FDA greenlights 5-minute tests to track Humira, Remicade doses in patients with inflammatory bowel disease

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来源: FierceBiotech

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 agency’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 San 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 monoclonal antibody behind Remicade and its biosimilars Inflectra and Renflexis.

According to ProciseDx, expensive biologics make up the lion’s share of IBD treatment costs—amounting to $20,000 to $60,000 annually per patient—though many people metabolize these therapies differently. Some will require their doses to be adjusted over time, while others may lose their responses to these drugs completely.

The company estimates that 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 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 5 minutes or less.”

Its point-of-care immunoassay analyzer hardware was cleared by the FDA in November of last year—alongside a green light for a rapid, quantitative test for C reactive protein, a liver biomarker linked to rises in inflammation.

ProciseDx said it plans to launch its ADL and IFX tests commercially before the end of this year, through a collaboration with its sibling subsidiary Chembio Diagnostics; both companies are owned by Biosynex, a French diagnostic developer that also holds a majority stake in Theradiag, which has been exploring the therapeutic drug monitoring market in Europe.

Biosynex acquired ProciseDx in full this past June for an undisclosed amount, after serving as a shareholder and manufacturing partner.

The company said it plans to present risk-benefit analysis data comparing its rapid tests with traditional dose escalation procedures in patients who have lost their response to infliximab, during the annual meeting of the American College of Gastroenterology this month in Vancouver.

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