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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


Liquid Biopsies

Despite the terminology “liquid biopsies” (LBx) becoming common place in diagnostic lexicon, as a routine clinical technology, LBx is still very much in its infancy. Liquid biopsy has a broad…


Why does IHC remain so popular for CDx development?

The topic of IHC came up recently. Specifically, why is it used so frequently for companion diagnostic development. The discussion came up during our 2020 wrap up, looking at all active CDx or CDx-…


New China operation

December 30th was an exciting day for NeoGenomics as we got the keys to our new facility in Suzhou, China. Suzhou is about 60 miles from Shanghai and is the new home for PPD and NeoGenomics newest…
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