Planning For Success: Development Of Diagnostic Assays For Gene Therapies

In this video, Deb Phippard, Global Head, Research discusses -  

  • Gene therapy assays
  • When does an assay become a diagnostic?
  • Navigating the regulatory jargon:  LDT, IVD, IDE, PMA, and more
  • Diagnostic assay implementation
  • Commercialization considerations for rare disease assays


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