Frequently asked questions
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 installed base of IHC staining platforms, with over 10,000 BenchMark IHC/ISH instruments worldwide and leading market share in every region.
The global Roche CDx 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 CROs and labs to process Chinese patient samples and support trials.
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 CDx launch strategy to your specific drug commercialization program.
We’ll start with an introductory conversation to fully understand your needs and discuss how Roche CDx can best partner with and support you. Even if your biomarker or diagnostic strategy isn’t fully developed, we can help in providing our expertise and consultative approach.