In the early phase, we work with you to build a strong framework for your diagnostic strategy and ensure you are optimally positioned to proceed with a potential CDx when your drug achieves success.
Early stage development
Antibody development
Whether developing a customized antibody or screening commercially available antibodies for performance characteristics that qualify for the reagent manufacturing process, we can engage early to help mitigate delays and ensure IVD readiness.
Prototype assay validation
An experienced team of scientists and functional experts will design and develop a fully optimized robust prototype assay based on your drug development strategy and implement it into one of our CAP/CLIA-accredited laboratories for exploratory clinical testing.
Biomarker testing
Our Global CAP/CLIA-accredited laboratories uniquely enable us to quickly and efficiently utilize the robust prototype assay in early-stage clinical trials. Our dedicated Clinical Science Management team provides study planning and execution, as well as IDE and IVDR support in collaboration with our CDx Regulatory Affairs team.
Early stage development
Discover your research potential
We develop innovative IHC/ISH and digital pathology, clinical and immunochemistry, PCR and NGS technologies that empower researchers. Our instrument and protocol flexibility allows for exploration of the most challenging assays. Accelerate the discovery of new targets and biomarkers, speed assay development, and target validation using Roche products.
Complete pharma services and support
CAP/CLIA exploratory testing
Our CAP/CLIA-accredited laboratories are located in Tucson, San Jose, and Europe. We have capabilities to test patient samples in-house and partnerships to run samples in China as well.
Seamless clinical trial support
Expert management of complex clinical studies maximizes probability of success, while strong relationships with leading clinical research organizations (CROs) ensure a seamless transfer to registrational trials.
Track record of success
Our comprehensive pharma services model has delivered success for 200+ partners over 25 years.