IVD CDMO & Technology Platforms

Integrated development and manufacturing of diagnostic solutions, powered by proprietary biomaterials.

From Concept to Commercialization

End-to-End Execution

Certest operates across the full IVD lifecycle.

R&D

Biomaterial
Design

Assay
Development

Validation &
Optimization

Regulatory
Compliance
(IVDR)

Technical
Documentation

CE IVDR
Certification

Manufacturing

Scale-up &
Industrial
Manufacturing

Quality
Control

Commercialization

Product
Launch

Market
Access

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)

75+ IVD / IVDR compliant products

Fully automated manufacturing environments

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

RT-qPCRNGS

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

Proprietary Biomaterials Engine

Certest develops and manufactures critical biomaterials in-house, including antibodies, antigens, enzymes and oligonucleotides, ensuring full control over performance, scalability and supply.

This vertical integration ensures:

  • Consistent performance
  • Full control over assay design
  • Secure supply
  • Rapid optimization
Core
Engine
Antibodies
Probes
Primers
Antigens
Enzymes

Biomaterial design and development

Expert engineering of highly specific and sensitive materials.

Production and optimization

Scalable synthesis from mg to industrial volumes.

Analytical characterization

Stringent QC ensuring lot-to-lot consistency.

Stability and formulation

Expertise in lyophilization and liquid stabilization.

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

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