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.

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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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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.

View Full Table

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.