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Assay portfolio

 

 
  • OVERVIEW
  • NON-REGISTRATIONAL
  • REGISTRATIONAL

Assay portfolio

 

Our industry-leading on-market portfolio of high medical value IVD assays features the greatest number of companion diagnostics for targeted and immunotherapies, covering several indications and growing. We also offer an impressive menu of 75+ clinical trial ready assays supported in our CAP/CLIA lab, which includes many important emerging biomarkers as well as multiplex panels.

on-market assays

On-Market Assays

 

We help to advance Personalized Healthcare by delivering diagnostic confidence through a broad menu of high medical value assays. Our standardized, fully-automated and easy-to-use solutions enable rapid turnaround time, empowering physicians to make the right patient decisions more quickly.

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FEATURED BIOMARKER
 

MMR

 

Along with the development of promising new cancer medicines that target treatment of mismatch repair (MMR) deficient solid tumors has come significant scientific and clinical interest in MMR proteins as predictive biomarkers. An immunohistochemistry (IHC) predictive assay would potentially pave the way for treatment decisions to be made based on detection of deficiency for MMR proteins (MLH1, MSH2, MSH6 or PMS2) across many types of solid tumors. These proteins are currently used clinically to help differentiate between sporadic colorectal cancer and probable Lynch syndrome, a hereditary form of colorectal cancer.

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mmr

Assays customized to pharma’s needs

Robust prototype assay (RPA)
Robust prototype assay (RPA)
 

Allows biomarker hypothesis testing during early phase clinical studies with no immediate CDx development need. Offers flexibility for use in further research.

Formulation locked assay (FLA)
Formulation locked assay (FLA)
 

For biomarker hypothesis testing during early phase clinical studies with intent of transitioning to a CDx. Hybrid approach establishes assay feasibility and minimizes risk .

Investigational assay
Investigational assay
 

For biomarker validation testing to support registrational clinical studies and CDx health authority submissions.

Non-registrational assay menu

 

We offer a broad range of non-registrational assays supported in our CAP/CLIA lab, which includes many important emerging biomarkers as well as multiplex panels. Our capabilities are ever-evolving, so if you don’t see your biomarker of interest here, just ask.

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Biomarker
Technology
Multiplex

5T4

IHC

 

ADAM9

IHC

 

AFP

Immunoassay

 

ALK

ISH

 

AR

IHC

 

ATM

IHC

 

AXL

IHC

 

B7H3

IHC

 

Bcl-2

ISH

 

Bcl-xL

IHC

 

BCMA

IHC

 

BTKi Panel (IGJ, MZB1, TXNDC5)

PCR

 

C4.4a

IHC

 

CCR4

IHC

 

CD103

IHC

 

CD138

IHC

 

CD20

IHC

 

CD22

IHC

 

CD3

IHC

 

CD44

IHC

 

CD73

IHC

⚫

CD8

IHC

 

CDH6

IHC

 

CEA

IHC

 

Cyclin D1

IHC

 

CLDN6

IHC

 

DLL3

IHC

 

EGFR Mutation (exons 18, 19, 20, 21)

IHC

 

EREG

IHC

 

FAP

IHC

⚫

FGF19

IHC

 

FGFR1

IHC

 

FGFR1/Chr8

ISH

 

FGFR2/Chr10

ISH

 

FGFR2b

IHC

 

FGFR3

IHC

 

FOLR1

IHC

 

FOXP3

IHC

⚫

GDF-15

Immunoassay

 

GITR

IHC

 

Globo H

IHC

 

GPC3

IHC

 

HE4

Immunoassay

 

HER2

ISH

 

Heregulin

IHC

 

HPV16 E6/E7 mRNA

ISH

 

IDO1

IHC

 

Ki67

IHC

 

LAG3

IHC

⚫

LIF

IHC

 

LMO2

IHC

 

Mcl-1

IHC

 

MHCII

IHC

⚫

MSLN

IHC

 

MTAP

IHC

 

MUC16

IHC

 

MYC ISH

ISH

 

OX40

IHC

⚫

pERK

IHC

 

PIK3CA

ISH

 

PIVKAII

Immunoassay

 

ProGRP

Immunoassay

 

PSMA

IHC

 

PTEN

IHC

 

RAD51

IHC

⚫

Rb

IHC

 

RSK2

IHC

 

STEAP1

IHC

 

TIGIT

IHC

⚫

TIM3

IHC

⚫

Tissue Factor (TF)/CD142

IHC

 

TYRP1 DAB

IHC

 

TYRP1 Purple

IHC

 

YES1

ISH

 
technologies banner

Technologies

We offer a comprehensive breadth of technologies and solutions across tissue, molecular and sequencing, something no other company in the world can. Our integrated technology solutions and streamlined approach allows partners to choose from multiple methodologies to best support their diagnostic strategy.

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Registrational assay menu

 

We offer a broad range of investigation ready assays supported in our CAP/CLIA lab, which includes many important emerging biomarkers. Our capabilities are ever-evolving, so if you don’t see your biomarker of interest here, just ask.

View Full Table
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Biomarker
Technology
Multiplex
ALK IHC  
Bcl-2 IHC  
CD30  IHC  
CLDN18 IHC  
c-MET IHC  
c-Myc IHC  
EGFR PCR  
HA (Hyaluronic Acid) IHC  
HER2 IHC  
HER2 Dual ISH ISH  
HER3 IHC  
LIV-1 IHC  
MMR Panel IHC  
p16 IHC  
PD-L1 (SP142) IHC  
PD-L1 (SP263) IHC  
PTEN IHC  
TROP2 IHC  
registrational assays banner

Why Digital Pathology?

CDx assays are answering more complex questions than ever before. Our fully integrated uPath solution for digital pathology (DP) delivers new value for patients, bolstering clinical decision-making allowing pathologists to analyze confidently. Because DP provides additional information that helps enable precise diagnosis and identify more of your patient population, integration of an algorithm into your strategy stretches your CDx collaboration further.

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CDX DEVELOPMENT PROCESS

ABOUT ROCHE CDx

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CDx Development

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Assay Portfolio

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  • On-market assays
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