At Roche Personalised Healthcare Solutions (PHCS), we help to advance personalized healthcare by delivering diagnostic confidence through a broad menu of high medical value assays. Partners can benefit from access to more than 500 non-exclusive assays spanning twelve disease areas and growing, connecting you to innovative solutions that are already performing in today’s market. Our CAP/CLIA labs in Tucson, San Jose, and Europe also support testing for a menu of 90+ clinical trial-ready assays and mutliplex panels, including many important emerging biomarkers.
On-Market Assays
With more high medical value assay approvals achieved than any other company, we hold a reputation for success that makes us the global diagnostic partner of choice for pharmaceutical companies. We are the only diagnostics provider with centralized expertise across multiple technologies including IHC/ISH, clinical and immunochemistry, PCR and NGS. Explore our on-market assay portfolio:
FEATURED BIOMARKER
“Trophoblast cell surface antigen 2 (TROP2) has emerged as a therapeutic delivery target in non-small cell lung carcinoma (NSCLC). However, its use as a predictive biomarker by conventional immunohistochemistry (IHC) has proven challenging. Quantitative Continuous Scoring (QCS), a fully-supervised computational pathology algorithm, has demonstrated the ability to predict NSCLC patient response to a TROP2 targeting antibody-drug conjugate (ADC) by quantifying TROP2 protein expression on digitized IHC slides.”
Quote from Lopez-Rios, F. et al. Real-World Assessment of TROP2-NMR by Quantitative Continuous Scoring (QCS) in Non-Small Cell Lung Carcinoma (NSCLC). Journal of Thoracic Oncology, Volume 20, Issue 10, S29 - S30. https://www.jto.org/article/S1556-0864%2825%2901110-4/abstract.
8 September 2025.
Assays customized to your needs
Robust prototype assay (RPA)
Allows biomarker hypothesis testing in early phase trials with no immediate CDx development need. Offers flexibility for use in further research, with a shorter development duration.
Formulation locked assay (FLA)
Allows biomarker hypothesis testing during early phase clinical studies with intent of transitioning to a CDx. Hybrid approach establishes assay feasibility and minimizes risk.
Investigational use only assay (IUO)
For biomarker validation testing to support registrational clinical studies and health authority submissions.
Non-registrational assay menu
We offer a broad range of assays to support early-phase and non-registrational trials, which includes many important emerging biomarkers as well as multiplex panels. This list is non-exhaustive, and our capabilities are ever-evolving, so if you don’t see your biomarker of interest here, just ask.
Biomarker |
Technology |
|---|---|
ALK |
IHC |
aSyn |
MPx |
ATM |
IHC |
AXL |
IHC |
B7H3 |
IHC |
B7H4 |
IHC |
B7H6 |
IHC |
CD8 |
IHC |
CD30 |
IHC |
CDH6 |
IHC |
CEA |
IHC |
CLDN6 |
IHC |
CLDN18 |
IHC |
CLDN18.2 |
IHC |
cMET |
IHC |
DLL3 |
IHC |
EGFR |
IHC |
FAP |
IHC |
FGFR2b |
IHC |
FOLR1 |
IHC |
GPC3 |
IHC |
HER2 |
IHC/ISH |
HER3 |
IHC |
LAG3 |
IHC |
LIV1 |
IHC |
MMR |
IHC |
MSLN |
IHC |
MTAP |
IHC |
MUC16 |
IHC |
PD-L1 |
IHC |
PTEN |
IHC |
TIGIT |
IHC |
TROP2 |
IHC |
Myostatin |
Immunoassay |
sGPC3 |
Immunoassay |
BRAF/NRAS |
qPCR |
KRAS |
qPCR |
PIK3CA |
qPCR |
Technologies
Roche PHCS is the only provider able to draw upon a wide range of technologies — IHC/ISH and digital pathology, immunochemistry, PCR and NGS — to tailor a customized solution for your diagnostic program, offering flexibility to support whatever your strategy requires.
Registrational assay menu
We offer a broad range of investigation/registration-ready (IUO) assays supported in our labs, which includes many important emerging biomarkers. This list is non-exhaustive, and our capabilities are ever-evolving, so if you don’t see your biomarker of interest here, just ask.
Biomarker |
Technology |
|---|---|
| ALK | IHC |
| B7H4 | IHC |
| CD30 | IHC |
| CLDN18 | IHC |
| CLDN18.2 | IHC |
| CLDN6 | IHC |
| FGFR2b | IHC |
| FOLR1 | IHC |
| HER2 | IHC |
| HER3 | IHC |
| MET | IHC |
| MMR | IHC |
| MSLN | IHC |
| PD-L1 (SP263) | IHC |
| PD-L1 (SP142) | IHC |
| PMS2 | IHC |
| PTEN | IHC |
| TROP2 | IHC |
| AFP | Immunoassay |
| AFP-L3 | Immunoassay |
| ApoE4 | Immunoassay |
| GDF-15 | Immunoassay |
| HE4 | Immunoassay |
| IGFBP-3 | Immunoassay |
| Lp(a) | Immunoassay |
| OPN | Immunoassay |
| PIVKA-II | Immunoassay |
| ProC3 | Immunoassay |
| ProC3X | Immunoassay |
| ProGRP | Immunoassay |
| pTau181 | Immunoassay |
| pTau217 | Immunoassay |
| sTREM1 | Immunoassay |
| BRAF | qPCR |
| EGFR | qPCR |
| EZH2 | qPCR |
| KRAS | qPCR |
| PIK3CA | qPCR |
Why digital pathology?
Diagnostic assays are answering more complex questions than ever before. Our fully integrated navify® Digital Pathology solution allows pathologists to analyze confidently, and delivers new value for patients by increasing precision diagnoses with digitization and AI-based decision support.
AI-powered digital pathology algorithms can help identify more of your patient population. Partners can leverage Roche's broad digital pathology expertise to advance their precision medicine strategy with image analysis algorithm development, ensuring integration of their diagnostic with the latest in digital pathology solutions.