Quidel Gets CE Mark for Near-Patient High-Sensitivity Troponin Test

NEW YORK (360Dx) – Quidel announced today it has received CE marking for a near-patient diagnostic assay for determining troponin I levels as an aid in diagnosing myocardial infarction.

The TriageTrue High Sensitivity Troponin I Test is a single-use fluorescence immunoassay that detects a subunit of the troponin complex released by heart muscle cells after a myocardial infarction. The test is run using whole blood or plasma specimens that have been anticoagulated with EDTA on the Quidel Triage Meter Pro instrument.

Quidel acquired the Triage assets last year when Alere divested them as part of that firm's acquisition by Abbott. The near-patient immunoassay system displays results in less than 20 minutes, as well as stores and transmits results to the laboratory or hospital information system. The integrated cartridge also allows for a lower total cost per result than standard immunochemistry analyzers in low volume settings, the firm said in a statement. 

Serial monitoring of troponin concentrations over time can distinguish a heart attack from non-cardiovascular conditions. Quidel noted that high-sensitivity troponin assays can detect and quantitate troponin at lower levels than previous generation assays, reducing the interval required between the baseline and second measurements.

"We are proud to introduce the world's first near-patient high-sensitivity diagnostic test for Troponin I, and are excited by the positive impact that we can make in accurately providing results in 20 minutes or less to aid in diagnosing a heart attack," said Douglas Bryant, president and CEO of Quidel.

A handful of other firms have recently received regulatory approvals for high-sensitivity troponin I assays that run on lab-based instruments. A test on the Abbott Architect system was CE marked in September, while Roche received US Food and Drug Administration clearance for its nine-minute Elecsys Troponin T Gen 5 Stat blood test in early 2017. High-sensitivity troponin I assays from Beckman Coulter and Siemens received FDA clearance in June of this year. Abbott also has a point-of-care troponin test on the iStat system in development that a recent study showed compared favorably to lab-based test results.