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.

Contact Us to Discuss Your Project

IVD Development

What we offer

We combine our strong expertise and track-record in IVD development, with regulatory-compliant processes to provide the complete range of IVD, CDx, and CTA assay services, including:

  • Biomarker discovery & Proof of Concept
  • Prototype assay design (RUO)
  • Assay development
  • Industrialisation
  • Assay verification and validation
  • Regulatory submissions
  • Post launch activities
  • Manufacturing
  • Testing Services
0001

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
0001

Related Services

IVD Manufacturing

Keep your organization lean and agile by outsourcing your assay manufacturing to Veracyte.
Our spacious, state-of-the-art facilities regularly manufacture complex IVD assay’s components and operate under a mature, proven, certified, and compliant environment.

Learn More

Testing Services

Increase throughput and expand your global footprint by outsourcing your assays (NGS, qPCR, ELISA, IHC etc.) to Veracyte. We operate CLIA labs in Marseille, France, and Virginia, United States, which routinely run thousands of tests per year and have the ability to rapidly scale up.

Learn More

Contact Our Team to Discuss Your Project

Contact Us