Early-diagnosis systems from Baden-Württemberg help prevent the spread of drug-resistant pathogens
More and more bacteria are developing resistance to multiple antimicrobial drugs. These multidrug-resistant bacteria can impede the action of common antibiotics via mutations or DNA transfer. More than 30,000 people are infected every year with multidrug-resistant bacteria in German hospitals alone. This could be prevented with appropriate hygiene measures and innovative test systems. Innovative test systems that enable reliable and rapid diagnoses have been developed in Baden-Württemberg, which is home to many research institutions and research-based medical companies.
Even though Baden-Württemberg has had significantly fewer cases of MRSA than any other German state1, there is no reason to sit back and relax. MRSA bacteria, i.e. methicillin-resistant Staphyloccus aureus species that have developed resistance to beta-lactam antibiotics, are the most common and best-known representatives of antibiotic-resistant bacteria. The number of infections with tuberculosis bacteria, which are becoming increasingly resistant to antibiotics, is also increasing in Baden-Württemberg.2 If existing antibiotics are no longer effective and reserve antibiotics also fail, even mild infections and once eradicated diseases can become very dangerous. It is especially easy for bacteria to spread in places where there are large numbers of people, for example in highly frequented public toilets in airports3, and in particular in hospitals where people with severe infections or other diseases are treated. Immunocompromised patients are at a particular risk of infection. In addition to effective hygienic measures, early diagnosis can help prevent the transmission of the bacteria.
Diagnosis – a rapid method of pathogen detection is crucial
Hospitals and doctors usually send their patient samples to specialised diagnostic laboratories for analysis. Depending on the test method used, it can take several days before results are returned. Highly infectious pathogens can spread quickly as, logistically, it is impossible to isolate patients for the time it takes to analyse the sample and detect the pathogen. A rapid method of pathogen detection is therefore crucial so that appropriate therapy can be initiated and the spread of bacteria in hospitals prevented, thus helping to reduce the risk of resistance formation. A company called Hain Lifescience GmbH from Baden-Württemberg has developed modern test systems for detecting tuberculosis and other pathogens that help reduce the time it takes to obtain a result to a few hours.
Pathogens can now be diagnosed in hospitals and even emergency wards thanks to easy-to-use, fully automated systems. Highly specialised pathogen-specific diagnostic tools that deliver reliable results relatively quickly have now become available, thus enabling rapid isolation and effective therapy. SpinDiag GmbH, a start-up company from Freiburg, manufactures systems that enable doctors to detect drug-resistant bacteria directly from patient samples. The SpinDiag test can screen patients for the 25 most common antibiotic resistances upon admission to hospital. Infected patients can therefore be isolated immediately and the spread of the bacteria prevented.
Curetis GmbH from Holzgerlingen has developed a platform that uses different cartridges to identify various pathogens and antibiotic resistance markers for the simple and rapid identification of severe infections such as pneumonia, implant, tissue and blood infections.
New therapies are urgently required
Baden-Württemberg lies somewhere in the middle of all German states in terms of antibiotics prescription volumes. The Saarland has the unenviable record as the state with the highest volumes.4 Multidrug-resistant organisms (MRO) are a particular challenge because the enormous quantity of antibiotics taken over past decades has accelerated resistance development. Reserve antibiotics, i.e. antibiotics that are only used for destroying drug-resistant bacteria, are in many cases the last option. However, quite a few bacterial species have already developed mechanisms to deflect the action of reserve antibiotics too.
Medical researchers are under huge pressure to come up with new therapeutic options so that we will not be left without effective antibiotics in the near future. Identifying suitable drugs is far from easy. Substances that kill bacteria are available, but they are usually also harmful to patients. However, 88 years after the accidental discovery of penicillin, the German Centre for Infection Research (DZIF) at the University of Tübingen has had another stroke of luck in antibiotic research. The DZIF researchers have discovered that a bacterium in the human nose produces a previously unknown antibiotic compound that can destroy multidrug-resistant bacteria. The researchers’ results were published in the scientific journal Nature in July 2016.5 “Antibiotics are one of the most important inventions in medicine and we all need to use them responsibly in order to maintain their effectiveness and stop it becoming impossible to treat life-threatening infections at some point in the future. We are proud supporters of the small, medium and large companies in Baden-Württemberg that are developing diagnostic tools and medicines to counteract bacterial resistance as effectively as possible,” says Prof. Dr. Ralf Kindervater, CEO of BIOPRO Baden-Württemberg GmbH.
Hain Lifescience GmbH is headquartered in Nehren in the administrative district of Tübingen, and was founded by David and Tobias Hain around thirty years ago. The company has 180 staff worldwide. More than sixty percent of the employees work in the company’s headquarters in Nehren. This family company run by the Hain brothers manufactures and distributes in-vitro diagnostics devices “made in Germany” to medical laboratories worldwide, and also creates the basic conditions for modern laboratory diagnostics in developing countries and emerging economies. The company’s genetic test systems can be used, amongst other things, for diagnosing risk factors for human genetic diseases, and for detecting dangerous pathogens such as tuberculosis bacteria and antimicrobial resistances.
The emergence of extensively drug-resistant tuberculosis strains presents an increasing global public health threat. The company’s strip tests quickly and reliably analyse antibiotic resistance. They reduce the time to result from several weeks or months to a few hours, so effective therapy can be initiated as early as possible. The World Health Organisation (WHO) has already issued a number of Hain Lifescience product recommendations; the most recent recommendation was issued in May 2016 for the company’s rapid GenoType MTBDRsl tuberculosis test.
SpinDiag GmbH was spun out from Hahn-Schickard, one of the leading microsystems engineering research institutes, in 2016 with the mission to develop a system for rapidly detecting antibiotic-resistant pathogens. In 2015, the company’s founding team won first place for its business model in the Startinsland competition under the category “Innovation from Science and Universities”. In 2016, SpinDiag achieved 4th place in the Science4Life Venture Cup, a business plan competition for innovative start-up companies. The team also won the CODE_n new.New Festival HealthTech Cluster Award and one of the three Health-I awards sponsored by the Handelsblatt and the Techniker Krankenkasse.
The company’s team of researchers have developed the SpinDiag one system which enables fully automated PCR-based screening for drug-resistant pathogens in less than 30 minutes from swab samples. Up to 25 parameters can be simultaneously detected, making it possible to reliably detect antibiotic-resistant bacteria when patients are admitted to hospital. Infected patients can thus be isolated immediately, effective therapy initiated and the risk of infecting other patients and staff reduced.
It usually takes several days to obtain the results of a common antibiogram for determining the antibiotic resistance of bacteria. Curetis GmbH was founded in 2007 by a team of six engineers, medical doctors and biologists with the aim of developing a method that provides doctors and patients with rapid results and the possibility of initiating early therapy. The Unyvero platform has been available since 2012, is the same shape and size as a multifunctional printer and can be used with various cartridges. The devices carry out all steps from sample preparation to sample analysis automatically. Different cartridges are used to easily and rapidly diagnose severe infectious diseases in no more than four to five hours. The system can be used in hospital laboratories as well as directly in intensive care wards.
Three Unyvero cartridges are currently available, one for detecting pneumonia, one for analysing implant/tissue infections and one for analysing blood cultures. Hospitals with large intensive care units are among the company’s major clients. More than 120 Unyvero systems are currently being used in places like the University Hospital of Tübingen. Curetis employs more than 80 people and has raised 44.3 million euros in an IPO on Euronext Amsterdam and Euronext Brussels, and private equity funds of over 63.5 million euros. The company has signed collaboration agreements with Heraeus Medical and Cempra Inc. as well as several international distribution agreements in many countries in Europe, the Middle East and Asia. Curetis has just submitted a 510(k) application to the FDA for its Unyvero platform.
BIOPRO Baden-Württemberg GmbH:
BIOPRO Baden-Württemberg GmbH supports the Baden-Württemberg healthcare industry, including the medical technology, diagnostics, biotechnology and pharmaceutical industry sectors, and the development of a bioeconomy. BIOPRO is the central point of contact for companies, research institutes, networks and people who intend to establish a company. BIOPRO’s aim is to support technology transfer, promote innovation and create impulses for Baden-Württemberg as an attractive research and development location. We also provide the healthcare industry and the general public with comprehensive information on the latest research and development trends in Baden-Württemberg.