Roche Personalized Healthcare Solutions (PHCS)

An early prototype assay (ePA) is developed in the pre-clinical/research/pre-investigational new drug (IND) phase. Assay utilization includes biomarker characterization and expression in tumor and normal tissue and in cell line or animal models and prevalence. It is not developed under design control, typically takes around two months to develop, and is tested in house at Roche.

A robust prototype assay (RPA) is developed in the research/pre-IND phase and supports Rx registrational trials. Assay utilization includes biomarker hypothesis testing in early phase trials. It is not designed for Dx registrational trials and is not developed under design control. It typically takes around four months to develop and is tested in the Roche CAP/CLIA labs (excluding China).

A formulation locked assay (FLA) is also developed in the research/pre-IND development phase and supports Rx registrational trials. Assay utilization includes biomarker hypothesis testing in early phase trials. It is not designed for Dx registrational trials (bridging to Investigational Use Only (IUO) is required), is formulation locked for CDx IUO, and is developed under design control. It is tested in the Roche CAP/CLIA labs (excluding China), and typically takes around nine to 12 months to develop.

An investigational use only (IUO) assay supports drug registrational trials, is designed for diagnostic registrational trials, and is developed under design control. It is tested in pharma-selected labs globally, including Roche CAP/CLIA labs with the exception of China. Typical development duration is between 18 and 24 months.

Roche is a global organization with the industry's most extensive affiliate network, active in more than 100 countries. This allows us to tailor our launch strategy to your specific drug commercialization program.

We'll start with an introductory conversation to fully understand your needs and discuss how Roche PHCS can best partner with and support you. Even if your biomarker or diagnostic strategy isn't fully developed, we can help by providing our expertise and consultative approach. Contact us now to start the conversation.

 Every program is unique, but typically it is approximately 12-18 months, depending on factors such as indication, prevalence and assay validation status.

As early as possible. It is best to engage us prior to or when planning Phase 1 trials.

Yes, our open collaboration model has allowed us to build an extensive library of validated assays that are available and accessible to our partners.

Yes, we are glad to work with our pharma partners' proprietary antibodies with the understanding that if a CDx assay is to be developed, a licensing agreement would need to be established.

Yes, a robust prototype assay (RPA) can be ideally tailored to select patients for non-registrational studies via our CAP/CLIA lab with additional validation and quality efforts.

We have the largest install base of diagnostic instruments and platforms, with >14,800 BenchMark IHC/ISH instruments, >89,000 cobas analyzers, >47,000 cobas Immunoanalyzers, and >15,000 cobas digital PCR instruments worldwide.

The global Roche PHCS team works closely with the Roche China Diagnostics affiliate to ensure successful and consistent CDx development while abiding by China-specific regulations. We partner with leading clinical research organizations (CROs) and labs to process Chinese patient samples and support trials.