(Boursier.com) — ProciseDx Inc., which is owned by Biosynexreceived de novo authorization from the FDA for dosage tests of infliximab (Remicade and biosimilars Renflexis and Inflectra) and adalimumab (Humira and biosimilar Amgevita) used in the context of therapeutic drug monitoring ( CT or Therapeutic Drug Monitoring).
ProciseDx diagnostic technology allows quantitative tests to be performed in 5 minutes for Therapeutic Monitoring of Biological Drugs. These tests are used to quantify the serum concentration of infliximab (IFX) and adalimumab (ADL) in patients with inflammatory bowel disease (IBD) treated with these medications. They are intended for hospitals and other clinical laboratories of moderate complexity.
ProciseDx will begin commercialization activities immediately and plans to ship the first instruments and kits early in Q4 2023. It plans to offer IFX and ADL assay kits in addition to IFX and ADL assay kits. CRP (inflammation marker).
Biological drugs such as Remicade and Humira are products manufactured by biotechnology and intended for the treatment of chronic pathologies. They represent the largest cost factor in treating IBD, according to a cost study by the Crohn’s and Colitis Foundation. The cost of treatment in the United States for IBD patients taking biologics is in the range of $20,000 to $60,000 per year. In the United States, 4.3 million people have IBD (Crohn’s disease and ulcerative colitis) and up to 15% of them are treated with IFX and ADL.
“Therapeutic monitoring of biotherapies is a tool that makes it possible to optimize the treatment of patients with IBD and has come into practice in the management of these patients. Personalized dosing of biological drugs can improve monitoring” indicates Adam Cheifetz, MD professor of medicine and director of the Center for Inflammatory Bowel Disease at Beth Israel Deaconess Medical Center/Harvard Medical School. “These first FDA-authorized infliximab and adalimumab dosing tests can help improve access to TDM for patients through immediate reporting of results.”
Remember that Biosynex owns 100% of the shares in ProciseDx as well as a majority stake in the company Theradiag, a pioneer in the TDM market in Europe for more than 10 years. ProciseDx received FDA clearance for the ProciseDx instrument and C-Reactive Protein (CRP) assay in November 2022. ProciseDx tests are CE marked and are marketed for CT testing in Europe and the Middle East. -Orient since 2021 with tests that can be carried out in 5 minutes to measure CRP, IFX and ADL in the blood as well as an inflammatory marker of the intestine, fecal calprotectin, in the stools.
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