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
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.
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.
Assays customized to pharma’s needs
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)
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
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.
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
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.
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.
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 |
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.
