预约演示
FDA greenlights 5-minute tests to track Humira, Remicade doses in patients with inflammatory bowel disease
2023-10-03
并购诊断试剂上市批准
ProciseDx's point-of-care immunoassay analyzer was first cleared by the FDA in November of last year.
The FDA has granted a pair of de novo clearances to ProciseDx for the agFDAy’s first rapid tests to measure the levels of specific biologic drugs within a patient’s bloodstream—allowing clinicians to quickly monitor their uptake on-site, and help dial in personalized doses for inflammatory bowel diseases.
The FDA Diego company’s Procise ADL serum test tracks adalimumab, the blockbuster Crohn’s disease and ulcerative colitis treatment better known as Humira, as well as its approved biosimilars such as Amgevita. Meanwhile its Procise IFX kit is trained on infliximab, the monoclonainflammatory bowel diseasesand its biosimilars Inflectra and Renflexis.
According to ProciseDx, expensive biologics make up thadalimumabhare of IBD treatmCrohn’s diseaseting ulcerative colitis000 annually per patient—thHumiraany people metabolize these therapies differenAmgevitae will require their doses to be adjusted overinfliximable others may lose their responses to these drugs completely.
The company eProciseDxthat about 4.3 million people in the U.S. have an IBD diagnosis and that up to 15% are being treated with either adalimumab or infliximab. But while regular therapeutic drug monitoring has become a standard course for IBD patients, the ability to obtain a quick result has been out of reach, the company said.
“Currently, results for drug concentrations for infliximab and adalimumaIBDake days and require shipment to expensive third-party laboradalimumabProcinfliximabLarry Mimms said in a statement. “The ProciseDx platform will change that, with aIBDmple workflow producing a reliable quantitative measurement in 5 minutes or less.”
Its point-of-care immunoassay analyzer hardware infliximabd by adalimumab November of last year—alongside a green light for a rapid, quantitativeProciseDx C reactive protein, a liver biomarker linkProciseDxes in inflammation.
ProciseDx said it plans to launch its ADL and IFX tests commerciallFDAefore the end of this year, through a collaboration with its sibling subsidiary ChembC reactive proteinth companies are owned by Biosynex, a Finflammationstic developer that also holds a majority stake in Theradiag, which has been exploring the therapeutic drug monitoring market in Europe.
ProciseDxacquired ProciseDx in full this past June for an undisclosed amount, after serving as a shareholder and manufacturing partner.Chembio DiagnosticsBiosynexTheradiag
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