IVD Manufacturing

Rapidly scale up production with IVD contract manufacturing from Veracyte

The same proven logistical, regulatory, manufacturing expertise and quality systems that we use to manufacture our own products can handle all or part of your IVD manufacturing needs so you can reach the market quickly and without large-scale capital investments.

IVD Manufacturing

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


  • Positive/Negative control materials
    • Custom plasmids
    • RNA
    • DNA
  • Process control materials
    • Cells in preservative buffer
    • FFPE and TMA controls
  • Purified monoclonal antibodies


  • 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





We manufacture a wide range of assays and assay components for biopharma and diagnostics companies around the world.

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Contact our team to discuss your project