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Theradiag Gets CE Marks for Four New Biotherapy Monitoring Test Kits

NEW YORK — French diagnostics firm Theradiag said on Monday that it has received CE marks for four of its i-Tracker biotherapy monitoring test kits.

The newly CE-marked kits include i-Tracker Vedolizumab, i-Tracker Anti-Vedolizumab, i-Tracker Ustekinumab, and i-Tracker Anti-Ustekinumab, which are used to monitor the levels of drugs used to treat chronic gastrointestinal inflammatory conditions including Crohn's disease and ulcerative colitis.

The kits are designed to run on Theradiag's i-Track 10 testing system and the IDS-iSYS automated analyzer from Immunodiagnostic Systems. About a year ago, Theradiag receive CE marks for its first four i-Tracker biotherapy monitoring test kits. 

"We now have eight innovative test kits ready for market, all of them compatible with our i-Track 10 platform," Theradiag CEO Bertrand de Castelnau said in a statement. "By covering more conditions, this extension to the range is a further step in the development of individual therapeutic monitoring of even more biotherapies."