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Highlights 2015Breaking New Ground in Infection Diagnostics

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Concluding statement at the G7 summit in Schloss Elmau, 8 June 2015, point 17

“We will promote the correct use of antibiotics and take part in strengthening

basic research, research into epidemiology, infection prevention and control

and the development of new antibiotics, alternative treatments, vaccines and

quick tests...”

The InfectoGnostics research campus in Jena pursues the goal of

researching solutions for rapid and cost-effective on-site analysis of

infectious diseases, and converting these into marketable solutions

with industrial partners.

Partners and interested Parties in tHe infectoGnostics researcH camPus

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The InfectoGnostics research campus is forging new paths as a public

private partnership in infection diagnostics and infection research. In

a triad of technology, application and production, more than 30

partners from science, medicine and industry are researching and

developing marketable solutions for rapid and cost-effective on-site

analysis (point-of-care testing) of infections – such as pneumonia

(e.g. caused by antibiotic-resistant pathogens) and tuberculosis in

human medicine, test systems for animal diseases and detection of

pathogens in food. As part of the central campus project “Innovative

diagnostics for pneumonia with immunosuppression”, seven partners

from science and industry are researching and developing handy tests

for quick, non-invasive diagnosis of pathogens causing pneumonia and

their resistance characteristics.

researcH camPus for tHe diaGnosis of infectious diseases and infection researcH

Public Private Partnership for Innovation

The InfectoGnostics research campus is one of nine winners of the

funding initiative “Research campus – public private partnership for

innovation” by the Federal Ministry of Education and Research (BMBF).

This initiative is one tool in the Federal Government’s "Hightech

Strategy". After a positive evaluation by the jury, InfectoGnostics has

entered the first five-year main phase in February 2015.

With the help of this public private partnership, a European centre for

infection diagnostics will be established that will be characterised by

excellent research and training in the interplay between basic research,

application and transfer.

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BreakinG new Ground in infection diaGnostics

The InfectoGnostics research campus started

work three years ago. The public private

partnership is based on close collaboration, trust

and the continuous exchange of ideas between

partners from science, medicine and industry.

The three founding partners and InfectoGnostics

directors Professor Dr. Jürgen Popp, Leibniz

Institute of Photonic Technology, Professor Dr.

Michael Bauer of the Jena University Hospital

and Dr. Ralf Ehricht of Alere Technologies GmbH

met to discuss initial progress and to venture a

glimpse into the future.

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We share our expertise with the scientists in the research institutions,

so that they can design their laboratory prototypes to be practicable from

the outset. We constantly discuss what the current requirements for tests

are with the medical experts, e.g. against the background of increasing

antibiotic resistance. The feedback from medical professionals is also very

important to us, to ensure that newly developed apparatus is easy to use

and will fit into the daily routines of the hospital or practice.

Jürgen Popp: This is what makes the research campus special: the triad

of research, medicine and industry working under one roof. IPHT and

the University Hospital of Jena have already worked closely together for

several years to exchange ideas and generate solutions which are tailored

to “unmet medical needs”. The research campus has enabled us to put this

on a permanent footing, and bring further partners on board, particularly

from industry. This means that we can cover the whole innovation chain,

and obtain product solutions which are useful to patients.

michael Bauer: The need for structured collaboration and interest in

the research campus’s topic is great. The idea of collaboration must

nevertheless become more permanent – including with the next generation

of scientists.

ralf ehricht: We therefore see encouraging the next generation as a very

important task within the research campus. Young academics who become

familiar with the “working under one roof” structure in their first years

in the profession, carry this on. In a few years’ time, we will notice a

discernable change in thinking in the quality of collaboration.

Where do you see the InfectoGnostics research campus in five years’

time?

Jürgen Popp: It is important to make the successful work carried out

so far more permanent over the coming years, and to drive forward our

work as part of the central campus project “Innovative diagnostics for

pneumonia with immunosuppression” in accordance with the aims we

have set ourselves. At the same time we have to reinforce the topics

of inter-regional networking and internationalisation. Because improved

diagnosis of infections is not only an issue for Thuringia but a worldwide

aim.

michael Bauer: As part of the campus project, we look at faster diagnosis

of pneumonia in immunocompromised patients. Over the next few years,

however, as well as current developments we must also bear in mind the

emergence of new antibiotic resistance. Because only if we can adapt our

technological solutions to medical needs, will we be successful.

ralf ehricht: InfectoGnostics has the exciting and challenging task of

accelerating the development of technological solutions and filtering out

the best systems from the technical innovations on offer. Our aim is to

develop market-ready solutions for the quick and inexpensive on-site

analysis of infectious diseases as soon as possible. The first solutions

have already been launched, and we look forward to being able to support

them.

Mr Bauer, how did the idea of forming a research campus on the topic

of “Breaking new ground in infection diagnostics ” come about?

michael Bauer: We need faster analysis systems in hospitals to identify

the pathogens causing infectious diseases such as sepsis or pneumonia.

Previously available standard diagnostic procedures often require 12-24

hours to provide reliable information on the pathogens and their resistance

potential, but doctors need quick results so that they can start appropriate

treatment for a life-threatening infection. At the moment if there is a

suspected infection, a broad spectrum antibiotic will often be given. In

times of increasing resistance, however, this cannot be a permanent

solution. In addition to improved hygiene in hospitals and the development

of new antibiotics, the aim must be to provide faster diagnosis.

Mr Popp, how do you intend to solve the problem?

Jürgen Popp: Together with our partners from medicine and industry,

we want to convert the latest scientific findings from the fields of optics

and photonics, molecular biology and microfluidics as quickly as possible

into user-friendly diagnostic and analytical methods. Optical technologies,

in particular, are developing rapidly and have the potential to be used

profitably for diagnosis and treatment in infection medicine. With light

we can obtain biochemical and molecular information about infection

pathogens and the immune response of the host directly from bodily fluids

and tissue quickly, easily and without contact.

Mr Bauer has given specific examples of medical

requirements, Mr Popp has a technological solution. Mr

Ehricht, what is industry’s role in this?

ralf ehricht: The path from an idea to its implementation in an actual

product is a long one. Our job is to bring a product to the market, and

therefore to the patient – at an affordable price. We know the market

requirements and licensing hurdles, and can advise the scientists

accordingly. We have comprehensive experience in the area of on-site

diagnostics, for example of HIV, tuberculosis and other diseases which we

bring to the research campus.

Members of the Board of InfectoGnostics Research Campus e. V.:

Professor Dr. Jürgen Popp, Leibniz Institute of Photonic Technology,

Professor Dr. Michael Bauer, Jena University Hospital and

Dr. Ralf Ehricht, Alere Technologies GmbH (from l. to r.)

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Selected publications

The book “modern techniques for Pathogen detection”, published by

members of the InfectoGnostics Board Prof. Dr. Jürgen Popp and Prof.

Dr. Michael Bauer provides a comprehensive summary of new diagnostic

methods for infectious diseases. This publication is aimed at a broad

target group – from technologists through medical users to firms which

develop and sell medical diagnosis equipment. Many

employees of the InfectoGnostics research campus

have contributed to this description of the latest

methods.

Jürgen Popp (publisher), Michael Bauer (publisher):

Modern Techniques for Pathogen Detection, Wiley-

Blackwell, ISBN: 978-3-527-33516-9

Another publication focuses on the topic “microrarray-based

detection of staphylococcal proteins”.

Direct, Specific and Rapid Detection of Staphylococcal Proteins and

Exotoxins Using a Multiplex Antibody Microarray.

Stieber B, Monecke S, Müller E, Büchler J, Ehricht R.

PLoS One. 2015 Dec 1;10(12):e0143246. doi: 10.1371/journal.pone.0143246.

eCollection 2015.

For an up-to-date list of publications originating from the research

campus, see www.infectognostics.de

Bridge strengthens interdisciplinary work

In September 2015 a 13-meter long bridge was constructed between

the Centre for Applied Research (ZAF) and the Institute for Physical

Chemistry (IPC) at the Friedrich Schiller University of Jena. This spatial

link will in particular improve interdisciplinary work under one roof at the

InfectoGnostics campus. It means that InfectoGnostics partners now have

more than 1,000 square metres of directly connected laboratory and office

space available to them. This is the basic pre-condition for an optimum

exchange of ideas between scientists.

annual review 2015

New partners in the public private partnership

In 2015 InfectoGnostics welcomed three new partners:

The Darmstadt diagnostics company R-Biopharm is the first partner on

the research campus from outside Thuringa. The aim of the partnership

is close collaboration in the fields of clinical diagnosis and water analysis.

R-Biopharm also brings its expertise in the area of marketing to the public-

private partnership.

QUANTIFOIL Instruments GmbH with its headquarters in Jena develops

laboratory equipment and modules aimed at automation, and will bring its

expertise in this area to the public-private partnership.

The start-up company BLINK AG from Jena is developing a new open

product platform for in-vitro diagnosis to make it possible for the most

varied partners to develop and sell their own IVD products on a joint

technical basis.

Driving forward biotechnology in Germany

Since September 2015, the

InfectoGnostics research campus has

been a member of the BioRegions study

group. InfectoGnostics is thus the only

initiative from the Thüringen BioRegion

in this network. The aim of membership

is to encourage collaboration with the

other bioregions, and drive forward research, development and marketing

of biotechnologies.

Professional advisory council meeting

The professional advisory council of the InfectoGnostics research campus

met on 19 June 2015 for its inaugural session. At this meeting, biochemist

and molecular biologist Dr. Konrad Sachse was elected Chairman of the

advisory council. With expertise in science and industry, the advisory

council members support the strategic development of the research

campus. The board of trustees of the InfectoGnostics research campus

unanimously appointed the advisory council in October 2014. The meeting

of the advisory council means that all InfectoGnostics committees have

now been appointed and are empowered to act.

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InfectoGnostics on YouTube

Since 2015, the research campus InfectoGnostics has its own YouTube

channel. So far viewers can watch two clips: a short introduction to

the research campus and a film about the campus project “Innovative

diagnostics for pneumonia with immunosuppression". Further films on

suitable topics from InfectoGnostics are to be continuously added.

Medical technology: from idea to product – but how?

On 3rd and 4th July 2015, a workshop was held in Jena on “Optical

diagnostics – potential and trends. From idea to product – but how?”

At the workshop, representatives of medicine, science and industry from

throughout Germany exchanged ideas on how optical and phototonic

procedures get from research to the market, and therefore into hospitals.

These optical and phototonic technology procedures have great potential

to be used profitably in diagnosing and treating diseases. But of course,

the conversion of innovative technologies into a marketable product is

often difficult. The reasons for this were highlighted during the workshop

in intensive discussions with representatives of industrial companies.

The workshop was organised by the Leibniz Research Alliance “Medical

technology: diagnosis, monitoring and treatment,” the Leibniz Institute

of Photonic Technology and the InfectoGnostics research campus. The

around 60 participants included representatives of project sponsors and

regional organisations. International workshop on optical diagnosis of infectious diseases

At the workshop “Optical Diagnosis of Infectious Diseases”, 40 scientists,

representatives of industry and medics discussed the requirements

for optical methods (e.g. Raman spectroscopy) to diagnose infectious

pathogens and their resistance characteristics. Existing gold standards and

new approaches to analysis were compared. The workshop was organised

by InfectoGnostics research campus and the European COST Action

Raman4Clinics, and took place on 21st and 22nd October 2015 in Jena.

Presence at trade fairs and events

The research campus InfectoGnostics presented itself to the general public

and professionals at trade fairs and events in 2015:

• Exhibition for the international Year of light,

• 15 – 17 January 2015, Jena/Germany

• 16th German Biotech conference,

22 – 23 April 2015, Cologne/Germany

• laser world of Photonics, 22 – 25 June 2015, Munich/Germany,

Organisation of an Application Panel on the topic “Visions for

future Diagnostics” with technologists, clinicians and commercial

enterprises.

• sepsis congress of the German sepsis association (dsG),

9 – 11 September 2015, Weimar/Germany

Direct to the InfectoGnostics YouTube channel

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As part of the research campus project supported by the BMBF, seven partners of InfectoGnostics have since February 2015 been researching reliable, fast and minimally invasive methods for the diagnosis of pathogens causing pneumonia and their resistance characteristics. The aim is to research and develop handy and easy-to-use systems which make it possible for diagnosis to be carried out close to the patient.

Lung and respiratory diseases are among the world's ten leading causes of

death. The cost of respiratory diseases in Germany adds up to 5 percent of

the health budget (around twelve billion euros). In people with weakened

immune systems, pneumonia can be caused by a variety of pathogens

which are difficult to detect in some cases and are not always addressed

by standard antibiotics. Many of these pathogens also have resistance to

antibiotics, which make them difficult or even impossible to treat.

The technological basis for this is a direct diagnosis of pathogens that

is largely independent of cultivation. Taking and processing a sample is

being simplified and miniaturised. Instead of samples which are taken

from the lungs by time-consuming bronchoscopy, sputum, urine or blood

can be examined directly. To determine the pathogen or the host response

to the infection, new methods for duplication of the genetic material

are researched and direct light-based methods such as microscopy or

spectroscopy are further developed.

The project is an association between five universities and research

institutions as well as two companies, all of which are partners of

InfectoGnostics Research Campus. The subprojects progress along the

innovation chain from determining medical need and developing new

technologies to preparing samples and producing prototypes and new

tests.

Participating partners

• Alere Technologies GmbH

• Analytik Jena AG

• Jena University Hospital

• Leibniz Institute of Photonic Technology

• Leibniz Institute for Natural Product Research and

Infection Biology – Hans Knöll Institute

• Friedrich Schiller University Jena

• Ernst Abbe University of Applied Sciences Jena

research aims

• To treat patients correctly and in a personalised way,

• to save time and costs,

• to develop a non-invasive diagnostic process and

• to make on-site treatment possible.

duration: 01.02.2015 – 31.01.2020

Project volume: 14.7 mill. Euros

diaGnosTiCs for Pneumonia witH immunosuPPression

Graphic summary of InfectoGnostics campus project “Innovative diagnostics for pneumonia with immunosuppression”

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Staphylococcus aureus is a bacterium which inhabits the nasopharynx of

many healthy people. Around one third of the population is colonised by

S. aureus. colonisation can be the cause of a serious infection such as

pneumonia. Various isolates of S. aureus are in some cases highly different

in their virulence factors. These factors include, for instance, toxins

produced by the bacterium. Which individual factors and combinations of

factors are associated with the development of diseases has so far been

insufficiently known.

S. aureus is identified by taking a sample from the patient’s naso-

pharynx. A positive finding does not currently lead to treatment, as the

doctor cannot know whether colonisation will lead to an infection or not.

“This is a diagnostic problem – particularly for immunocompromised

patients who are very susceptible to infections such as pneumonia,” says

Professor Löffler. In particular strains of S. aureus which are methicillin-

resistant (MRSA strains), i.e. resistant to all beta-lactam antibiotics such

as penicillin available on the market; for these patients an expensive

and onerous antibiotic treatment is often initiated. The need for such a

treatment cannot, however, be precisely evaluated at present.

“In order to provide a more reliable diagnosis, as part of the campus

project we want to identify virulence prototypes which make it probable

that S. aureus will cause an infection,” says Professor Löffler. The

virulence of a strain is determined by the interaction of many factors.

A more precise analysis of these factors and their effects will form the

basis for development of a test system.

Professor Löffler together with her team of six colleagues

is characterising RNA molecules of S. aureus isolates from

pneumonia patients for this purpose (transcriptome analysis).

With the proteome analysis also used, the proteins which can be formed by

the S. aureus are determined quantitatively. In comparison with isolates

from healthy people, conclusions can be drawn about the virulence factors

which trigger pneumonia. Professor Löffler has already been working on

the virulence factors of S. aureus, in particular the toxins and interaction of

the bacteria with the host, for over ten years. “Within the research campus

we have the opportunity to concentrate on one particular infection. We are

particularly interested in which toxin cocktail triggers pneumonia,” explains

Löffler.

The basis of her work as part of the InfectoGnostics project is a cohort of

immunosuppressed patients and the development of an InfectoGnostics

pathogen biobank. This is the only way in which a sufficient number of

samples can be taken and analysed. This also takes place within the campus

project. The development of a test system on this basis to distinguish

colonising S. aureus strains from infecting strains makes it possible to

optimise current treatment options. “In combination with the development

of a quick test to identify multi-resistant gram-negative bacteria, which

is also taking place as part of the project, we can significantly improve

the diagnosis of pathogens in pneumonia and the quick testing of their

resistance characteristics, “says Löffler.

As part of the project, Professor Löffler is also carrying out a colonisation

study. This is investigating how high the colonisation rate with S. aureus

is in children in Jena in comparison with adults. The colonising strains

are also being more closely analysed. This information is very important

for developing guidelines as to which patients should possibly undergo

decolonisation measures before hospital stays and operations.

determininG virulence factors of STAPHyLococcUS AUREUS

Professor Dr. Bettina Löffler, Head of the

Institute of Medical Microbiology at the

Jena University Hospital, is working on

characterising the virulence factors of

Staphylococcus aureus in pneumonia as

part of the InfectoGnostics campus

project “Innovative diagnostics for

pneumonia with immunosuppression.”

The aim of her work is more reliable

diagnosis as the basis for better

treatment decisions.

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managing Board

Prof. Dr. Jürgen Popp, Leibniz Institute of Photonic Technology

Prof. Dr. Michael Bauer, Jena University Hospital

Dr. Ralf Ehricht, Alere Technologies GmbH

medical advisors Prof. Dr. Bettina Löffler and Prof. Dr. Mathias Pletz, Jena University Hospital

Board of Trustees General assembly advisory council

officereviewers

ad hoc committee

orGanisation cHart leGal notice

The Managing Board represents the association

externally and controls the activities of the association

and the research campus together with the Board of

Trustees and the General Assembly. Along with the

Board of Trustees, it is responsible for coordination and

strategy development and reviews the implementation

of the IP policies and guidelines for use. The Board is

supported by two Medical Advisors. As a supervisory

committee, the Board of Trustees sets the policies

and is also responsible for campus development

in addition to management of the association. The

General Assembly offers all members a platform for

the presentation and expression of their interests. The

Advisory Council advises the association on scientific

and business matters. An ad hoc review committee is

used for independent project evaluation. It is composed

of experts in the respective project topics who conduct

a preliminary evaluation of the submitted projects. The

office is the central contact for all partners, members and

interested parties. It is responsible for communication,

management and public relations.

Publisher

InfectoGnostics Research Campus

Jena, Reg. Assoc.

Philosophenweg 7

07743 Jena, Germany

editor

Britta Opfer, IPHT Jena

Graphic design & typesetting

Daniel Siegesmund, IPHT Jena

Photo credits

• Sven Döring, Focus Agency

(Hamburg), p. 4, 12, 19

• Friedrich Schiller University Jena,

p. 11

• Photo studio Ebenbild (Jena), p.

6, 8, 10, 16

• shutterstock.com, cover

infectoGnostics research campus Jena, reg. assoc.

Centre for Applied Research

Philosophenweg 7

07743 Jena, Germany

Phone.: + 49 3641 948 303

Fax: +49 3641 948 302

Mail: info@infectognostics.de

www.infectognostics.de

Follow us on Twitter: twitter.com/InfectoGnostics