You find the newest and actual compilation of FDA-approved companion tests here that provide information essential for the safe and effective use of a corresponding therapeutic product in given patient subgroups, a hallmark of theragenomic medicine.
According to the FDA definition, a companion diagnostic device can be an in vitro diagnostic device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. The use of an IVD companion diagnostic device with a particular therapeutic product is stipulated in the instructions for use in the labeling of both the diagnostic device and the corresponding therapeutic product, as well as in the labeling of any generic equivalents and biosimilar equivalents of the therapeutic product.
On this site here, you find an excerpt of selected test from the full FDA-list here.
The page was last updated on July 31, 2018
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