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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


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…


CRO and Clinical Reference Laboratory Commercial Incentives

One of the challenges developing a companion diagnostic is creating a test that runs well in both clinical trials, and following regulatory approval, clinical testing laboratories Unfortunately, in…


Oncology Clinical Trials During a Pandemic

2020 has really been a year that doesn’t quit, hasn’t it? The dangerous part of COVID-19 has been how rapidly it has overwhelmed our healthcare system, in particular, how it has affected cancer…
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