Roche Diagnostics: A proud history at the front-line in the war against heart attacks

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The Troponin T test, developed by Roche Diagnostics, has revolutionized the management of heart attacks, the world’s most deadly disease.  Today the test is used in millions of patients worldwide every year, saving thousands of lives by enabling doctors to detect and act on heart attacks earlier than before. It all started more than 25 years ago, with a perfect match between academic research and industrial development.

Over 25 years ago, the development of the Troponin T test started a revolution in the management of heart attacks, also called myocardial infarction (MI), the world’s number one killer. Since then, Troponin testing has become the cornerstone of MI diagnosis and Roche Diagnostics been leading the evolution of this critical marker every step of the way. Roche has always been committed to finding innovative solutions in healthcare and cardiology is an area of testing where Roche Diagnostics has a particularly proud and rich history. Today, Troponin T is the most widely used and most extensively researched and validated test available for diagnosing MI. 

Before 1980, there were no comparable markers or tests available and myocardial infarctions were diagnosed on the basis of enzyme levels, such as creatine kinase. These methods were imprecise and not particularly sensitive.  Thus there was a clear clinical need to develop something new. This is when the close partnership between Roche and Professor Hugo A. Katus, Head of Cardiology, Angiology and Pulmonology at Heidelberg University, began to form.  

Professor Katus identified the potential for Troponin T in diagnosing heart attacks, but needed a technology partner to develop an assay capable of measuring it. This paved the way for the Roche research and development team, in Mannheim, to create an innovative testing solution. It was only  the advent of the completely new technology of immunoassays which provided a way to develop new diagnostic approaches. Using antibodies, it was possible to measure protein molecules that had no enzyme activity, for the first time.  The immunoassays had the additional benefit to be high highly sensitive. Both these properties were essential for developing a biomarker test, such as Troponin T, for successful use in clinical diagnosis. 

Professor Katus stated of the collaboration “The company's expertise in assay development was particularly important. Roche also possessed the infrastructure needed to perfect a test of this type and develop it into a product that was reliable and delivered reproducible results. For our part, we provided the concept, an understanding of the clinical issues and needs and medical expertise. It proved to be a perfect match and ultimately resulted in a test that has had a huge impact on clinical practice. Suddenly we were able to predict risks much more precisely and also detect many more infarctions, even microinfarctions.”

In this respect, the discovery of Troponin T represented a genuine paradigm shift and this led to the commercial launch of the first Troponin T immunoassay test, the ELIZA Troponin T in 1989. However, the evolution of the Troponin T test did not stop with the first version of the immunoassay.  Continuous improvements and modifications have been made, over the years with new generations being released in 1993, 1996, 2005, until the  world’s first high sensitive Troponin T assay was released by Roche in 2009, as the 5th generation, in Europe (and cleared in the USA, in 2017, as the first high-sensitive troponin test). In the beginning Troponin T was only used to diagnose myocardial infarctions, though over the years and with increased test sensitivity, the range of clinical uses applications has expanded, with a wealth of clinical data to support its use, in areas such as risk stratification and prognosis of cardiac diseases 

With each new generation Roche has refined and enhanced the sensitivity, accuracy and precision to such a high level that it is now possible to accelerate the diagnosis of acute myocardial infarctions (AMI) with a one-hour protocol using the 5th generation Troponin T test. This reduces the observation time needed to rule-in or rule-out a heart attack in most patients from 3-6 hours. In other words, high sensitivity troponin T, invented by Roche, is saving not only minutes but several hours for patients with this time-critical and life-threatening condition. This is especially important since time delay from the onset of symptoms to treatment increases the risk of death.

“Troponin T high sensitive is the most widely used troponin test in the world, taken in millions of patients MI every year. Based on what we know about the impact of time on survival and the time-saving made possible by high sensitivity Toponin T, this test is saving tens of thousands of lives around the world every year” says Mathias Egermark, MD International Business Leader for Cardiology at Roche Diagnostics.

As healthcare professionals learn more about MIs, Roche will continue to search for innovative ways to help physicians and their patients to achieve even better outcomes. 

About Myocardial Infarctions

MI is a frequent cardiac disorder particularly in elderly people and may be a manifestation of a coronary artery disease. Annually, more than 7 million people worldwide die from a heart attack, as 1.8 million deaths per year occur from cardiovascular disease in Europe alone. MI displays to a physician in a wide variety of indications, from no symptoms to severe chest pain which typically radiates into the patient’s jaw, back, or in one or both of his arms. Pain results from a cardiac perfusion imbalance between blood supply and demand, frequently caused by an occluded coronary artery with a blood clot following rupture of an atherosclerotic plaque. Signs and symptoms include chest pain, breathlessness, dyspnea, fainting, hypotension, light-headedness and sweating. 

Cardiac biomarkers support health care professional decision making when faced with an emergency situation of a heart attack. First results from an ECG check can indicate MI. However, not all MIs can be diagnosed using ECG. To aid in the diagnosis and improve risk stratification, a cardiac biomarker, such as a Troponin test supports a physician in early induction of the appropriate therapeutic management. 

Myocardial infarction can be detected by elevations in cardiac troponin in the blood. Cardiac troponins are the preferred markers of myocardial infarction. The Elecsys® cardiac troponin T high sensitive test enables cardiologists to diagnose or exclude myocardial infarction at much lower Troponin T levels compared to previous cardiac troponin test generations and helps to detect AMIs earlier. The test complies with the latest recommendations of the European Society of Cardiology (ESC) and American College of Cardiology (ACC). 

Early steps for preventive action may help to avoid an increased risk of heart disease. A change of personal lifestyle is a major modifiable criterion to prevent cardiovascular diseases. For example, low fat and carbohydrate diet as well physical exercise support a personal health situation and well-being.

How can you diagnose heart attack?

The diagnosis of heart attack is based on three elements:

  • the clinical symptoms (e.g., chest pain history)
  • the results from the electrocardiogram (ECG)
  • and the results from a biomarker, preferentially cardiac troponin blood test. 

The presence of an elevated segment on the ECG recording is one of the possible indicators of AMI. Emergency room terminology describes this as ST elevation myocardial infarction (STEMI). However, in over 50% of AMI cases, the ECG fails to detect heart attack which is known as non-ST elevation myocardial infarction (NSTEMI). 

In the case of inconclusive ECG, cardiac biomarkers such as troponin are crucial for the diagnosis of heart attack which is supported by clinical guidelines requiring that the event cannot be considered as an acute myocardial infarction unless there is a rise and/or fall in the troponin levels.

References:
1. http://www.who.int/gho/mortality_burden_disease/en/ and http://www.who.int/mediacentre/factsheets/fs310/en/
2. De Luca G et al Time delay to treatment and mortality in primary angioplasty for acute myocardial infarction: every minute of delay counts.Circulation (2004) ; 109, 1223-5.
3. White HD and Chew DP. Acute Myocardial Infarction. Lancet (2008) 372:570-54.
4. Wilkins E, et al. European Cardiovascular Disease Statistics (2017). European Heart Network, Brussels.
5. Braunwald E. Unstable angina and non-ST elevation myocardial infarction. Am J Respir Crit Care Med. (2012) ;185(9):924-32.