On New Year's Day 2020, nobody could have guessed that the expertise of the life science research and diagnostics industry would soon become vital and that tests would become "one of the most important tools in the fight against the novel coronavirus" (Federal Ministry of Health).
Following the outbreak of the coronavirus in December 2019, researchers were able to identify and categorize the virus in a very short time. They are using technologies developed by life science research (LSR) companies. The virus genome is decoded using sequencing.
When the WHO declares the outbreak a pandemic in March 2020, laboratory diagnostics are in demand worldwide like never before. Testing options had to be developed quickly and testing capacities built up. Within a short time, the industry developed tests for the direct detection of the coronavirus and made them available in Germany. Enormous test capacities are built up in partnership with medical laboratories. At peak times, 1.5 million molecular tests (PCR tests) are carried out per week. Mobile, laboratory-independent PCR cartridge systems are now also available as an innovation for the rapid testing of patients, e.g. in hospital emergency departments. In addition, manufacturers offer antigen tests for use in central laboratories, which can also cushion temporary capacity bottlenecks in PCR testing at any time.
As the incidence of infection increases, the use of rapid tests is becoming increasingly important. The German government's testing strategy provides for their use where rapid results are important, where asymptomatic people are to be tested extensively and repeatedly. The protection of vulnerable groups, e.g. in care facilities and hospitals, including those working there, is the most important goal. The value contribution of in-vitro diagnostics is also immense for the resumption of regular school operations and the opening up of economic life. The diagnostics industry is providing millions of rapid antigen tests in particular to implement this political strategy.
In February 2021, the Federal Ministry of Health paved the way for the use of self-testing. The legislator expresses that self-testing plays an important role in containing the pandemic. They are a low-threshold and widely available tool for laypeople to quickly detect the coronavirus. This makes them an important addition to the national testing strategy. The industry also provides suitable products for the supply of this test category. Due to strict regulatory requirements, product approval is very complex here. Tests carried out by laypersons must not only prove their test quality, but also their suitability for use.
The emergence of various mutations of the coronavirus is a cause for concern at the beginning of 2021. The monitoring of this development is decided by law. Here, too, the industry immediately provides the necessary key, in particular sequencing technologies and typing PCR to differentiate between different virus variants in the laboratory.
With the start of COVID-19 vaccinations, the question of the body's immune response is becoming increasingly important. Antibody detection and test methods that make the cellular immune response measurable can provide crucial information here. However, compared to other healthcare systems, there is still a great deal of political reluctance in Germany towards these indirect detection methods. However, it is precisely the findings on the effect of vaccination on the vaccinee themselves and on others (infectivity) that are generated with such test procedures and that can show us ways out of the pandemic and into a new normality.
LSR products and diagnostics are also used in the research and development of vaccines and medicines. The variety of test technologies, the sensible coexistence of test applications by the medical laboratory, by trained personnel in healthcare facilities and by laypersons, as well as the innovative strength of small, medium-sized and large manufacturers - these are the key attributes that make up the LSR and diagnostics industry. We help patients and treating physicians. We can also lay the foundations for minimizing economic restrictions during the pandemic.