A ProciseDx analyser and assay. Credit: ProciseDx Inc/PRNewswire.

ProciseDx has obtained de novo clearance from the US Food and Drug Administration (FDA) for its therapeutic drug monitoring (TDM) tests for drugs adalimumab (Humira and biosimilar Amgevita) and infliximab (Remicade and biosimilars Inflectra and Renflexis).

Procise ADL and Procise IFX assays are intended for quantifying adalimumab (ADL) and infliximab (IFX) in patients suffering with inflammatory bowel diseases (IBD).

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Designed to be performed using serum, the tests generate a quantitative result within five minutes.

Based on time-resolved fluorescence (Förster) resonance energy transfer immunoassays, the Procise TDM assays can determine drug levels in patients undergoing infliximab and adalimumab therapy.

The assays leverage the patented ProciseDx Analyser and Lumiphore chemistry to determine the drug levels.

The ProciseDx technology allows on-site TDM testing in laboratories at hospitals and clinical laboratories.

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ProciseDx CEO Larry Mimms said: “Currently, results for drug concentrations for infliximab and adalimumab take days and require shipment to expensive third-party laboratories.

“ProciseDx enables physicians and hospital laboratorians to take control of biologics TDM through on-site testing.”

The company plans to commercially launch these drug monitoring tests in the fourth quarter of this year.

As per the Crohn’s and Colitis Foundation’s cost study, biologics such as Humira and Remicade are the significant drivers of expenses in IBD treatment. Drug costs for these patients using biologics are between $20,000 and $60,000 per annum.

In November last year, the company secured approval from the FDA for the ProciseDx analyser and the immunoassay for C-Reactive protein (CRP).

ProciseDx assays, which have a CE Mark, have been sold for TDM tests in Europe and the Middle East since 2021.