Clinical trial assays often change over the course of a trial, requiring a diagnostic partner that can closely manage these changes.
Our Specialty Laboratories have experience with assay development, validation, bridging and regulatory interactions, which are critical to the success of therapeutic programmes. Moreover, we collaborate with clients to manage risks, timelines and budgets to effectively move trials forward.
Clinical Trial Assay and IVD Development
MolecularMD’s development services segment is oriented around the development, validation, and regulatory approval of companion diagnostics, providing high-quality biomarker diagnostic services that support the registration of oncology therapeutics. Upon biomarker selection, MolecularMD has experience designing FDA CFR Title 21 Part 820-compliant assays across multiple diagnostic providers’ IVD platforms. We manage the full PMA/investigational device exemption (IDE) submission process through FDA approval via scientific/technical expertise and dedicated project and quality assurance/regulatory teams.
Our Advanced Diagnostics Division provides custom oncology clinical trial assay development and bioinformatics support using validated NGS panels which can generate endpoint and exploratory data. In addition, our team is responsible for ddPCR and liquid biopsy services.
The robust diagnostic assays developed and/or optimised are deployed for diagnostic, stratification and monitoring applications. Programme managers facilitate cross-functional teams to ensure efficient tech transfers and organise comprehensive documentation to support potential regulatory filings. Key features include:
- Demonstrated proficiency on platforms for NextGen Sequencing, Droplet Digital PCR (ddPCR), RT-qPCR, qPCR and Sanger Sequencing
- On-site access to prominent instrument manufacturers
- Partnership agreements with instrument manufacturers for a high level of technical and regulatory support
- Proficiency with pre-analytical analyte isolation, qualification and quantification from all tissue types (i.e., blood, plasma, PBMCs, solid tumor (FFPE and fresh frozen))
- Development of rigorous audit-defensible documentation and software validation