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Quidel Receives CE Mark for TriageTrueTM High Sensitivity Troponin I Test, Its Next-Generation Diagnostic Assay for Aid in Diagnosis of Myocardial Infarction for Use with Quidel’s Triage® MeterPro Instrumented System

Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has received CE Mark for its TriageTrueTM High Sensitivity Troponin I Test for the quantitative determination of troponin I in EDTA anticoagulated whole blood and plasma specimens. The test is to be used as an aid in the diagnosis of myocardial infarction (MI) for use with Quidel’s Triage® MeterPro instrumented system.

MI, or heart attack, occurs when a part of the heart muscle doesn’t receive enough blood flow. The more time that passes without treatment to restore blood flow, the greater the damage to the heart muscle. According to the World Health Organization (WHO), it is estimated that almost 18 million people die each year from cardiovascular diseases (CVD), and 85% of allCVD deaths are due to heart attacks and strokes.1

Troponin I, T and C are protein subunits that make up the troponin complex, which is integral to the regulation of myofibril contraction in skeletal and cardiac muscle cells. Cardiac troponin I assays are commonly used as aids in the diagnosis of MI which is injury to cardiac muscle cells caused by ischemia. When an MI occurs, cardiac troponin I levels rise after the onset of cardiac symptoms, reaching a peak at 12 to 16 hours and can remain elevated for 4 to 9 days. Upon patient presentation, the determination of presence and concentration of troponin levels through serial monitoring at different time points can help diagnose MI and differentiate it from other cardiovascular and non-cardiovascular conditions.

The latest generation of troponin assays can detect and quantitate troponin at lower levels than previous generation assays, giving them higher sensitivity for the detection of MI at the time of patient presentation. This advancement allows for the time interval between baseline measurement and the second measurement of cardiac troponin to be significantly shortened, thereby reducing the time to diagnosis and improving efficiency in the emergency department.

The TriageTrueTM High Sensitivity Troponin I Test is a single-use fluorescence immunoassay device for use with Quidel’s Triage® MeterPro instrument and designed to determine the concentration of troponin I in whole blood or plasma specimens, anticoagulated with EDTA. TriageTrueTM features a redesigned cartridge that greatly improves assay sensitivity and precision which are critical to the performance of high sensitivity troponin testing. The assay uses monoclonal antibodies specific to human cardiac troponin I in the detection and quantitation of cardiac troponin I. The results are displayed on the MeterPro screen in <20 minutes from the addition of specimen to the device. All results are stored in the MeterPro memory to display or print when needed. Also, the integrated cartridge design enables a lower total cost per reportable result than standard immunochemistry analyzers in low volume settings. When connected, the MeterPro can transmit results to the laboratory or hospital information system. TriageTrueTM enables hsTnI testing to be performed in the emergency department, urgent care facilities and other decentralized settings.

“We are very pleased to receive the CE Mark for our next-generation Troponin I assay. This accomplishment is truly a team effort, and really speaks to the success of our integration of our Triage team at Summers Ridge,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “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.”


About Quidel Corporation

Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel's recently acquired Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio, visit

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Last Updated: 29-Nov-2018