INTEGRATED. ADVANCED. SOLUTIONS.

I N T E G R AT E D. A DVA N C E D. S O L UT I O N S.

F O R M I DA B L E E X P E RT I S E

P R OV E N PA RT N E R S H I P S

F L E X I B I L I T Y

H I G H LY I N N OVAT I V E

LO O K I N G TO T H E F UT U R E

CO M M I T T E D TO Q UA L I T Y

S U CC E S S H A S A N A M E

2 STRATEC designs and manu-

factures fully automated

analyzer systems for partners

operating in the fields of

diagnostics and life science.

Established in 1979 the

company later focused on

the core activities of OEM

development and production

of integrated solutions for

global players within the

area of diagnostics and life

science.

STRATEC Biomedical

Systems AG – technology

leader in fully integrated

automated analyzer

systems. Together with its

affiliates Ballista, Invitek,

Robion and Sanguin, the

STRATEC group forms a

one-stop solution provider

to the diagnostic industry.

STRATEC’s cutting-edge

products have proved to be

particularly successful in the

areas of laboratory diag-

nostics and life science.

Based on existing product

platforms and using the

benefits of an effective cost

structure, highly innovative

and customer-oriented

products are developed

within a time frame of 18

to 36 months.


Ballista specializes in pre-

cision optics technology and

related development, pro-

duction and advisory services

with a strong track record as

a supplier to the diagnostics

BALLISTA

and medical technology,

biotechnology and aerospace

industries. Its expertise and

capacities range from proto-

type assembly through to

series production.








Robion AG produces high-

complexity analyzer systems

ROBION

for clinical diagnostics

applications.

Sanguin’s powerful data

management software offers

enhanced workflow within

a laboratory. It improves

laboratory efficiency whilst

meeting ever more stringent

regulatory requirements.

SANGUIN

The highly successful Aurora

middleware provides con-

nectivity and automated

rules-based decision-making,

enhancing result manage-

ment and workflow of any

laboratory.

Invitek offers time-saving

proprietary reagent systems

for nucleic acid stabilization

and purification. In close

collaboration with clients

INVITEK

tailored products are de-

veloped for both manual and

automated workflows in

molecular diagnostics and

biomedical research.








STRATEC’s convincing

full-service offering

STRATEC offers a comprehen-

sive range of products and

services from a single source.

Our broad technology pool

includes:

● Liquid handling systems

● Software

● Robotics modules

● Detection modules

● Process validation

● Documentation services

● Regulatory approvals

● Workflow management

● Middleware

● MDx sample stabilisation

● MDx sample preparation

Supported by our premier

offering, our partners are able

to focus on their core com-

petencies, the development

of assays – with a positive

effect on development times.

Reducing time-to-market

has never been so easy!

STRATEC believes in

cooperation

Design and manufacture of

our superior range of pro-

ducts are based on propri-

etary, patented technologies

with a focus on integrated

solutions. While our partners

contribute their knowledge

of the market and their

specific chemistry know-how,

STRATEC, in turn, provides

competence and expertise

in the fields of science and

engineering as well as

automation and application

software. The result of

this partnership approach:

highly efficient, tailor-made

analyzer systems that meet

our customers’ requirements

in every respect.

STRATEC’s comprehensive

consulting service

Every day, new technologies

are being developed in the

domain of diagnostics and

life sciences, accompanied by

changing regulatory require-

ments and the need to

permanently adapt processes

to their specific environment.

In order to support their

instrumentation activities,

STRATEC offers its customers

comprehensive consulting

expertise in the fields of

project management, hard-

ware and software engineer-

ing as well as verification

and production.

With more than 30 years of

experience and a profound

knowledge of cutting-edge

technologies and regulatory

affairs STRATEC provides its

partners with most valuable

support throughout all

phases of the system life

cycle.


Siemens Healthcare Diagnostics

5

6 Integrated solutions for

tailor-made products

STRATEC’s ongoing commit-

ment to the target-oriented

development of highly effi-


Fully integratedjoint development

System integration

Production management

Diagnostics companies● Market expertise● Reagents, chemicals● Test procedures● Approval and

registrationO E M S T R A T E G Y

STRATEC● Automation● Application software● Hardware development● Verification● Preparations for approval

and registration

Integrated solutionsfor blood banks,

clinical laboratories andresearch facilities

cient modular systems

allows customized solutions

required for new applica-

tions to be produced in the

shortest of time frames.

Proven hardware, intelligent

software modules and

STRATEC’s cutting-edge

system platform concept are

the warrants of your success.
















Integrated solutions

for perfect analyzer systems

� LIAISON® DiaSorin

� TANGO® optimo Bio-Rad

� BEP 2000 Advance® Siemens HealthcareDiagnostics

ETI-Max 3000 DiaSorinQuickStep® Bio-RadEVOLIS™ Bio-Raden4lisa Abbott DiagnosticsEUROIMMUN Analyzer I EUROIMMUNImmunomat™ TWINsystem virion\serionELISYS QUATTRO HUMAN

� Galileo NEO ImmucorGamma

� DAVINCI® bioMérieux

� ADVIA Centaur® CP Siemens HealthcareDiagnostics

� Procleix® Optiva™ FEP Novartis

� CyBi®-RoboSpense CyBioLABXpress™ One Lambda

EVOLIS™ Twin Plus Bio-Rad

Pure Open for partners

� InviGenius Invitek

� GEMINI Open for partners

Lean production

Thoroughly tested functional

modules, constantly moni-

tored by regular quality audits,

are used to manufacture

more than 2,000 complex

analyzer systems per year.

Highly experienced production

teams are deployed to assem-

ble complete systems from

modules supplied just in time

and to perform all relevant

testing processes. After com-

pletion of the final inspection

tests using customer reagents

the analyzer systems are ready

for dispatch. STRATEC’s GMP

compliant and FDA inspected

manufacturing facilities allow

systems meeting the highest

quality standards (e.g. CSA/UL)

to be manufactured at most

competitive prices.

�

� �

� �

� �

� �

� �

Announced product launches 2010

● DiaSorin LIAISON® XL● Gen-Probe Panther TM● QIAGEN QIAensemble HC 400

Cutting-edge design

solutions

Developing new analytical

methods, permanently im-

proving the technology used

in established applications

and further enhancing the

productivity of laboratory dia-

gnostics systems – these are

the topics we will be focusing

on in the near future.

STRATEC is actively participat-

ing in research projects and

cooperating with various

companies to further extend

its experience using new

technologies, such as the

label-free methods, as well

as in new diagnostics fields,

such as cellular analysis.

10


By investing extensively in

the development of central

system components, we

enable our partners to work

with the smallest reagent

volumes, high-precision pro-

cess monitoring and obtain-

ing the best analytical per-

formance.

Exponential growth in

research and development

STRATEC employees are

working in an environment

in which they grow with the

challenges such as the control

of analyzer systems and labo-

ratory robots, mathematical

data analysis, the develop-

ment of databases to archive

diagnostic data, transfer of

diagnostic results, continuous

quality control of analytical

processes, remote monitoring

and diagnosis of systems via

internet, networks, and many

others. Likewise, maintaining

the highest quality standards

in precision engineering

forms part of our daily

demanding routine.








STRATEC focuses on the

needs of users in clinical la-

boratories and blood banks.

By ensuring excellent relia-

bility, harmoniously integrat-

ing systems into daily routine,

and offering an ergonomic

software interface, it thus

facilitates maximum pro-

ductivity at its partners.

Our strong software team

and our innovative, high-

performance middleware

platform act as guarantors

enabling us to continually

offer new, successful concepts

not just in new systems, but

also to provide laboratory

users within our existing

OEM cooperations with per-

manently up-to-date func-

tionalities and instruments.








13at all times with the express

purpose of capturing new

markets quickly and effi-

ciently – together with our

OEM partners.

One key characteristic of

the companies within the

STRATEC Group is their com-

mitment to organizing their

business processes so as to

ensure compliance with

regulatory requirements

while guaranteeing econo-

mic viability. Our complaint

handling system including

a crossdepartmental error

analysis and risk assessment

supports our customers’

service and vigilance pro-

cesses as well as their risk

management.

The companies within

the STRATEC Group have

maintained certified quality

management systems for

many years now

In addition, our customers

are actively involved in the

key elements of our change

control process. By offering

our customers, diagnostics

companies acting on a mar-

ket characterized by regu-

latory restraints, significant

and valuable benefits for the

observance of the applicable

regulatory requirements,

STRATEC vitally contributes

to strengthen improve

improve your leading edge in

the market place.

Certifications/registrations:

● DIN EN ISO 9001:2008

● DIN EN ISO 13485:2007

● ISO 13485 CMDCAS

● FDA registered (compliant

to 21 CFR Part 820)

● CSA/UL registered

STRATEC’s commitment to

continuously enhance this

system and to adapt its quali-

ty management to the ever-

changing business, legal and

regulatory environment is

the key to consistent quality

throughout the STRATEC

Group.

Indeed, our clearly defined

processes throughout the

entire value chain – from the

beginning of development

through to mass production

– play a pivotal role when

it comes to securing a domi-

nant position in the market.

At the same time, our in-

cisive quality management

ensures that the necessary

regulations are adhered to


STRATEC Biomedical

Systems AG and the world of

finance – ISIN DE0007289001

Complying with the highest

standards for publicity

and transparency, STRATEC

Biomedical Systems AG

has been listed in Germany

since 1998.

We believe that transparency

and an open form of dialogue

with investors and the public

are integral elements of

trust and a precondition for

sustained success within the

financial markets.








Company history

1979 STRATEC is founded in Birkenfeld, Germany

1987 First medical systems aredeveloped

1993 Systems for bio- and chemilumi-nescence as well as coagulationapplications are launched

1997 STRATEC Biomedical Inc.is founded in the USA

1998 STRATEC becomes a stock corporation

2002 STRATEC NewGen GmbH isfounded in Birkenfeld, Germany

2005 Robion AG is founded in Switzerland

2006 Acquisition of Sanguin Inter-national Ltd. in the UK and itssubsidiary Sanguin InternationalInc. in the USA

2008 STRATEC Biomedical SystemsS.R.L. is founded in Romania

2009 Acquisition of Invitek Gesellschaft für Biotechnik & Biodesign mbH in Berlin,Germany

2010 Acquisition of Ballista Inc.in the USA


Sales pursuant to IFRS

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Earnings per share (EPS) pursuant to IFRS

47.3

67.568.4

Euro million

31.727.426.711.2

Employees (annual average)

91 102 115 144 168

0.02 0.10 0.11

0.28

0.43

0.70

0.88

Euro

40.4

0.17

191 208 229

61.0

2000 2001 2002 2003 2004 2005 2006 2007 2008* 2009*adjusted

0.72*

2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

238

79.6

291

1.03

STRATEC Biomedical Systems AGGewerbestr. 37 · 75217 BirkenfeldGermanyPhone: +49 7082 7916-0Fax: +49 7082 [email protected]

ST R AT E C G R O U P

1000

e · 0

7201

0

Birkenfeld-Gräfenhausen

Frankfurt

A5

A5

A6

A81

A8

A8

A6

Mannheim

HeilbronnNürnberg

Stuttgart

München

Karlsruhe

Strasbourg

Freiburg

Basel

Pforzheim

Navigation systems:

Birkenfeld Enzkreis or

Birkenfeld Württemberg.

You can reach us by car in

about 60 minutes from

Stuttgart airport (STR)

or from Strasbourg (SXB),

France.

The journey from Frankfurt

airport (FRA) takes about

90 minutes.

100 % 100 % 100 % 100 %

STRATEC Biomedical Systems AGBirkenfeld /Germany

STRATEC Biomedical Inc.Hamden/CT

USA

Sanguin International Ltd.Burton upon Trent

UK

STRATEC NewGen GmbHBirkenfeldGermany

Sanguin International Inc.Hamden/CT

USA

STRATEC Biomedical Systems S.R.L.

Cluj-NapocaRomania

Invitek Gesellschaft für Bio-

technik & Biodesign mbHBerlin

Germany

Ballista Inc.Newbury Park/CA

USA

Robion AGBeringen

Switzerland

INTEGRATED. ADVANCED. SOLUTIONS.

Documents