Late-stage biopharma
From validation to the marketplace
Accelerate your path to CDx commercialization
Leverage our established global testing infrastructure, expert regulatory guidance, and custom analysis and reporting to streamline your commercialization efforts.
Expert guidance
Our deep companion diagnostic development expertise can help you navigate the regulatory landscape with confidence and accelerate your path to commercialization.
Extensive experience navigating PMA/CDx process, playing a role in 60% of all FDA-approved CDx, from targeted therapies to immunotherapies to advanced cell and gene therapies
Inhouse CRO with unmatched global capabilities
Kits are manufactured under design control to comply with US FDA, EU IVDR, and ISO standards (ISO13485:2016), as well as +CAP/CLIA compliance with ISO certs
Global infrastructure
Our established global infrastructure offers both central lab services and kitted solutions to facilitate and scale your commercialization efforts.
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Global patient access and distribution with tissue and liquid IUO CGP kits
Access to performance indicators for investigators at 61,000+ clinical trial sites in 85+ countries, enabling appropriate site selection for your studies
Access to global footprint of labs
A tissue test that is FDA cleared and a CE-marked CGP kit
Kitted solutions that are easy to implement and use in any lab in any geography
Infastructure to support global commercialization, including sales, medical affairs, and market access
Consultative approach
We are equipped and committed to provide tailored solutions that meet your needs from retrospective analysis to custom clinical trial reporting.
Nimble collaboration, including custom prospective clinical trial analysis and reporting, custom assay support, and clinical trial assay support
Have the capabilities and infrastructure to implement any technology that will serve our partners
Biopharma Services
See how we expedite biomarker-driven drug development from discovery to global CDx commercialization.