Our capabilities
We offer end-to-end expertise from assay chemistry to instrument engineering. We have a strong track-record in helping customers in reliable manufacturing with predictable quality. We have strong regulatory understanding including ISO 13485, ISO 14971 and CE-IVDR and a collaborative approach to ensure success.
Development path
Whether you want to test the feasibility of your initial concept, need professionals to speed up research and development activities or are looking for a reliable partner in routine manufacturing – we are here to help! All is done with emphasis on flexibility to support any phase of your development journey.
Partner with us
Explore our other services including custom manufacturing, different detection technologies, and instrument solutions. We are a trusted partner for companies and research groups worldwide!
Why Partner With Uniogen?
We combine biochemical expertise, analytical rigor, and system‑level understanding to deliver high‑performing assays designed for real‑world use. We offer:
- Deep expertise across immunoassays, lateral flow and instrumentation including mechanics, electronics, software and optics
- Flexibility to support any phase of your development journey
- Reliable manufacturing with predictable quality
- Strong regulatory understanding reducing project risk
- Collaborative approach for successfult project execution
Insights & References
Driving Innovation Together: Inside Uniogen’s Assay Development Services
At Uniogen, our Contract Development and Manufacturing Organization services help companies accelerate product development. To provide an inside look at what makes these partnerships successful, we spoke with Jiri Vainio, our Senior R&D Scientist.
GenomEra® Dry-Reagent Chemistry –Remove the bottlenecks in PCR testing
Readily established, patented Dry-Reagent chemistry with convincing performance in IVD testing for 10+ years. Extraction-free, lyophilization-free and fully scalable – no requirement for special instrumentation. Proven 5-plex RT-qPCR compatibility. Availabble for licensing.
Testimonials
“The ongoing collaboration with Uniogen’s diagnostic assay development team has been very fruitful and enabled the maturation of our assay concept from its early drafts to a soon to be launched product.” – Dag Christiansen, CEO, CardiNor