NEW YORK – ProciseDx said Tuesday that it has received US Food and Drug Administration de novo marketing authorization for its point-of-care tests to monitor levels of infliximab and adalimumab in patients during treatments for inflammatory bowel diseases.
The San Diego-based firm said it is aiming for US commercialization during the current quarter of its Procise ADL test to quantify adalimumab concentrations and Procise IFX test to quantify infliximab concentrations. ProciseDx, which was recently acquired by French diagnostics firm Biosynex, plans to launch the tests in collaboration with Chembio Diagnostics, which Biosynex also acquired in April.
ProciseDx's point-of-care assay platform measures drug concentrations in serum using time-resolved measurement of fluorescence with fluorescence resonance energy transfer (TR-FRET).
"Currently, results for drug concentrations for infliximab and adalimumab take days and require shipment to expensive third-party laboratories," ProciseDx CEO Larry Mimms said in a statement. "The ProciseDx platform will change that with a simple workflow producing a reliable quantitative measurement in five minutes or less."
Adam Cheifetz, professor of medicine and director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center, added that therapeutic drug monitoring (TDM) has become the standard of care for treatment of patients with inflammatory bowel disease and personalized dosing can improve outcomes.
"These first FDA-cleared tests for infliximab and adalimumab can improve access to TDM for patients by enabling immediate testing," he said.
ProciseDx received CE marking for its Procise ADL and Procise IFX immunoassays in September 2020.