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Milestone Laboratory Diagnostics Laboratory diagnostics – crucial foundation for advances in medical science

Author / Editor: Dr. Ilka Ottleben* / Dr. Ilka Ottleben

Much better treatment options now exist for many illnesses compared to what was available ten years ago. Their effectiveness depends, however, on early detection. Laboratory diagnostics create a highly dynamic bond between scientific progress and medical applications.

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Fig. 1 Roche Diagnostics: Innovative by tradition
Fig. 1 Roche Diagnostics: Innovative by tradition
(Picture: © F. Hoffmann-La Roche Ltd)

Many years of stress, poor nutrition, a sedentary lifestyle and occasional chest discomfort – but nothing to really worry about. Then suddenly, there is a medical emergency. Acute chest pain, a squeezing sensation, shortness of breath ...

49,210 men and women died of heart attack in 2015 according to figures released by the German Federal Statistics Bureau. Acute myocardial infarction is the second highest cause of death in Germany. Heart attack was diagnosed 219,217 times that year across the nation, but a closer look at the figures reveals a drastic decrease in the mortality rate in recent years. According to the German Cardiac Association (DGK), the mortality rate resulting from acute heart attack stood at 59.3 per 100,000 population in 2014. This represents a decline of roughly 45% compared to 1990.

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Despite the danger and sometimes the tragedy which a heart attack causes the individual patient, this is an impressive example of the enormous progress which has been made in recent years in many fields of medicine. Improved therapy options obviously play a crucial role along with structural improvements in health care delivery. However, early detection is absolutely vital. Normally the earlier the treatment of heart attack, cancer or diabetes begins, the better. Diagnostics lay the groundwork for effective therapy.

The name of the company, which has played an important role in the successful development of medical diagnostics in recent years, includes the word "Diagnostics". The firm was founded in 1896 as F. Hoffmann-La Roche & Co., and expanded into a new business sector in 1968 when it set up the diagnostic products unit. In addition to work on new, sensitive diagnostic tests, the development of automatic analysis equipment was also a priority right from the start. In 1978, the diagnostics business introduced the first Roche in vitro analyzer, the Ccobas Bio. That was just the first of many milestones. The trade name cCobas is now synonymous with efficiency, accuracy and reliability. Through the acquisition of Boehringer Mannheim in 1998, Roche became the world market leader in the diagnostics sector.

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LP-Tip –  Roche Germany

Roche has roughly 15,900 employees in Germany working in pharmaceuticals and diagnostics. The large operating subsidiaries are located in Grenzach-Wyhlen (Roche Pharma AG), Mannheim (Roche Diagnostics GmbH, Roche Diagnostics Deutschland GmbH, Roche Diabetes Care GmbH and Roche Diabetes Care Deutschland GmbH) and Penzberg (Biotechnologie-Kompetenzzentrum, Roche Diagnostics GmbH).

When every minute counts

The spectrum of measurable, illness-related parameters continues to expand. In the field of heart attack diagnostics, measurement of cardiac troponins as a highly sensitive marker for cardiac events led to the breakthrough. This specific protein complex in the myocardium is released when damage to the heart muscle occurs. Measurement of the troponin T level provides the basis for faster and more reliable diagnostics. For example even in cases where changes, which are typically present when a heart attack occurs, are not evident in the ECG. DGK (Deutsche Gesellschaft für Kardiologie – Herz- und Kreislaufforschung e.V.; German Cardiac Society) President Prof. Hugo A. Katus originally discovered troponin T and developed the measurement technique together with Boehringer Mannheim and subsequently with Roche Diagnostics. The test is now regarded as the gold standard in heart attack diagnostics. The results of the TRAPID-AMI [1] clinical study published in 2016 confirmed that the Roche Elecsys Troponin T high sensitive test (hs-cTnT) reduced the observation time needed to diagnose, or rule out, heart attack in patients presenting with acute chest pain from three or more hours to one hour. Given the fact that a 30 minute delay in the onset of treatment increases the relative mortality rate by 7.5% [2], the time reduction is enormously valuable and can save lives.

How ECL became the market leader

Electrogenerated chemiluminescence (ECL) introduced by Roche in 1996 on the Elecsys System created the basis for this and other tests in the portfolio. Right from market introduction, ECL set new standards in precision, speed and sensitivity. Today, the technology offers a level of sensitivity which is truly amazing when you consider the following example. The world population currently stands at around 7.5 billion. If one of these persons were to wear a blue hat, ECL would be capable of identifying that person

in only 18 minutes. ECL is an immunological technique, and assays are normally based on antigen-antibody reactions in sandwich assay format. The measurement is based on an electrochemical reaction with very low detection thresholds over a large measurement range.

At market introduction, 16 tests could be run on the Elecsys System, primarily for thyroid diagnostics and tumor markers. The range of tests quickly expanded to include. tests for diagnosis of cardiovascular disease such as troponin T, for infectious diseases and the determination of hormones. By 2000, 51 Elecsys tests were available on the market. Electrogenerated chemiluminescence currently provides the technological basis for all heterogeneous Elecsys immunoassays and the Cobas e-modules. The parameter portfolio now includes 105 tests. Test development continues in parallel with system development. Roche has a three-track strategy. Track 1 is consolidation of the range of markers for a particular indication. Track 2 is determined by newly discovered parameters for specific indications such as NT-proBNP for heart insufficiency. The third track is aimed at stratification and also includes tests as companion diagnostics approved for a particular medication, e.g. determination of the anti-Müllerian hormone (AMH) to determine the correct doses of a pharmaceutical product used in fertility treatment.