Assay Development Services

Primerdesign are experts in molecular diagnostic assay development. We have conducted many successful projects with leading diagnostic and biotechnology companies. Please contact us to enquire about how we can assist with the following services:

  • Assay design and development
  • Increasing assay content and product catalogues for diagnostic companies (any platform)
  • All probe chemistries (Hydrolysis probes, Hybeacon, PerfectProbe, Scorpion etc)
  • Assay prototype testing
  • Assay verification and validation (analytical and clinical)
  • MDx product development
  • Manufacturing (ISO13485 compliant)
  • Dispensing and lyophilisation (IVD kits)
  • Assistance with regulatory approval of MDx assays including construction of the Design History File (DHF)
 

Primerdesign’s reagents and kits are manufactured to the highest standards within our ISO13485 quality management compliant facility. You can download our MDx development services brochures by clicking here.

Assay and Product Development

The Primerdesign team have a vast experience of molecular diagnostic test development. As well as developing hundreds of our own products, we are the engine for the development of novel molecular diagnostic tests and technologies for a number of other organisations. We can take your technology at any stage of the development process and add value by conducting the following services:

  • Prototype testing
  • Assay optimisation
  • Assay verification and validation (analytical and clinical)
  • Third party validation

Product Manufacture

We can manufacture your product ready for distribution. Our facilities are purpose built for molecular diagnostic kit assay development, dispensing and manufacturing. We provide:

  • SOPs, product handbooks and QC protocols
  • ISO13485 compliant manufacturing
  • Fully branded packaging or white label
  • Manufacturing (ISO13485 compliant)
  • Dispensing and lyophilisation (IVD kits)
  • Assistance with regulatory approval of MDx assays including construction of the Design History File (DHF)

New Test Development

We have a vast experience in new test development. We develop many hundreds of assays each year for a wide variety of applications. Every design project is led by a genuine expert from start to finish. We have an outstanding reputation with our clients for our expertise and excellent communication structures that we have in place. This ensures that project delivery is on time and on budget whilst our clients maintain complete visibility of the process.

Our areas of particular expertise include:

  • Infectious disease detection in humans
  • Pathogen detection in plants and animals
  • Companion diagnostic tests
  • SNP genotyping and rare mutation detection
  • Gene expression and assays
  • Water contamination tests
  • Food contamination tests
  • GMO detection
  • Meat speciation tests
  • Bio-threat detection
  • Genetic testing/gene modification

In 2009, Primerdesign created the first assay for H1N1 Swine Flu which resulted in media coverage. You can view the news report here.


For more details on our assay development and manufacturing services, please contact our Business Development Director, Dr Ben Reed, Email: benjamin.reed@primerdesign.co.uk, Telephone: 44 (0) 23 8074 8830