FDA approves a new generation of myocardial infarction blood test

Release date: 2017-02-06

Recently, Roche announced that its new blood test, Elecsys troponin T Gen5 STAT (TnT Gen5 STAT), was approved for FDA approval. This is the first new generation of troponin-based in vitro test approved in the United States to help doctors diagnose patients with myocardial infarction more accurately.

Myocardial infarction is one of the most common and frequent acute heart disease, and in the United States, an average of every 43 seconds occurs. For patients with myocardial infarction, every second is crucial. The sooner the diagnosis is made, the sooner you can start treatment, and the chance of cure is greater. For the emergency room in the United States, about 8 million cases of myocardial infarction with chest tightness and shortness of breath are received each year, but only about 5-20% of them are true myocardial infarction. Correct diagnosis and appropriate treatment as soon as possible can also help the hospital allocate resources reasonably and effectively.

â–²TnT Gen5 STAT test (Source: cobas)

Myocardial infarction refers to the blockage of the coronary artery that supplies blood to the heart, causing ischemia and hypoxia in parts of the heart, leading to death of cardiomyocytes. The longer the blood supply is interrupted, the more the cardiomyocytes die and the more impaired cardiac function. When cardiomyocytes die, they release troponin into the bloodstream. Therefore, if troponin can be detected in the blood, it can be used as a standard for diagnosing myocardial infarction.

This new generation of troponin, developed by Roche, has a high sensitivity to detect very low concentrations of troponin in the blood, which can diagnose even small-scale myocardial infarctions. More importantly, this test is fast, and it takes only 9 minutes to complete the test, which can earn valuable time for diagnosis and treatment.

â–² mechanism of myocardial infarction (Source: medgadget)

This new generation of tests has been used in many other countries around the world for the past seven years and has been widely welcomed by hospitals and doctors. Its accuracy and effectiveness are supported by more than 600 peer-reviewed papers.

Dr. Frank Peacock, MD, of the Baylor Medical Center in Houston, USA, said: "As an emergency room doctor who faces many chest pain patients every day, my rapid and safe diagnosis relies on the sensitivity of the troponin test. FDA approves Roche's The new generation of TnT testing is the best news for patients with chest pain in the past decade."

We hope that this test will be widely used as soon as possible to save more lives of patients with myocardial infarction.

Reference material

[1] Roche (RHHBY)'s Heart Attack Testing Technology Gets OK From the FDA

[2] Roche's official website

Source: WuXi PharmaTech (Wei Signal WuXiAppTecChina)

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