„PCR is ideal for Sepsis-Diagnosis in several respects. However, its major advantage is that results are available to physicians much sooner than presently“, says Mr. Herrmann, responsible Project Manager at Bremen based Molzym GmbH. Indeed, results are already available within four to six hours compared to current standard procedures that take commonly between one and up to three days. This provides considerable advantages in decision making on therapeutic measures. On top of that, pathogen detection is also not affected in case antibiotic therapy has already commenced. In contrast, current diagnosis by means of blood culture is often compromised and delayed.
This raises the question, why this molecular diagnosis method has not yet conquered clinical laboratories? A small number of germs are already sufficient to cause septicaemic diseases. Hence, diagnosis has to be highly sensitive. Up to now, increased sensitivity is decreasing reliability of results, was a rule in PCR-Diagnosis. “We not only achieved crucial improvement of sensitivity but also significantly increased reliability of PCR-diagnosis”, Mr. Herrmann proceeds.
This has become feasible by taking a completely novel approach. It was not attempted to solve the numerous single problems that may arise in PCR analysis and that are partly system immanent. Instead, a solution was developed that excludes errors at the outset. This was possible by utilizing a novel, pre-analytical tool, therefore a procedure upstream of PCR analysis. Further advantages of this method are also its ease of use and being rapid. Moreover it is applicable in combination with all PCR-assays and is also easily adapted to automated systems. The procedure was developed in co-operation with clinical research facilities and institutes and is available as a commercial kit under the name MolYsis.
At present, the procedure is tested in pre-clinical trials that are supported by the state of Bremen. Several European hospitals and blood banks have started to test the procedure in comparison to standard methods as well. “We are overwhelmed by the responds our work receives”, rejoices Mr. Herrmann. Users in practice are constantly finding new areas of application for the procedure next to sepsis-diagnostics. Currently the procedure is adapted to blood products, biopsy specimens, but also transplants such as heart valves.
Source: Molzym GmbH & Co.KG, Bremen