Mature Quality Environment
Reliable IVD manufacturing only happens with an experienced team and a mature quality environment. At Veracyte, we have both the people and the processes in place to manufacture complex assays and high-quality components.
Products can be developed, manufactured and controlled in compliance with 21 CFR Part 820 & ISO 13485

Full-coverage IVD Manufacturing Capabilities
Manufacturing
- Positive/Negative control materials
- Custom plasmids
- RNA
- DNA
- Process control materials
- Cells in preservative buffer
- FFPE and TMA controls
- Purified monoclonal antibodies
QC
- Quality control process design
- Process optimisation
- Incoming QC
- Finished goods
- Raw materials QC
- Semi-finished goods
- Trending & monitoring
- Stability studies
Assay & Process Transfer
- Industrialization of new products (design transfer) or processes
- Know-how transfer
- Process and method validation
- Data center & information storage with secured external access
Supply Chain
- Short Delivery time
- Full traceability managed through ERP system
- Warehouses at -20°C, 4°C & room temperature
>110
Assays
>550
Components