Both the therapeutic drug monitoring tests are intended to monitor biologic drugs Humira, Remicade, and their biosimilars at point-of-care in moderate complexity clinical laboratories and hospitals
An image of ProciseDx analyser and assay. (Credit: PR Newswire/ProciseDx)
ProciseDx has secured de novo clearance from the US Food and Drug Administration (FDA) for its Procise ADL and Procise IFX tests to monitor levels of adalimumab and infliximab in patients taking these drugs for inflammatory bowel diseases (IBD).
Both the therapeutic drug monitoring (TDM) tests are intended to monitor biologic drugs Humira, Remicade, and their biosimilars at point-of-care.
The US-based in vitro diagnostics (IVD) company has designed these tests for use in moderate complexity clinical laboratories and hospitals.
According to ProciseDx, the tests can be executed using serum or finger prick blood sample or a stool sample and take only five minutes to deliver a quantitative result. The assays are based on time-resolved fluorescence (Förster) resonance energy transfer immunoassays.
By using the patented ProciseDx Analyzer and Lumiphore chemistry, the tests evaluate the drug levels in patients receiving infliximab and adalimumab therapy.
The ProciseDx technology also allows on-site TDM testing in clinical laboratories and hospitals with moderate complex labs, the IVD company said.
ProciseDx CEO Larry Mimms said: “Currently, results for drug concentrations for infliximab and adalimumab take days and require shipment to expensive third party laboratories.
“The ProciseDx platform will change that, with a simple workflow producing a reliable quantitative measurement in five minutes or less.
“ProciseDx enables physicians and hospital laboratorians to take control of biologics TDM through on-site testing.”
ProciseDx, which was acquired by French diagnostics firm Biosynex earlier this year, aims to market the drug monitoring tests in Q4 2023.
It will introduce them in the US markets in partnership with Chembio Diagnostics, which is also part of Biosynex.
The company received FDA clearance for the ProciseDx analyser and its first immunoassay for C-reactive protein (CRP) in November last year.
Since 2021, the CE-marked ProciseDx assays with on-site, five-minute assays on the ProciseDx analyser are being sold for TDM tests in Europe and the Middle East.