Instrumentation Laboratory (IL) today announced the commercialization in Europe of their HemosIL Direct Thrombin Inhibitor (DTI) Assay. When used in conjunction with HemosIL Dabigatran Calibrators and Controls, this test offers an automated solution for the measurement of dabigatran, a direct oral anticoagulant (DOAC). The assay, calibrators and controls are CE Marked.
With an extended linear range and very low limit of detection, the HemosIL DTI Assay with Dabigatran Calibrators and Controls provides unmatched technical performance for Hemostasis laboratories conducting dabigatran testing. This testing solution offers consistency and accuracy to help inform critical patient management decisions. Like other HemosIL assays, the DTI Assay is automated on the ACL TOP Family of Hemostasis Testing Systems for exceptional efficiency. Dabigatran etexilate (manufactured and marketed by Boehringer Ingelheim as Pradaxa®) inhibits the action of thrombin to provide an anticoagulant effect in vivo.
"With the growing use of DOACs around the world, the need to test for their presence and concentration has increased substantially," said Remo Tazzi, Director Worldwide Marketing, Hemostasis at IL. "The new DTI Assay addresses this critical need by providing an essential tool for patient management and epitomizes our responsiveness to customers and their dynamic healthcare environment."
HemosIL DTI is the first in a DOAC Assay Panel to be commercialized by IL. The Company plans to introduce assays, calibrators and controls for other DOACs in the coming months.
Although monitoring is not required for patients on DOAC therapy, there are exceptions when measurement may be beneficial. Examples include patients who: present to the ER with an adverse event; require immediate reversal of anticoagulation; experience renal or liver failure; have suspected or known interaction with other drugs; require verification of pre-operative drug clearance.
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