I Study with an Anti-TIGIT mAb in Solid Tumors

Strong histopathology capabilities

Biomarkers in Breast Cancer

Biomarker assay development is essential for breast cancer research success, with precise detection of ER, PR, HER2, and emerging markers like PIK3CA requiring validated, customized laboratory solutions that can be deployed globally across clinical development phases.

Here’s how our testing capabilities support your breast cancer trials:

Cerba Research supports Breast Cancer biomarker guidelines

Breast Cancer Biomarkers Most Commonly Deployed(1-4) Cerba Research NGS Cerba Research IHC Cerba Research FISH
HER2 IHC
ER IHC
PR IHC
PD-L1 IHC (22C3 Ab) ✔ (clones, 22C3, SP142, SP263, multiplexed)
Ki67 IHC
PKI3CA NGS, PCR, liquid biopsy
NTRK fusions NGS, FISH, PCR
TMB-H NGS
MSI-H/dMMR NGS, IHC, PCR
BRCA1/ BRCA2 Germline sequencing
RET fusions NGS
ESR1 NGS, PCR

We have ~160 targets/protocols/clones (clones and validation status available upon request)

ABCC4 CD22 Collagen I HER-2 LAG-3 Pan-TRK TCRgd
Adipophilin CD25 Collagen III HIS Lambda PD-1 TIM-3
ALK CD3 Collagen VII HLA-DR LIF PD-L1 Tissue Factor
ALPP CD30 Connexin 43 HPGD MASH1 PHH3 TNFa
AMH CD31 CTLA-4 HulgG MEK-1 PMS2 TNFR2
aSMA CD38 CXCL12 IDO MLH-1 PR TNFRSF14
BRAF V600E CD39 DLL3 IFNγ MSH2 PTK7/CCK4 TROP2
BrdU CD4 E-Cadherin IL-10 MSH6 RET Vimentin
CAIX CD44 EGFR IL-13 Muc5ac ROR1 VRK1
CC-10 CD45 Elastin IL-7 Muc5b ROS1 XBP-1s
CCR8 CD45RO EP4R IL-1a NCR1/NKp46 SCN5A YAP
CD11B CD47 EpCAM IL-1b Nectin-1 SIRPa
CD123 CD52 ER IL-1RAP Nectin-4 SKN1
CD138 CD56 FAP IL-22 Neutrophil Elastase SLCO2A1/PGT
CD155 CD68 FGFR3 IL-23 OX40 SLFN11
CD16 CD8 FoxA3 IL-33 OX40L SPDEF
CD163 CD99 FoxP3 IL-34 p16 Taz
CD163 CK16 GM-CSF INSM1 p53 TCF4
CD19 Cleaved Caspase 3 Granzyme B Kappa Pan-Keratin TCL1
CD20 cMet H. Pylori Ki-67 Pan-TEAD TCR Vy9

*Validation levels of biomarkers will vary dependina on intended use: This list is not exhaustive – contact us for further information on a specific biomarker or panel; Updated 13May2025 from the CRM test menu

We have ~30 panels (clones and validation status available upon request)

Adipopphilin/CD138/CD45 CD20/XBP1s mPGES-1/PTGES
BCMA/CXCR3/CD20/CD138/CD3 CD68/CD163 NKp46/CD8/Granzyme B/TCRyõ
CCR8/TNFR2 CD68/CD163/PD-L1/EP4R/PanCK PanCK [AE1/AE3)
CD3/CD8/FoxP3 CD68/PD-L1/PanCK Panel M1/M2 (PSTAT1/cMAF/CD68/CD163)
CD3/CD8/FoxP3/EP4R/PanCK CK8/CK18 TCF4/CD123
CD3/CD11b/CD47/SIRPa Elastin/Vimentin
CD3 /CD16/CD56 EP4R/Cox2/mPGES-1/PanCK
CD3/FoxP3 Ki-67/Granzyme B/CD8
CD4/GATA-3/CD3/FoxP3 Langerin/CD1a
CD8/CD39 MCP-1/CCL2

*Validation levels of biomarkers will vary dependina on intended use: This list is not exhaustive – contact us for further information on a specific biomarker or panel, Updated 13May2025 from the CRM test menu

Our experience in the Breast Cancer landscape

DNA

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

We recommend starting engagement with our scientific team early, such as at the protocol design phase, for optimal results. We’re ready to discuss your needs.