Anagnostics Bioanalysis (St. Valentin, Austria) and Molzym (Bremen, Germany) announced today a license agreement and partnership to commonly develop hybcell Pathogens DNA, a ground-breaking system for rapidly identifying sepsis causing pathogens out of whole blood. The deal includes the in-licensing of Molzym’s SepsiTest™ sample preparation, which is used for DNA extraction from sample material containing low loads of pathogens.

Together with Anagnostics’ disruptive multiplexed hybcell technology identification of pathogens will be accomplished in less than four hours, improving the prognosis of septic patients significantly. Early and fast diagnosis of pathogens is crucial for the survival of patients – especially in the initial phase of a developing sepsis. Testing from whole blood overcomes the need for microbiological breeding and reduces time for test results from one or more days down to four hours.

Markus Jaquemar, Managing Director of Anagnostics Bioanalysis comments the alliance: ‘The in-licensing of Molzym’s SepsiTest™ marks the completion of Anagnostics’ unique approach of integrated sepsis testing: beside the initial pathogen detection based on DNA inflammatory markers are tested to monitor patient’s response to therapy.’

Sepsis a deadly threat

How relevant this could be, show the following facts about sepsis: Sepsis is a deadly disease that leaves no clear track back to initial indications, which could include gram-positive bacteria, gram-negative bacteria or fungi. The results are devastating: the annual incidence rate of sepsis has increased 91.3 percent over the last 10 years, and every hour 25 people in the United States die from severe sepsis. One of every three patients who develop severe sepsis will die within a month. Severe sepsis, the leading cause of death in the non-coronary intensive care unit, takes more lives than breast, colorectal, pancreatic, and prostate cancers combined.

Joint development

The development of hybcell Pathogens combines the existing and CE-IVD marked SepsiTest™ from Molzym and Anagnostics’ pathogens detection based on the proprietary compact sequencing technology. SepsiTest™’s microbial DNA enrichment is based on MolYsis technology enabling up to 40,000-fold DNA enrichment over conventional technologies. In contrast to competing technologies, MolYsis removes DNA from dead microbes and thus, by measuring declining loads of pathogens, allows for timely monitoring of successful antibiotic treatment.

Anagnostics’ compact sequencing is a simple two-stage process for application in clinical routine labs. A set of clinically relevant mutations is analysed and transformed into results – a comprehensible list of pathogens present in the sample is derived from mutations. The process is fast (less than 2 hours) and accurate.

Prof. Dr. Michael Lorenz, Chief Scientific Officer at Molzym states: ‘The SepsiTest™ microbe enrichment technology has become a standard for performing accurate, rapid and cost-effective molecular sepsis diagnosis. We are happy to employ our technology in a very promising integrated sepsis diagnostics concept.’

Markus Jaquemar adds: ‘hybcell Pathogens will be a truly game-changing product in sepsis diagnostics, as fast and accurate results and feedback are demanded. Every hour of delay treating patients with matching antibiotics results in an 8 % increase of mortality rate. hybcell Inflammation monitoring patient response is unique and supports personalized therapeutic decisions for the first time.’

The first tests are available in late autumn 2012.

Integrated approach

A unique feature of Anagnostics is the ability to measure DNA und proteins on the same system (with different tests). An urgent demand of clinicians is the one to know about patient’s response to the infection itself and to treatment. Using Anagnostics’ multiplex capability a panel of currently 12 markers is provided as a fast and robust test to clinicians. In less than 30 minutes the level of inflammatory markers like CRP, procalcitonin, interleukins and others are provided. As monitoring is by nature a repetitive action, the development over time – or dependent on therapeutic interventions – of these levels is examined and presented to clinicians. So an integrated approach – spanning from the initial examination of sepsis causing pathogens to the measurement of patient’s response, for example to treatment options – is offered for the first time.

About Anagnostics

Austrian Anagnostics Bioanalysis focuses on development and production of systems and kits for multiplexed routine testing in clinical diagnostics (drugs of abuse screening, pharmacogenetics and severe infections). The combination of DNA and protein tests on the same device (hyborg) enables innovative and efficient diagnostic solutions for the rapidly growing demand driven by personalized medicine. Since 2006 a young team around molecular geneticist and biochemist Dr. Bernhard Ronacher develops multiplexed analytical systems (hyborg) and tests (hybcells). The patented hybcell is the world’s first cylindrical microarray and core of Anagnostics’ technology. Based on this hybcell, complete test kits are assembled and fully automated processed by the hyborg.

The hyborg platform is a versatile and integrated hardware platform for the detection of a broad panel of DNA (e.g. pathogens) and protein biomarkers (e.g. inflammation) from a single sample. hyborg processes hybcells (disposable cartridges) providing the necessary reagents to complete the analysis from sample to report. Up to 8 hybcells are processed automatically. For further information please visit www..anagnostics.com

About Molzym

Molzym, headquartered in Bremen, Germany, is a manufacturer of innovative products for molecular diagnostics. Molzym’s diagnostic products focus on proprietary technologies for the selective isolation of pathogen DNA from various clinical specimens. The new automation platform, selectNA™, allows for up to 40,000-fold better PCR sensitivity as compared to conventional DNA isolation protocols. The system therefore enables culture-independent direct testing of blood and supports the universal detection of pathogens causing culture negative infections. For further information please visit www.molzym.com