In late stage development, we prepare and provide support for registrational and pivotal trials with an investigational assay, while conducting regulatory submission planning and preparation.
The assay and raw materials are validated and verified, and the investigational assay kit is developed, including the scoring algorithm, control slides and training materials.
With 250+ ongoing studies, our adeptness at clinical trial support helps our partners meet their timelines and bolster their programs’ probability of success.
We take a flexible, early approach to regulatory strategy aligned with drug timelines, drawing on our regulatory expertise to determine the best approach for each partner.
Find out how we enabled significant access to personalized therapy for cancer patients.
Our deep bench of experts includes an oncologist and 30+ pathologists who help ensure product development is informed by the latest medical and scientific developments and discoveries.
