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

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
