Targos is an international company that provides clinical biomarker services to support global clinical trials, with a focus on oncology and immunology. It has laboratories in Germany, the US, and China. Targos has experience screening over 100,000 patient samples and supporting over 100 clinical trials. Its services include pathology, molecular biology techniques like immunohistochemistry and next-generation sequencing, as well as project management, consulting, and training. Targos aims to help develop personalized healthcare through its biomarker research and clinical trial services.

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In Business for
Personalized Healthcare
Targos
Efficient·Reliable·Flexible
Targos Development
Biomarker R&D
Targos Advance
Training & Consulting
Targos Molecular Pathology
Clinical Biomarker Services

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About Targos
USA: Atlanta
USA: Issaquah
USA: San Bruno
China: Shanghai
Germany: Kassel | Cologne | Munich
Targos is audited annually since 2005 by FDA, Pharma PDQA and Biotech QA
Targos Molecular Pathology GmbH is accredited
by the Clinical Laboratory Improvement Amend-
ments Program (CLIA)
Targos Molecular Pathology is accredited by the
Commission on Laboratory Accreditation of the
College of American Pathologists (CAP)
In Business for Precision Medicine - Since 1999
Targos Offers Global Services
Professional Accreditations
Targos Facility in Kassel, Germany
Targos is a leader in clinical biomarker services.
Targos laboratories provide a unique comprehen-
sive molecular pathology capability and expertise
to support global clinical trials with a focus on
oncology and immunology. With a workforce of
around 100 world-class quality staff comprising
pathologists, molecular biologists, project mana-
gers, logistical personal and quality assurance
experts, the company is well positioned to
manage the increasing demand from pharma-
ceutical companies for all surgical pathology
and molecular biology work. The organization
provides a global CAP/CLIA/GLP quality capabi-
lity in Germany, USA and China with its partner
companies AKESOgen and WuXi respectively.
Since 1999, our team has screened over
100,000 patient samples and supported more
than 100 international clinical trials; which have
led to the successful approval of several
targeted therapies for breast and gastric cancer
(e.g., Herceptin®
, Kadzyla®
, Perjeta®
); NSCLS
(Tarceva®
) and Melanoma (Zelboraf®
).
Several CDx IVD tests have also been approved
in the industry (e.g. Dako-Agilent HER2
pharmDx™ IHC /IQFISH pharmDx™ kit for
breast & gastric cancer and the cobas®
4800
BRAF V600 Mutation Test for melanoma).
As part of the Herceptin Adjuvant (HERA) and
Trastuzumab for Gastric Cancer (ToGA) clinical
trials (N Engl J Med 353:1659-72, 2005; Lancet.
2010; 376:687-697), the company has trained
over 1000 pathologists from all around the
world including China on HER2 testing; scoring
guidelines in gastric cancer and on the diffe-
rences between breast and gastric cancer.

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Targos has screened more than 100,000 patients
as part of its clinical trial services. The company
has acted as a GCP compliant patho-diagnostic
reference center for more than 100 diagnostic tri-
als for international Pharmaceutical and biotech
companies. International customers and the US
Food and Drug Administration (FDA) have regu-
larly audited our projects and facilities. Targos
Molecular Pathology supports global clinical trials
with pathology services through board certified
pathologists, project management through PhD
trained managers, logistics (e.g., sample kits,
sample pick-up, re-shipment, storage, archiving),
data/quality management, assay development,
consulting and training according to full GCP
standards. We also serve all phases of biomarker
development from phase I-IV clinical trials.
Our pharma customers and the FDA
regularly audit Targos.
Global Clinical Trial Services Targos Laboratories
Immunohistochemistry
• Full Service Provider
• All Tissue Based Biomarkers
In Situ Hybridization
• DNA-ISH (FISH, DDISH,CISH)
• RNA-ISH
Immunofluorescence
• Multiplexing Services for Tissues and Cells
• Detection of Biomarkers
ELISA
• Quantitative Determination of Serum HER-2/neu
• Customized Assays for Detection of Target Protein
Phosphorylation
Tissue Microarray
• Custom Services for IHC and FISH Staining
• Quantification of Tissue Slides Stained by FISH and IHC
DNA/RNA Isolation
• From Fresh/Frozen and Paraffin Embedded Tissues
• State-of-the-Art Extraction and Analysis Methods
Macro & Microdissection
• On Formalin Fixed Tissues to Enrich for Tumor
• Microdissection undertaken by Board-Certified Pathologists
qRT-PCR
• Simultaneous Amplification and Quantitation of Targeted DNA
• Gene-Expression Profiling
Mutation Analysis
• Extraction of Genomic DNA from Fresh or FFPE Tissues
• Mutation call by qPCR using Mutation Specific Primers
Expression Profiling
• Affymetrix and NanoString Technologies
• Bioinformatic Analysis and the Delivery of a Scientific Report
Next Generation Sequencing
• Targeted Deep Sequencing
• Development of Proprietary Assays for Big Pharma
Project
Managers
Results
Reporting
&
Quality
Control
Pharma
and Clinical
Sites
LogisticsLogistics
Study
Office
Pathologists
Laboratory
Storage and
Archiving
Pathology
Services
Central Laboratory
Services
Consulting and
Training
Assay
Development
Clinical Trial
Consulting
Molecular Biology
Tissue Repository
Storage & Archiving
Customized
Assays
Clinical
Studies
Director
Service Operations
Our clinical trial services include
• Biomarker driven clinical trials for drug and/or IVD approval under GCP regulatory compliant con-
ditions with a rapid turnaround time for reporting of test results required for patient stratification.
• Biomarker translational research including prevalence analyses based on IHC or ISH, investigation
of phosphorylated proteins, the generation of tissue microarrays or nucleic acid based tests such
as next-generation sequencing, PCR based mutation analysis or RNA expression profiling.
• Assay development & validation according to ICH, ISO13485, USCAP & CLIA guidelines
• Logistics handling and sample shipment around the world.
• Laboratory Information Management System (LIMS) fully compliant to FDA CRF21 part 11 embed-
ded in a state-of-the art IT infrastructure ensuring a high level of data security.
• Archiving of samples at -70°C, -20°C, 4°C and at ambient temperatures completely integrated
into LIMS for sample storage and tracking.
• Web-based customer portal to check the sample status and to download test results.
Dedicated team of scientists offer assay esta-
blishment and validation of biomarkers according
to ICH, USCAP & CLIA guidelines. We further
assist in the approval and marketing process of in
vitro diagnostics by providing the required docu-
mentation for submission to regulatory agencies,
conducting clinical trials for IVD and/or drug
approval as well as the organization of end-user
training in our training facility at Targos.
Discovery of biomarkers include prevalence
analyses based on IHC/ISH, investigation of
phosphorylated proteins, the generation of tissue
microarrays or nucleic acid based tests such as
next-generation sequencing, PCR based mutation
analysis or RNA expression profiling.

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Involvement in Companion Diagnostics (CDx) Development Other Services and Collaborations
Biomarker
Research &
Discovery
Biomarker
Validation
Assay
Development
Assay
Validation
Clinical
Utility
Testing
Regulatory
Approval
(limited
involvement)
Manufacturing
(no involvement)
Marketing
- IHC
- FISH
- PCR
- Europe
- Middle-East
Approval Process
CDx Market
Training &
Consulting- On Site
- Custom
- Academia
- Industry
- International
Reference
Testing
Ring Studies Quality
Assurance
Targos supported:
• The first co-development of CDx for Roche cobas®
4800 BRAF V600 mutation test for melanoma
together with Genentech/Roche drug ZELBORAF®
(Vemurafenib) in a prospective clinical trial
• Dako-Agilent HER2 pharmDx™ IHC/IQFISH pharmDx™ kit for breast and
gastric cancer diagnostics
• Dako-Agilent HER2 IQFISH pharmDx™ kit as an aid in the assessment of patients
for whom Herceptin™ treatment is being considered
Targos Services:
Targos offers global support, vast experience and in-depth understanding
of the utilization of biomarkers in clinical practice.
This includes:
• on site and custom training around the world
• reference testing related to IHC, FISH and PCR
• beta testing
• inter-laboratory Multi-Center Reproducibility (Ring) Study
• quality assurance
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Pathology and Scientific Expertise in Biomarker Based Clinical Trials
and Next-Generation Sequencing
Our clinical pathology and scientific expertise are directed by Prof. Dr. med. Josef Rüschoff
(Chief Medical Officer) and Prof. Dr. med. Reinhard Büttner (Chief Scientific Officer). Together,
Profs. Rüschoff and Büttner have published over 500 peer-reviewed articles in high-impact journals
such as Nature, Nature Genetics, N Engl J Med, Lancet, Sci Transl Med, J Clin Oncol, Int J Cancer, etc.
Prof. Rüschoff has supported more than 100 international clinical trials since 1999, which have led
to the successful approval of several targeted therapies for breast/gastric cancer (e.g., Herceptin®
,
Kadzyla®
, Perjeta®
), NSCLS (Tarceva®
) and Melanoma (Zelboraf®
).
Prof. Büttner is an internationally recognized expert in mutation testing in lung cancer
(Nat Genet 44:1104-1110:2012), lung cancer genomics (J Clin Oncol 31: 1858-65: 2013) and
genomics-based classification of human lung tumors (Sci Transl Med 5, 209ra 153 (2013).
In collaboration with oncologists, he is actively involved in the application of genomics and
next-generation sequencing for individualized diagnostics and treatment of cancer.
The strong in-house expertise covers all tumor indications and is complemented
by a German and international network of pathologists.

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Targos Education Programs Services offered in the U.S. & China
Services Offered in the U.S. in Collaboration with AKESOgen
Targos and AKESOgen have formed a strategic partnership in the US to offer pharmaceutical and
biotech industry a wide-ranging package of traditional pathology and molecular biomarker solutions.
Services offered in the US include but not limited to:
Next Generation Sequencing
• Full Service Provider
• Consulting & Experimental design
• Bioinformatics Support
Epigenomics
• Whole Genome Methylation Profiling
• Bisulpite Treatment and Assays for FFPE Material
• Bioinformatics Support
Genotyping
• Custom Based Services
• Whole Genome SNP Analysis
• Whole Genome Copy Number Variation
DNA-RNA Extractions
• FFPE, Frozen Tissue and Biopsy Material, Cell Cultures
• Urine, Whole Blood, Stool, Saliva, Blood Cards
• Buccal Scrapes / Swabs and Mouthwash Samples
Gene Expression Analysis
• RNA Seq and Transcriptome (NGS)
• Microarray Services (Affymetrix and Illumina)
• qPCR
Bioinformatics & Biostatistics
• Transcriptomics, Proteomics, Epigenetics
• Pharmacogenetics/ Pharmacogenomics
• Genome-wide Association Studies (GWAS), Meta-analysis
Please contact info@targos-gmbh.de for more information about our Clinical Trial Services in the U.S.
Services Offered in China in Collaboration with WuXi AppTec
Targos provides know-how, services, and the quality standards to support WuXi’s molecular pathology
work for pharmaceutical customers in China. The collaboration focuses on the validation and analysis
of clinical tissue biomarkers in cancer. By adding these new testing services from Targos, WuXi will
provide customers with a comprehensive platform of services in soluble, cell, and tissue biomarkers.
Services offered in China include but not limited to:
Immunohistochemistry • HER2 testing (Breast and Gastric)
In Situ Hybridization • HER2 FISH Testing
Microarray Services
Full Spectrum Microarray Services
• Gene Expression, Copy Number and Cytogenetics
• GWAS and Genotyping
Next-Generation Sequencing
• Whole Genome, Exome and Tarrget Deep sequencing
• Transcriptome, Meta-Genome and Amplicon sequencing
• Epigenetics, MicroRNA, ChiP and DNA Methylation Sequencing
Please contact info@targos-gmbh.de for more information about our Clinical Trial Services in China.
Education Programs in the U.S. and Canada
ACCME Accredited Pathology Education NSH Certified Educational Units
• Short-Course
• Predictive Biomarkers:
Lessons from Clinical Trials
• Conducted through United States and
Canadian Academy of Pathology (USCAP)
• Three-day Course
• in situ hybridization, Microarrays
and NextGeneration Sequencing
• Conducted through National Society
for Histotechnology (NSH)
Education Programs in Germany
1-3 Day International
Biomarker Training Courses
for Pathologists and
Oncologists
Preceptorship Meetings
in Pathology
1-2 Week Practical Training
Courses for Medical
Technologists
• Standardization and
biomarker testing related
to IHC, FISH, CISH, SISH
and ddISH
• HER2 testing (FISH, IHC,
CISH, SISH, ddISH)
• EGFR testing (IHC)
• Focus on quality control
and standardization
• Breast cancer pathology
and correlation to clinical
oncology
• Gastric cancer pathology
and correlation to clinical
oncology
• Lung cancer pathology
and correlation to clinical
oncology
• In collaboration with
pharmaceutical com-
panies and thought
leaders, Targos provides
preceptorship opportu-
nities to the continued
training of new clinicians
within their clinical
practice
• In collaboration with
German Institute for
Training for Technologists,
Berlin, Germany.

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Impressions of Targos Impressions of Targos
Visit us at: www.targos-gmbh.de

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United States:
Targos Inc.
1001 Bayhill Drive, 2nd Floor,
San Bruno, CA, 94066. U.S.A.
Phone: +1 650-616-4075 (Direct Line)
Phone: +1 650-616-4000 (Reception)
Fax: +1 650-616-4001
E-Mail: info@targos-gmbh.de
Targos Inc.
24506 SE 45th Way
Issaquah, WA, 98029. U.S.A.
E-Mail: info@targos-gmbh.de
Targos
Molecular Pathology GmbH
Germaniastrasse 7
D-34119 Kassel, Germany
Phone: +49 561-50045299
Fax: +49 561-50045355
E-Mail: info@targos-gmbh.de
Germany:
Targos
Molecular Pathology GmbH
Gleueler Str. 176-178
D-50935 Köln, Germany
Phone: +49 221-47884541
Fax: +49 221-47884545
E-Mail: info@targos-gmbh.de
Targos
Molecular Pathology GmbH
Rudolfstr. 2
D-82166 Gräfelfing, Germany
Phone: +49 89-21112221
Fax: +49 89-21112220
E-Mail: info@targos-gmbh.de