CDx Overview

PrimeraDx is a molecular diagnostic manufacturer with full service companion diagnostic (CDx) product development capabilities. We work in partnership with drug developers to:

• Design, develop and validate custom CDx tests
• Support drug development with CDx tests through our designated laboratory partners
• Achieve registration for the targeted therapy and the corresponding CDx test by working with global regulatory bodies.

PrimeraDx’s next-generation real-time PCR platform, ICEPlex, is unique. The ICEPlex System allows for far greater multiplexing than possible with other qPCR systems. For example, a genotyping test for twenty (20) mutations would require no less than five (5) tubes in a conventional qPCR system whereas the ICEPlex System can perform the entire reaction in a single reaction tube. This, along with probe-free amplification chemistry, allows for simpler assays that are easier to develop, validate, manufacture and present to regulators.

Benefits of Working with PrimeraDx

Flexible partnership – Structure to match drug development efforts, and have support capabilities to ensure smooth communication, project management and avoid delays

Reduction of risk – PrimeraDx develops IVD-track assays, so when used for biomarker validation in Phase I/II studies, PrimeraDx research assays reduce risk of discordance with companion diagnostic tests used in registrational drug trials

Streamlined Approval – By running a complex multi-analyte assay in one well of one platform, PrimeraDx has set the stage for a streamlined FDA Approval

Seamless Clinical Trial Launch – Existing relationships with CROs reduces time delays associated with selecting and equipping a designated laboratory

Structure of Partnerships with PrimeraDx

Milestones – A flat-fee milestone model instead of contemporary time-and-materials models

Drug/Diagnostic Alignment – Milestone fee schedule aligned with drug development; PrimeraDx programs fully integrate with clinical development

Regulatory – Program governance, management and regulatory teams are experienced negotiators with FDA and other regulatory bodies at all stages of the drug/diagnostic co-development process

Clinical partners – PrimeraDx has partnered with clinical trial laboratories for rapid access to clinical samples, testing of clinical trial specimens using the IUO test and demonstration of clinical utility of the companion diagnostic

A Platform Designed for CDx

Automated – A fully automated system for real-time analysis of many more analytes in the same reaction than previously possible with contemporary real-time PCR instruments

Simplifying Complexity – Simultaneously perform SNP detection / mutation profiling, establish gene copy number, quantitate mRNA and miRNA expression and conduct epigenetic profiling in the same reaction tube

Quantitative Multiplex – The only platform allowing high multiplex fully quantitative assays

Efficient – Simple reaction chemistry allows for rapid assay development while the single-tube design allows for streamlined analytical validation and minimal precious sample usage

PrimeraDx’s companion diagnostic partnerships are designed to enable drug developers to capture the value of innovative, targeted therapies by providing full diagnostic support during clinical development and commercialization.