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Ortho Clinical Diagnostics Receives Health Canada Approval for High Sensitivity Troponin I Assay

NEW YORK – Ortho Clinical Diagnostics on Thursday announced that Health Canada has approved its next-generation Vitros High Sensitivity Troponin I assay, a critical tool for clinicians seeking improved strategies to more rapidly and accurately identify patients suffering from a heart attack. The firm said it is launching the assay in Canada.

The latest addition to Ortho's cardiology menu, the assay also aids in identifying low-risk patients who may be safely discharged to help reduce the cost of care and alleviate the burden on hospital resources, the firm said.

Heidi Casaletto, head of portfolio strategy and marketing at Ortho, said that the assay's "improved analytical performance complies with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) definition of high sensitivity, enabling use with rapid rule-in/rule-out diagnostic protocols and allowing hospitals to more quickly diagnose and treat patients."

The Vitros High Sensitivity Troponin I assay can run on Ortho's latest analyzer, the Vitros XT 7600 Integrated System, and on the Vitros ECi/ECiQ Immunodiagnostic Systems, the Vitros 3600 Immunodiagnostic System, and the Vitros 5600 Integrated System.