IVD services
IVD development
What we offer
We combine our strong expertise and track-record in IVD development with regulatory-compliant processes to provide a tailored IVD development service. We provide an end-to-end service covering the complete journey of an IVD assay’s development, including:
- Assay design and proof of concept
- Feasibility and prototype development (RUO)
- Assay development
- Assay industrialization
- Assay verification and validation
- Regulatory submissions
- Post market activities
Reasons to choose Veracyte
We offer a broad range of IVD development expertise and a mature, efficient, and proven design control process:
- ISO 13485
- 21 CFR part 820
We utilize of a wide range of technologies, including:
- IHC
- Digital pathology
- Molecular biology (qPCR, NGS, nCounter®, etc.)
We have a demonstrated track record of international regulatory success, including:
- CLIA
- CE-IVD marking
- FDA
- MLW/PMDA
IVD manufacturing
Veracyte enables you to rapidly scale up production with our IVD manufacturing services. We offer proven logistical, regulatory and manufacturing expertise, and quality systems to handle all or part of your IVD manufacturing needs so you can reach your market quickly and without large-scale capital investments.
Our manufacturing service supports companies during the different phases of development and commercialization, providing pilots and commercial lots in an ISO13485 certified environment.
Manufacturing
- Molecular and immunoassay control materials
- Reaction mixes preparation
- Extraction buffers
Quality control
- Quality control process design
- Personalized final and incoming QC
- Trending and monitoring analyses
- Stability studies
Assay and process transfer
- Industrialization of new products or processes
- Know-how transfer
- Process and method validation
Supply chain
- Kit assembly and packaging
- Full traceability managed through ERP system from raw material sourcing to kit release
- Monitored storage premises (-20°C, 4°C and room temperature)