FDA grants de novo status to ‘5-minute’ drug monitoring tests for Humira, Remicade in IBD

The FDA has granted de novo clearance to ProciseDx Inc. for its therapeutic drug monitoring tests for Humira and Remicade, as well as their biosimilars, in patients with inflammatory bowel disease, according to a company release.
These are the first therapeutic drug monitoring tests authorized by the FDA for Humira (adalimumab, AbbVie) and Remicade (infliximab, Janssen) biologic therapies, in addition to the biosimilars Amjevita (adalimumab-atto, Amgen), Inflectra (infliximab-dyyb; Celltrion/Pfizer) and Renflexis (infliximab-abda, Samsung and Merck).
“Therapeutic drug monitoring of

The FDA has granted de novo clearance to ProciseDx Inc. for its therapeutic drug monitoring tests for Humira and Remicade, as well as their biosimilars, in patients with inflammatory bowel disease, according to a company release.
These are the first therapeutic drug monitoring tests authorized by the FDA for Humira (adalimumab, AbbVie) and Remicade (infliximab, Janssen) biologic therapies, in addition to the biosimilars Amjevita (adalimumab-atto, Amgen), Inflectra (infliximab-dyyb; Celltrion/Pfizer) and Renflexis (infliximab-abda, Samsung and Merck).
“Therapeutic drug monitoring of