IVD Services

Transfer and Validate Companion Diagnostic Assays (CDx) on any platform

Personalized medicine is an evolving field  in which treatments are tailored to the individual patient. The FDA requires a companion diagnostic test if a new drug works on a specific genetic or biological target that is present in some, but not all, patients with a certain cancer. The companion diagnostic test is used to identify which patients would benefit from the use of, or who could be harmed by use of a certain drug for treatment of their disease.

The CDx process works best when development of the test begins before the drug enters clinical trials. Early collaborations between pharmaceutical companies, test manufacturers, and laboratory services can result in faster access to promising new treatments for cancer patients.

FDA-Approved Assays and FDA-Cleared Assays

NeoGenomics and its affiliates work with 6 of the 10 manufacturers of FDA-cleared Companion Diagnostic Devices
(In Vitro and Imaging Tools)*

* In Vitro and Imaging Tools 

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