Assay Development

All our team at MedixMDx have expertise in both MDx raw material manufacturing and MDx IVD kit manufacturing.

We know your pain points and are ready to support you to ensure your commercial success – faster.

Our reagents and ready to use mastermixes or customized solutions are manufactured and formulated in line with your IVD assay and product development needs. That means that we reduce the complexity and development time for your project, so your MDx solutions get to the market more quickly.

Discuss your needs with one of our team, contact us today.

Proof of concept

  • Testing raw materials (enzymes, buffers) or mastermix testing
  • Kit, primer/probe design

R&D phase

  • Pre-clinical testing
  • Assay optimization
  • Primer/probe mastermix
    • Optimization
    • Formulation
    • Lyophilization

Verification & validation

  • Extensive performance testing
    • Stability
    • Precision
    • Sensitivity
    • Specificity
    • Clinical studies
  • Kit manufacturing readiness

Release for sale

  • Kit manufacturing
  • Registration
  • Regulatory approval
  • Sales

To learn more about how we can help you meet your unique needs, contact our team today.