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, for patients with inflammatory bowel disease (IBD). These tests are the first of their kind authorized by the FDA for these biologic therapies. The tests aim to optimize the care of IBD patients by enabling immediate testing.
The Procise ADL and Procise IFX assays quantify drug levels of adalimumab or infliximab in IBD patients using time-resolved fluorescence resonance energy transfer immunoassays. The tests can be performed onsite in hospitals or clinical labs, providing results in 5 minutes or less. ProciseDx plans to commercialize these tests by the end of 2023.