Companion Diagnostics Assay Commercialisation

 

Assay Commercialisation

Successful assay commercialisation is extremely important for successful adoption of a new diagnostic test. Critical issues include:
  • Regulatory requirements of the target market(s)
  • Does the assay meet the performance requirements set out by the biomarker, the sample type and the customers?
  • Should the assay be commercialised as a product, a service, or both?
  • How do the customers get access to the product and/or service?
  • Does the assay provide value for the healthcare provider, the payor, the manufacturer and the distributor?
  • Is the assay platform, format and package size convenient for the customers?
  • What are the sample type, shelf life and required shipping and storage conditions?
  • What is the most suitable distribution strategy?
  • What is the Sales & Marketing strategy?
As for any product, thorough knowledge of the target market is extremely useful in getting the commercialisation process right.

Lab21 has commercialised over 70 regulatory approved diagnostic products, has a global diagnostic product distribution network covering over 115 countries, and provides specialist diagnostic services to clinicians and healthcare provides worldwide from its accredited clinical laboratories in the UK (CPA, incorporating ISO 15189) and the US (CLIA). We are an extremely strong partner for commercialisation as well as development and manufacture of biomarker assays. Our manufacturing quality standards include ISO 9001, ISO 13485 and GMP.

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