NEW YORK – Theradiag said on Monday that it has received CE marks for the first four i-Tracker test kits in its Tracker range.
The CE-marked kits are the i-Tracker infliximab; i-Tracker Anti-Infliximab; i-Tracker Adalimumab; and i-Tracker Anti-Adalimumab. The CE-market kits are the i-Tracker infliximab; i-Tracker Anti-Infliximab; i-Tracker Adalimumab; and i-Tracker Anti-Adalimumab. Each is for the biomonitoring of biologics for rheumatoid arthritis, ulcerative colitis, psoriatic arthritis, and other disorders. They are compatible with the i-Track automated analyzer for biotherapy monitoring, which received CE marking in late 2019.
According to Marne-la-Vallée, France-based Theradiag, the kits have been redesigned to be more user friendly and reliable when used on the i-Track analyzer. They provide precise results, as well as quantification over a broad measurement range, simpler use, and enhanced platform productivity.
Concurrent with their CE marking, the kits were launched and have been registered with the French National Drug and Health Product Safety Agency, Theradiag said.