Anagnostics and Molzym Form Strategic Alliance Fighting Sepsis

Anagnostics Bioanalysis and Molzym have announced a license agreement and partnership to commonly develop hybcell Pathogens DNA, a 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 analyzed 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.