A CDMO partner for IVD
End-to-end
Technology Platforms

From proprietary biomaterials to commercial supply, we develop and manufacture innovative IVD tests on immune and molecular platforms.

Technology Platforms

Certest combines biomaterial development, assay design, validation and manufacturing within a single integrated structure, ensuring performance, scalability and supply reliability.

End-to-end development of immunoassays supported by proprietary antibodies and antigens.

SCOPE

Lateral flowCLIAELISATurbidimetry

REAL CAPABILITIES

  • Biomaterial selection and screening

  • In-house developed antibodies, immunogens, controls & calibrators

  • In-house production of critical reagents, ensuring supply security and product consistency.

  • Proprietary technologies enabling high-sensitivity latex-based assays.

  • Assay development and optimization across lateral flow, CLIA, ELISA and turbidimetry

  • Scale-up and industrial manufacturing

Advanced molecular solutions based on in-house enzymes and oligonucleotide technologies.

SCOPE

Real Time PCRNGS

REAL CAPABILITIES

  • In-house enzyme development and optimization
  • In-house primers & probes design & optimization (including multiplex)
  • RT-qPCR workflow optimization
  • NGS workflow development
  • Lyophilized reagents & ready-to-use formats

We offer biotechnological solutions at the highest level based on our own biomaterials in the field of immunodiagnostics & molecular diagnostics.

As a CDMO, we partner with you to develop, validate, manufacture and bring to market innovative IVD tests using our proprietary biomaterials and deep technical expertise.

Our core is built on molecules that matter.

We don’t only develop IVD assays—
we engineer the biomaterials behind them.

Control of critical reagents enables control of diagnostic performance and supply reliability.

Core
Engine
Antibodies
Probes
Primers
Antigens
Enzymes

End-to-end. One partner, every step of the way.

We take care of the entire diagnostic development lifecycle so you can focus on making an impact.

01

Biomaterials

Proprietary antigens, antibodies, enzymes, oligos and controls designed and produced in-house.

02

Test development

Assay design and optimization for our IVD test across our Immuno or Molecular platforms.

03

IVDR & Regulatory

Assay validation and IVDR compliance with our expert regulatory team.

04

Manufacturing

Scalable production at ISO 13485 facilities with strict quality and supply security.

05

Product Launch

We support your market launch and sustain worldwide through our global network.

Scale, expertise and commitment to success

Stay at the heart of life, in experienced, multidisciplinary teams and a track record of innovation that raise the difference.

25,000+ m²

State-of-the-art facilities

110+

Highly specialised R&D

50+ PhDs

Multidisciplinary expert team

776+

IVD references* delivered

150,000

Tests/day production capacity

130+

Countries worldwide

Deep expertise across the entire IVD value chain

With over 20 years of experience in immunodiagnostics and advanced molecular technologies, Certest integrates biomaterial development, assay design, validation and industrial manufacturing within a single organization.

200+ IDx assays &  150+ MDx solutions developed and marketed

Dedicated in-house regulatory team

20+ years in immunodiagnostics & 10+ years in molecular diagnostics

State-of-the-art facilities with ISO 7 cleanroom environments

ISO 13485 & MDSAP certified

Industrial-scale manufacturing (>25,000 tests/day)

IVDR compliant products

Fully automated manufacturing environments

Strategic Collaboration Model

Certest engages in selected collaborations with partners requiring advanced diagnostic development and manufacturing capabilities, particularly for complex or large-scale programs.

  • Joint development initiatives
  • Integration of Certest technologies into partner platforms
  • Custom assay development / design and optimization
  • Long-term industrial partnerships

Target areas

Application Expertise

  • Infectious diseases and human biomarkers
  • Broad experience across multiple sample types: blood, urine, fecal and respiratory samples
  • Strong performance in complex biological matrices
  • Development of quantitative diagnostic solutions
  • Molecular diagnostic panels