The immuno-oncology opportunity

Immuno-oncology represents one of the most transformative therapeutic opportunities in cancer treatment, harnessing the power of the immune system to fight malignancies across multiple tumor types. However, this revolutionary approach brings unique challenges that demand tailored, specialized laboratory expertise and sophisticated biomarker testing strategies.

The complexity of immune checkpoint pathways, tumor microenvironment interactions, and patient-specific immune responses requires comprehensive testing for PD-L1 expression, tumor mutational burden (TMB), microsatellite instability (MSI), and mismatch repair deficiency (dMMR) status. Each are critical for predicting treatment response and optimizing patient selection.

Finding the right laboratory partner becomes essential for navigating the intricate landscape of immuno-oncology biomarker detection, where precision in PD-L1 scoring, advanced sequencing capabilities, and expertise in immune profiling can determine the success or failure of groundbreaking therapies.

Our specialists support the full spectrum of immuno-oncology studies from discovery through phase III registration trials, providing the advanced testing capabilities and regulatory expertise necessary for unlocking the therapeutic potential of immunotherapy.

Unique offerings for your Immuno-oncology trial

DNA / RNA

NGS, oncopanels,
broad panels, custom panels
RNA seq
Single-gene
ctDNA-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, uPEP, sFLC)
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
PK/ADA/Nab
Multiplex cytokine profiling (37-plex)

Cell

FCM
Spectral flow (Cytek Aurora)
Immunophenotyping (including intra-cell markers)
Receptor occupancy
MRD detection
(for MM only)
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®,
AI experiments
Board certified pathologists
Large biobank
Strong immuno-oncology simplex & multiplex panels
Spatial analysis of the tumor microenvironment
NanoString®, GeoMx, FISH, ISH

Cerba Research data in-house; NGS=next-generation sequencing; ctDNA=circulating tumor DNA; HLA=human leucocyte antigen; TCR=T cell receptor; MSD=mesoscale discovery; Flow Cytometry,  PBMC=peripheral blood mononuclear cell; BMMC=bone marrow mononuclear cell; PK/ADA/Nab=pharmacokinetic/antibody-drug antibody/neutralizing antibody; IHC=immunohistochemistry; FISH=fluorescence in situ hybridization; ISH=in situ hybridization

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.

Biomarkers in Immuno-oncology

Biomarker assay development is essential for immuno-oncology research success, with precise detection of PD-L1, tumor mutational burden (TMB), microsatellite instability (MSI), and mismatch repair deficiency (dMMR) requiring validated, customized laboratory solutions that can be deployed globally across clinical development phases. 

The dynamic nature of immune responses and the heterogeneity of tumor microenvironments present unique testing challenges that demand expertise across multiple platforms, from advanced immunohistochemistry for PD-L1 scoring with validated clones (22C3, SP142, SP263) to next-generation sequencing for TMB assessment and molecular testing for MSI-H/dMMR status. 

Understanding which biomarkers to test, when to test them, and how to interpret results within the context of specific tumor types becomes crucial for immuno-oncology success, requiring laboratory partners with deep expertise in immune profiling and regulatory compliance.

Here’s how our testing capabilities support your immuno-oncology trials:

CRC​ Biomarkers Most Commonly Deployed(1-2) Cerba Research NGS*​ Cerba Research​ IHC*​ Cerba Research FISH†​
KRAS​ NGS MEK1​
NRAS​ NGS
BRAF​ NGS​
HER2​ IHC, FISH​ ✔​
NTRK​ IHC, FISH, NGS​
RET​ IHC, FISH, NGS​
CEA​ IHC​
TMB​ PCR, NGS​
MSI​ PCR, NGS​ ✔​
MMR​ IHC​

1.NCCN guidelines 2024; 2.Bebb et al. Curr Oncol 2021; *Cerba Research Data In-house mostly available through the ACTOnco®/Cerba France/Cerba US NGS panels or CR Montpellier (IHC) or Cerba France (FISH); IHC=immunohistochemistry; NGS=next-generation sequencing; FISH=fluorescence in situ hybridization; CEA=carcinoembryonic antigen determination; TMB=tumor mutation burden; MSI=microsatellite instability; dMMR= mismatch repair deficient

This comprehensive biomarker landscape in immuno-oncology requires seamless integration of IHC, NGS, and specialized immune assays to provide the complete molecular and immunological picture needed for precision immunotherapy decisions across multiple cancer types.

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 depending on intended use; This list is not exhaustive – contact us for further information on a specific biomarker or panel; Updated 13 May 2025 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 depending on intended use: This list is not exhaustive – contact us for further information on a specific biomarker or panel, Updated 13 May 2025 from the CRM test menu

Our Experience in the Immuno-oncology landscape

~55%

Of our I/O trials are in solid tumors

~75%

Of I/O trials involve specialty testing

DNA

638

NGS broad-panel assay with our OncoSign 600+

250+

Histopathology analysis with markers such as PD-L1, dMMR, MSI-H run in CLIA accredited laboratories

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.