Targos Efficient Reliable Flexible

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1 Targos Efficient Reliable Flexible In Business for Personalized Healthcare Targos Molecular Pathology Clinical Biomarker Services Targos Advance Training & Consulting Targos Development Biomarker R&D 1

2 Targos Offers Global Services About Targos USA: Issaquah USA: Atlanta Germany: Kassel Cologne Munich USA: San Bruno China: Shanghai Targos Facility in Kassel, Germany In Business for Precision Medicine - Since 1999 Professional Accreditations Targos Molecular Pathology is accredited by the Targos Molecular Pathology GmbH is accredited Commission on Laboratory Accreditation of the by the Clinical Laboratory Improvement Amendments Program (CLIA) College of American Pathologists (CAP) Targos is audited annually since 2005 by FDA, Pharma PDQA and Biotech QA Targos is a leader in clinical biomarker services. Targos laboratories provide a unique comprehensive 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 managers, logistical personal and quality assurance experts, the company is well positioned to manage the increasing demand from pharmaceutical companies for all surgical pathology and molecular biology work. The organization provides a global CAP/CLIA/GLP quality capability 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: , 2005; Lancet. 2010; 376: ), 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 differences between breast and gastric cancer. 2 3

3 Global Clinical Trial Services Targos Laboratories Targos has screened more than 100,000 patients pathologists, project management through PhD Dedicated team of scientists offer assay esta- Discovery of biomarkers include prevalence as part of its clinical trial services. The company trained managers, logistics (e.g., sample kits, blishment and validation of biomarkers according analyses based on IHC/ISH, investigation of has acted as a GCP compliant patho-diagnostic sample pick-up, re-shipment, storage, archiving), to ICH, USCAP & CLIA guidelines. We further phosphorylated proteins, the generation of tissue reference center for more than 100 diagnostic tri- data/quality management, assay development, assist in the approval and marketing process of in microarrays or nucleic acid based tests such as als for international Pharmaceutical and biotech consulting and training according to full GCP vitro diagnostics by providing the required docu- next-generation sequencing, PCR based mutation companies. International customers and the US standards. We also serve all phases of biomarker mentation for submission to regulatory agencies, analysis or RNA expression profiling. Food and Drug Administration (FDA) have regu- development from phase I-IV clinical trials. conducting clinical trials for IVD and/or drug larly audited our projects and facilities. Targos approval as well as the organization of end-user Molecular Pathology supports global clinical trials Our pharma customers and the FDA training in our training facility at Targos. with pathology services through board certified regularly audit Targos. Pharma and Clinical Sites Consulting and Training Molecular Biology Tissue Repository Storage & Archiving Immunohistochemistry Full Service Provider All Tissue Based Biomarkers Logistics Logistics In Situ Hybridization DNA-ISH (FISH, DDISH,CISH) RNA-ISH Storage and Archiving Results Reporting & Quality Control Project Managers Pathologists Laboratory Study Office Pathology Services Assay Development Customized Assays Director Service Operations Central Laboratory Services Clinical Trial Consulting Clinical Studies Immunofluorescence ELISA Tissue Microarray Multiplexing Services for Tissues and Cells Detection of Biomarkers Quantitative Determination of Serum HER-2/neu Customized Assays for Detection of Target Protein Phosphorylation 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 Our clinical trial services include Biomarker driven clinical trials for drug and/or IVD approval under GCP regulatory compliant conditions 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 embedded 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. Macro & Microdissection qrt-pcr Mutation Analysis Expression Profiling Next Generation Sequencing On Formalin Fixed Tissues to Enrich for Tumor Microdissection undertaken by Board-Certified Pathologists Simultaneous Amplification and Quantitation of Targeted DNA Gene-Expression Profiling Extraction of Genomic DNA from Fresh or FFPE Tissues Mutation call by qpcr using Mutation Specific Primers Affymetrix and NanoString Technologies Bioinformatic Analysis and the Delivery of a Scientific Report Targeted Deep Sequencing Development of Proprietary Assays for Big Pharma 4 5

4 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 - On Site - Custom Training & Consulting CDx Market Reference Testing - IHC - FISH - PCR Approval Process 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 - Academia - Industry - International Ring Studies Quality Assurance - Europe - Middle-East 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 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 ). 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 Prof. Büttner is an internationally recognized expert in mutation testing in lung cancer (Nat Genet 44: :2012), lung cancer genomics (J Clin Oncol 31: : 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. 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. 6 7

5 Targos Education Programs Services offered in the U.S. & China Education Programs in the U.S. and Canada ACCME Accredited Pathology Education NSH Certified Educational Units Short-Course Three-day Course 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: Predictive Biomarkers: Lessons from Clinical Trials Conducted through United States and Canadian Academy of Pathology (USCAP) in situ hybridization, Microarrays and NextGeneration Sequencing Conducted through National Society for Histotechnology (NSH) Next Generation Sequencing Epigenomics Full Service Provider Consulting & Experimental design Bioinformatics Support Whole Genome Methylation Profiling Bisulpite Treatment and Assays for FFPE Material Bioinformatics Support Education Programs in Germany Genotyping Custom Based Services Whole Genome SNP Analysis Whole Genome Copy Number Variation 1-3 Day International Biomarker Training Courses for Pathologists and Oncologists 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 Preceptorship Meetings in Pathology In collaboration with pharmaceutical companies and thought leaders, Targos provides preceptorship opportunities to the continued training of new clinicians within their clinical practice 1-2 Week Practical Training Courses for Medical Technologists In collaboration with German Institute for Training for Technologists, Berlin, Germany. DNA-RNA Extractions Gene Expression Analysis Bioinformatics & Biostatistics FFPE, Frozen Tissue and Biopsy Material, Cell Cultures Urine, Whole Blood, Stool, Saliva, Blood Cards Buccal Scrapes / Swabs and Mouthwash Samples RNA Seq and Transcriptome (NGS) Microarray Services (Affymetrix and Illumina) qpcr 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) Lung cancer pathology and correlation to clinical oncology In Situ Hybridization Microarray Services Next-Generation Sequencing HER2 FISH Testing Full Spectrum Microarray Services Gene Expression, Copy Number and Cytogenetics GWAS and Genotyping 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. 8 9

6 Impressions of Targos Impressions of Targos Visit us at:

7 Germany: Targos Molecular Pathology GmbH Germaniastrasse 7 D Kassel, Germany Phone: Fax: Targos Molecular Pathology GmbH Gleueler Str D Köln, Germany Phone: Fax: Targos Molecular Pathology GmbH Rudolfstr. 2 D Gräfelfing, Germany Phone: Fax: United States: Targos Inc Bayhill Drive, 2nd Floor, San Bruno, CA, U.S.A. Phone: (Direct Line) Phone: (Reception) Fax: Targos Inc SE 45th Way Issaquah, WA, U.S.A. 12