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FDA Clears Siemens Healthineers High-Sensitivity Troponin Test for Heart Attacks

NEW YORK (360Dx) – Siemens Healthineers today said that the US Food and Drug Administration has cleared its high-sensitivity troponin I assays for use on its Atellica IM and Advia Centaur XP/XPT immunoassay analyzers to aid in the early diagnosis of myocardial infarctions, or heart attacks.

Siemens said that the high sensitivity of its two TnIH assays offers the ability to detect lower levels of troponin than previous generation assays and to detect smaller changes in a patient’s troponin level as repeat testing occurs. As a result, clinicians can have greater confidence in the results and begin treatment, the firm said.

The firm's high-sensitivity Advia Centaur troponin I assay had received CE marking in May and was the subject of a recent study published in Clinical Chemistry, which noted that it is comparable to that of established high-sensitivity troponin assays developed by Abbott and Roche.

Highly sensitive troponin T and I tests have been clinically available in Europe and other countries outside the US since 2010, including tests from Singulex and Beckman Coulter in addition to Roche and Abbott. In January 2017, the FDA cleared Roche's next generation troponin test, making it the first high-sensitivity troponin test available in the US for use as an aid in diagnosing myocardial infarction.

In June this year, the FDA also cleared the Beckman Coulter Diagnostics high-sensitivity troponin assay, the Access hsTnI, for use on the Access family of immunoassay systems.

When blood flowing to the heart is blocked, the heart muscle begins to die in as few as 30 to 60 minutes and releases troponin into the bloodstream. Siemens noted that with data to properly triage patients sooner or to exclude myocardial infarctions, its FDA-cleared TnIH assays can help support testing initiatives tied to improving patient experience.

Chest pain is the cause of more than 8 million visits annually nationwide to emergency departments, but only 5.5 percent of those visits lead to serious diagnoses, such as heart attacks.

Jim Freeman, vice president of R&D laboratory diagnostics at Siemens Healthineers, said that the total cost of unnecessary admissions and misdiagnosis of heart attacks reaches billions of dollars each year. About 90 percent of patients with chest pain are not having a heart attack, and 2 percent to 8 percent of heart attacks are critically missed, he said. "This stresses resources and leads to unnecessary and costly admissions along with poor patient outcomes," Freeman said.

The ability to diagnose acute myocardial infarction earlier helps to improve the standard of care for patients experiencing heart attacks. It can also reduce emergency room crowding and improve the standard of care for patients with other emergencies, Freeman said. "The increased precision of the Siemens Healthineers High-Sensitivity Troponin I assay may help lower the potential of missed diagnoses, which would help to reduce costly readmissions of patients who return later with AMIs and must be readmitted,” he said.

Alan Wu, chief of clinical chemistry and toxicology at Zuckerberg San Francisco General Hospital and Trauma Center, said in a statement that high-sensitivity troponin testing leading to more efficient triaging of patients in an overcrowded emergency department will enable discharging patients who do not need to stay, and that "will have a tremendous economic advantage for our healthcare system."

The TnIH assays also meet the latest industry guidelines, which are evolving, Siemens said.