Frequently asked questions
What is the timeline to develop a CDx with Roche?
Every program is unique, but typically it is approximately 12-18 months, depending on factors such as indication, prevalence and assay validation status.
When in our drug development process should we start thinking about a diagnostic strategy?
As early as possible. It is best to engage us prior to or when planning Phase 1 trials.
Are previously established assays available for other partners?
Yes, our open collaboration model has allowed us to build an extensive library of validated assays that are available and accessible to our partners.
Can you develop a prototype assay or CDx with a proprietary antibody?
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.
Can we use a prototype assay to select patients for a non-registrational study?
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.
How many labs are equipped to run your assays globally?
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.
How does Roche CDx work in China considering their unique restrictions and registrational processes?
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.
How does Roche support getting our test into the right hands to ensure patients have the earliest access to our drug upon approval?
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.
How do we start the process, and what if we aren’t sure yet what diagnostic approach to take?
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.
