Second diagnostic panel in the PCR | ONE system

The Polish biotechnology company Curiosity Diagnostics, belonging to the Scope Fluidics company, listed on the NewConnect, has achieved another milestone in the PCR | ONE project. It has developed a laboratory version of the microfluidic chip for the Clostridium panel, together with the methods and reagents for detecting Clostridium difficile. This is the second panel developed by the Company, after MRSA (identification and antibiotic resistance of Staphylococcus aureus).

The company from the Scope Fluidics capital group has completed the next stage of works in the PCR | ONE project. The effect is the development of an integrated microfluidic chip, biochemical methods and reagents to be applied in detecting Clostridium difficile and determining its virulence. The function of the panel is a rapid detection of the bacterium and an analysis of the presence of genes responsible for the production of various dangerous toxins that can lead to a severe form of colitis, which could be fatal, especially among the elderly. The Clostridium panel used in the PCR | ONE system analyzes the patient’s stool sample in order to obtain decisive information about the Clostridium difficile infection and the level of risk it poses. The effectiveness of the newly developed method has been confirmed in many laboratory tests in which the assumed parameters were achieved.

“This is the second panel that we have developed, aimed at detecting bacterial pathogens responsible for the most common and most serious infections acquired by patients in hospital settings. The Clostridium panel used in the PCR | ONE system is to help the fastest and most complete diagnosis of the pathogen. Unlike in the MRSA panel, the test sample is a stool instead of nasal swab. Therefore, the preparation of an effective panel required additional effort in terms of developing a preliminary step that consists in pre-cleaning a stool sample before placing it in the cartridge. We have successfully accomplished this, and our procedure is perfectly suited for usage in the form of an automatic chip. We are already working on its implementation, so the cartridge we manufacture will only require the application of a sample, which takes less than a minute – much less time than we assumed,” comments Marcin Izydorzak, co-founder, key shareholder and Member of the Board of Scope Fluidics S.A.

Clostridium difficile is an anaerobic bacterium that causes intestinal infection. Depending on the amount and type of toxins produced by the bacteria, the symptoms of infection can vary from a mild diarrhea to acute colitis, with large intestine obstruction or perforation leading to peritonitis, sepsis, or even death. As Clostridium difficile forms extremely resistant spores, and its development is promoted by antibiotic therapy, it is easily transferred and developed in hospitals. The number of infections has been steadily growing since 2000. Among the 450,000 new cases in the United States in 2011, as many as 30,000 were fatal. This made the bacterial infection the 17th most frequent cause of death in people aged over 65 years. According to Persistence Market Research, the global market value of the diagnostics and treatment of Clostridium difficile infection will amount to USD 1.3 billion in 2025, which, with the current value of USD 750 million, denotes an average annual growth rate of over 6%.

Nosocomial infections with MRSA and Clostridium difficile are not only a human, but also a financial issue for hospitals: the related costs are estimated at 2–3 billion USD per year in the United States alone and at around 3 billion EUR in Europe. Over 90 percent of Clostridium difficile infections have a hospital origin. The increase in medical care costs in the United States is over 7,000 USD per one patient infected with Clostridium difficile.

The PCR | ONE system is a response to the high demand for the development of methods for rapid and effective medical diagnosis, especially in the hospital setting. The system performs a fully automatic isolation and analysis of the genetic material of bacterial and viral pathogens in clinical samples. PCR | ONE is unrivaled in terms of speed and complexity of the analyses: it can recognize up to several dozen pathogens within around a dozen minutes after sampling.

The MRSA and Clostridium difficile panels applied in the PCR | ONE system will be used in the screening of all patients admitted to hospitalization and those undergoing emergency medical interventions. In the future, the Company will be able to easily extend the functionality of the PCR | ONE system with new test panels.

Technologies used in the system are protected by a patent in the USA. The Company is in the process of acquiring patents in other countries, including throughout the European Union.