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Cardiac troponins help to diagnose nearly two-thirds of the patients in the diagnosis Acute Coronary Syndrome (ACS) who are missed out by Echocardiogram (ECG). ECG can detect only one-third of the patients with persistent ST-segment Elevation (STEMI), whereas cardiac troponins can distinguish patients without ST-segment elevation (NSTEACS; non-ST segment elevation ACS) who require a conservative Unstable Angina (UA) or early-invasive approach (NSTEMI).In addition to significant pricing challenges, there is growing competition encouraged by the adoption of point-of-care devices at physician offices and hospitals. Although technicians and patients prefer point-of-care devices, physicians and hospitals are still slow in adopting these devices due to conventional mindset and cost. High-sensitivity troponins are the latest addition to troponin tests and have expanded the clinical application. With the recent Food and Drug Administration (FDA) approval of a high-sensitivity troponin assay from Roche, it is soon expected that many more competitors will try to secure FDA approval that will further intensify the competition.In the US, troponin I and T faced a decline similar to other tests due to reimbursement cuts. However, the volume of tests used for troponin T has been increasing and will continue to do so for the next 5 years. Due to the implementation of the ACA, reimbursement cuts have resulted in increased pricing pressure on many of these lab tests. This is expected to continue for the next 5 years if the same systems are going to be used to reimburse tests. The Protecting Access to Medicare Act (PAMA) regulation is expected to impact the price of routine tests. This downward trend in pricing would impact manufacturers’ ability to be paid at the same rate for the cost of reagents.
The objective of this research is to establish an understanding of the market for cardiac biomarker Troponin used for the diagnosis of acute myocardial infarction. The research covers the revenue generated by the use of cardiac troponin tests for diagnosis of acute myocardial infarction.
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