targos efficient·reliable·flexible€¦ · as next-generation sequencing, ... genomics-based...

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In Business forPersonalized 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

ProjectManagers

ResultsReporting

&QualityControl

Pharma and Clinical

Sites

LogisticsLogistics

StudyOffice

Pathologists

Laboratory

Storage andArchiving

Pathology Services

Central LaboratoryServices

Consulting andTraining

AssayDevelopment

Clinical TrialConsulting

Molecular BiologyTissue Repository

Storage & Archiving

Customized Assays

ClinicalStudies

DirectorService 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

BiomarkerResearch &Discovery

BiomarkerValidation

AssayDevelopment

Assay Validation

ClinicalUtilityTesting

RegulatoryApproval(limited

involvement)

Manufacturing(no involvement)

Marketing

BiomarkerResearch &Discovery

BiomarkerValidation

AssayDevelopment

Assay Validation

ClinicalUtilitytesting

RegulatoryApproval(limited

involvement)

Manufacturing(no involvement)

Marketing

TargosMolecularPathology




TargosAdvance

Currently noInvolvement

TargosAdvance

PathologyNordhessenA TargospartnerCompany


TargosDevelopment

- IHC- FISH- PCR

- Europe- Middle-East

Approval Process

CDx Market

Training & Consulting- On Site

- Custom

- Academia- Industry- International

ReferenceTesting

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

THE INFORMATION IN THIS DOCUMENT IS PROVIDED “AS IS” WITHOUT ANY WARRANTY, EXPRESS OR IMPLIED, INCLUDING WITHOUT ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND ANY WARRANTY OR CONDITION OF NON-INFRINGEMENT.

Trademarked terms are marked on their first occurrence in this information with a trademark symbol (® or ™), these symbols indicate U.S. registered or common law trademarks owned by companies at the time this information was published.

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 AKESOgenTargos 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 [email protected] for more information about our Clinical Trial Services in the U.S.

Services Offered in China in Collaboration with WuXi AppTecTargos 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 ServicesFull 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 [email protected] 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 companies 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: [email protected]

Targos Inc.24506 SE 45th Way

Issaquah, WA, 98029. U.S.A.


TargosMolecular Pathology GmbH

Germaniastrasse 7

D-34119 Kassel, Germany

Phone: +49 561-50045299

Fax: +49 561-50045355


Germany:


Gleueler Str. 176-178

D-50935 Köln, Germany

Phone: +49 221-47884541

Fax: +49 221-47884545



Rudolfstr. 2

D-82166 Gräfelfing, Germany

Phone: +49 89-21112221

Fax: +49 89-21112220


targos efficient·reliable·flexible€¦ · as next-generation sequencing, ... genomics-based...

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