Infections with antibiotic-resistant bacteria and diseases such as breast or colon cancer are among the major causes of death worldwide. Early diagnosis is therefore key for the identification of people affected and for providing immediate therapy. The R&D service provider Hahn-Schickard and its partners are currently working on the development of a rapid and simple diagnostic system that can detect life-threatening infections and cancer at an early stage.
Multidrug-resistant bacteria pose a great challenge for healthcare professionals worldwide. There are two major reasons for this. Firstly, the number of deaths caused by bacterial infections that cannot be treated is high. Secondly, antimicrobial resistance makes effective management and medical treatment of infections caused by bacteria and other pathogens difficult. In addition, it is important to isolate infected patients in hospitals in order to prevent others from becoming infected. Therefore, identifying people infected with multidrug-resistant bacteria before they come into contact with other patients is crucial. In addition, a large number of people die from breast or colon cancer, not least because the disease is diagnosed when the cancer is already at an advanced stage and the chances of successful treatment are low. The project FasterPCR (Fast automated diagnostic system targeting severe resistant pathogens and cancer, EuroTransBio) is therefore aimed at developing an automated point-of-care system that facilitates non-invasive testing for the presence of breast and colon cancer DNA and multidrug-resistant bacteria in the body. The device's ability to identify both cancer and bacterial DNA underscores the project’s platform approach and demonstrates the broad applicability of the technology.
Point-of-care systems are mobile diagnostic devices that can be used to perform medical tests at the bedside, i.e. in hospital wards or GP surgeries, without needing to send samples to a central laboratory and wasting valuable time. Point-of-care devices and tests are designed to be easy for medical staff to operate without comprehensive training and to provide reliable results within a short time.
“Hahn-Schickard has been involved in the research and development of automated diagnostic systems for many years,” says Ingmar Schwarz who is in charge of developing the disposable LabDisk cartridge. The FasterPCR project’s planned point-of-care system will consist of two components, a test carrier and a processing device. The LabDisk is designed as a disposable cartridge and will contain all the necessary test reagents. A company called E.L.T. Werkzeugbau GmbH, which specialises in injection-compression moulding processes, is in charge of developing the cartridge mould. Hahn-Schickard will fill the cartridge with reagents and finalise the manufacturing process.
A blood sample from a patient is applied to the disk-shaped microfluidic LabDisk, which is then inserted into a special processing device that automatically analyses it for the presence of pathogens and cancer. The goal is to have the results ready in less than 45 minutes so that treatment can be initiated without delay. “We believe that the comprehensive analysis of a sample from a patient directly on site in the hospital ward or GP's surgery is unique. What is particularly special about this system is the speed with which the analysis is performed,” said Schwarz. In addition, the patient sample is safely stored in the LabDisk, which can be safely thrown away in its entirety once the analysis is complete.
As the disposable cartridge will be produced in large quantities, it will not contain any active electronic or optical elements. All active components needed to perform the analyses are integrated into the processing device, including a controllable motor for rotating the LabDisk, rapid temperature control and sensitive optical elements for fluorescence-based detection of the reaction. “The device software automatically controls all the components and provides the user with the diagnostic results,” said Schwarz. The point-of-care device is being developed at the Fraunhofer Institute for Physical Measurement Techniques in Freiburg (IPM).
Sample analysis involves amplifying the bacteria's genetic material, and, in this case, the bacteria's resistance-conferring fragments. “We use modified real-time PCR (polymerase chain reaction), which only requires a small amount of sample. In addition, the sample does not need extensive pretreatment,” says Schwarz pointing out that the method reduces the number of process steps as well as making the test simpler, faster and cheaper. PCR-based nucleic acid analysis can be used to determine whether a patient is infected with multidrug-resistant bacteria or has breast or colon cancer. A company called altona Diagnostics GmbH is in charge of developing the assays that enable detection of the pathogens and their resistances. Meanwhile, a Spanish start-up called StemTek Therapeutics is developing an assay system that enables early diagnosis of breast and colon cancer. The cancer test is based on 15 different gene sequences.
"Our project aims to demonstrate that the system can be used at the point of care, and that users need not undergo comprehensive training,” said Schwarz describing the advantages of LabDisk. Sample preparation is easy and quick. The analytical device does all the work and all the user needs to do is wait for the results. The point-of-care device has clear benefits for patients who do not have to wait for the results and enables treatment to commence immediately. Doctors also benefit from the device, as it optimises their workflow. “We provide doctors with the much-needed ability to clarify an issue quickly,” said Schwarz. The LabDisk system can be used for a broad range of applications. Doctors can tell within 45 minutes or so of a patient's admission whether the patient is carrying antibiotic-resistant bacteria and can then take appropriate action. In addition, the system enables early detection of cancer as well as therapy monitoring, which is a key success factor in permanent cure. Therapy can be closely monitored and doctors can intervene quickly to adapt the therapy if required.
The FasterPCR project is planned to run for three and a half years. It has now been running for slightly over a year. “We and our project partners are therefore right in the middle of the research and development phase,” said Schwarz from the Fraunhofer IPM where a prototype of the device and a concept for serial production are being developed. An Italian company called DATAMED srl will eventually turn the prototype into a production-ready device. However, at present, the LabDisk needs to be optimised further in order to guarantee trouble-free process flow. In addition, the two assay producers are working on assays for the detection of resistant bacteria and cancer. At the end of the project, the partners hope to have a functional diagnostic system consisting of assays, single-use cartridge and a processing device.