IVD Development

Streamline in vitro diagnostic (IVD) development by partnering with Veracyte.

Whether you are developing an IVD, a CDx, or an assay for a clinical trial application (CTA), Veracyte can advance your program.

We can support you during all parts of the process, including development, manufacturing, life cycle management, regulatory submission preparation and filing, and commercialization.

IVD Development

What we offer


Why you should choose Veracyte:

  • Our core team covers a broad range of IVD development expertise
  • We use a mature, efficient, and proven design control process
    • ISO 13485
    • 21 CFR part 820
  • We can implement a wide range of technologies, including:
    • IHC
    • Digital pathology
    • Molecular Biology (qPCR, NGS, Nanostring etc..)
  • We possess a demonstrated track record of international regulatory success, including:
    • CLIA
    • CE- IVD marking
    • FDA
    • MLW/PMDA

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Contact Our Team to Discuss Your Project