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NeoGenomics is proud to support multiple companion diagnostic (CDx) programs with our Pharmaceutical, Biotechnology, and In Vitro Diagnostic partners.

A focus on personalized medicines and immune-modulating drugs has given rise to biomarker-focused oncology clinical studies. The use of biological signatures to identify patients that will benefit from a particular therapy has greatly accelerated the pace of drug development and approval. Simultaneously, it has complicated drug development by requiring the co-development of a CDx diagnostic test to accurately and reproducibly select patients that will benefit from said therapy. With experience in more than 70 programs as of Jan 01 2020, and more than 30 active programs with pharmaceutical sponsors and IVD Companies, NeoGenomics has been a key player in this new approach to oncology drug development. We don’t just provide testing services. We offer a consultative approach to CDx development and commercialization.

With known development and regulatory expertise NeoGenomics has created defined processes associated with each aspect of development that involves coordinated efforts in the areas of Consultation; Customization; Commercialization; and Consolidation. Development of companion diagnostics is complex and time consuming. Our team of scientists, pathologists, and business development professionals are here to help.

  • Consultation
    • Technology agnostics platform selection
    • CDx study design
    • Regulatory consultation
    • Commercialization strategy
    • Pathology expertise across multiple disciplines
    • Scientific expertise across multiple technology platforms
  • Customization
    • De novo assay development
    • Fit-for-purpose validation
    • Global harmonization of custom assays across multiple testing sites
    • Project, data, and regulatory management
  • Commercialization
    • NeoGenomics is the largest oncology-focused laboratory in the USA
    • Established relationships with major IVD providers
    • Single site FDA-approved test approvals and partnerships for Ex-USA launch
    • Day One Launch program
    • Sponsored Testing programs
    • Data services
  • Consolidation
    • Consolidate CDx and specialty testing with one CRO

Latest News


Is It Validated?

NeoGenomics has a menu of >600 assays across many different technologies and approaches. Clients often approach us after searching our menu online and ask if we can “Provide Test X for Clinical…


A spotlight on CDx development

NeoGenomics will share several posts focusing on CDx development. We will be launching an occasional updated blog covering our thoughts, musings, and opinions on personalized medicine.Or other topics…
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