DNA. Clinical Trials. Research RNA. Custom. Reports CLIA CAP GCP. Tumor Genomic Profiling Services for Clinical Trials

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1 Tumor Genomic Profiling Services for Clinical Trials Custom Reports DNA RNA Focused Gene Sets Clinical Trials Accuracy and Content Enhanced NGS Sequencing Extended Panel, Exomes, Transcriptomes Research Validated CLIA CAP GCP Comprehensive Reports Optimized Bioinformatics GENOME4 ( )

2 Personalis, Inc. Tumor Genomic Profiling Services for Clinical Trials Thank you for taking the time to familiarize yourself with Personalis capabilities. We have invested heavily in developing the highest quality genomic testing services for oncology clinical trials. By bringing together expertise in all aspects of tumor profiling, we strive to improve all stages of the process to deliver a superior result. This begins with a deep understanding of human genome structure and variation, along with expertise in cancer genomics, and extends through optimized sample prep methodologies, dedicated cancer bioinformatics, and the highest quality clinical laboratory operations. We built our clinical trials services from the ground up, to ensure that we produce the broadest and most accurate data set for every sample, and then tailor the results to fit your needs. We strive to be flexible, timely, and to provide you the best results possible. We hope that once you become familiar with the level of service we deliver, you will give us the opportunity to provide you with the best genomic sequencing and analysis possible for your clinical trials. Sincerely, John West CEO, Personalis Personalis Fast Facts Founded in ,000 square foot facility with state-of-the art clinical laboratory in Menlo Park, CA CLIA Licensed/CAP Accredited Management and scientific team with over a decade of experience in next generation sequencing laboratory technology and bioinformatics, including work for many of the world s top pharmaceutical companies One of the largest commercial providers of genome and exome sequence data in the world Provides cancer genomic services for clinical trials to many of the top global pharma companies 2

3 Comprehensive Coverage, Tailored Results Tumor Genomic Profiling Services for Clinical Trials Comprehensive Coverage, Tailored Results Comprehensive and Accurate DNA and RNA sequencing and analysis of your tumor samples We have designed our accuracy and content enhanced platform (ACE) for tumor profiling to provide the most complete genomic data from any tumor sample type. Our cancer panel includes coverage of over 1300 genes, including clinically actionable genes, known driver mutations, immuno-oncology and key cancer pathway genes. We perform both DNA and RNA analysis from a single sample, providing deep coverage for detection of rare somatic variants, known and novel fusion transcripts, and expression data. Our service is tailored to serve the needs of your clinical trial enrollment requirements while simultaneously making a broader research dataset available. As a result, we maximize the return on every tumor sample. TABLE 1: Example of the number of genes included in commercially available panels. Pathways Panel 1 Panel 2 Panel 3 ACE Extended Cancer Panel Notch % P13K-Akt % P % TGF-beta % MAPK % JAK-STAT % Apoptosis % Cell cycle % Transcriptional misregulation Difference % mirna % Tailored service to meet your specific requirements We know information needs change based on the design and the phase of the clinical trial. We can perform tumor analysis from a variety of sample types including FFPE and fresh frozen tissue. From our comprehensive cancer panel, we can provide both a focused clinical report for your genes/variants of interest and a set of comprehensive research reports detailing all SNVs, indels, CNAs and fusions detected, as well as gene expression data. In addition we can provide the raw data files to support your ongoing research needs. Validated processes that meet the highest quality and regulatory standards We have a rigorous focus on accuracy, quality, data security and traceability. We have built processes into our clinical laboratory that go beyond the licensing and accreditation requirements of CLIA and CAP. The highest standards of quality are met through a rigorous, comprehensive, and integrated quality system that includes assays development, validation, process documentation, staff training and competency assessments. Pioneering Genome-Guided Medicine 3

4 Personalis, Inc. Tumor Genomic Profiling Services for Clinical Trials Complete and accurate genomic profiles of your tumor samples. Tailored reporting for your clinical trial. Personalis portfolio of cancer products for clinical trials is based on several foundational innovations that span sample prep, sequencing, analysis and reporting steps to provide the most comprehensive characterization of your tumor sample. The combination of innovations across the workflow makes it the most advanced service designed for clinical trials of targeted therapeutics as well as biomarker research. Personalis ACE Cancer DNA and RNA panel for clinical trials is based on our Accuracy and Content Enhanced (ACE) Technology. With this technology, the accuracy of our ACE Cancer Panel has been enhanced over standard NGS panel approaches by augmenting and repairing coverage gaps, especially in targeted regions with high-gc content. This results in genes with more accurate and complete coverage. The content of our cancer panel has been carefully chosen by cancer genomics experts* and interrogates both DNA and RNA from a single sample to provide a comprehensive view of your tumor sample. Personalis state-of-the-art informatics and analysis pipelines have been developed and optimized specifically for tumor analysis. All classes of variants, including SNV, indels, CNVs and fusion events, are reportable. The Personalis annotation engine combines and integrates over 40 different public and proprietary databases, which are manually curated and kept current. This detailed analysis is followed by our tailored reporting capabilities that are based on your study design and stage of your clinical trial. For clinical research purposes, Personalis additionally offers the Personalis ACE Exome for Cancer Research and the Personalis Whole Transcriptome for Cancer Research. The ACE Exome is an accuracy and content enhanced whole exome analysis, with ~8,000 biomedical genes enhanced, including enhanced coverage of more than 1,300 cancer genes and is ideal for research applications. The exome analysis can be paired with an RNA analysis on the same sample using high depth whole transcriptome sequencing to identify novel gene fusion events. What Differentiates Us Prep and Sequencing Normal DNA Extended Cancer Panel DNA SNVs Cancer Exome Annotation Interpretation 5 10 Public Databases DNA Reports 40 Public + Proprietary Databases DNA Reports, RNA Reports, Custom Reports Indels Copy Number Alterations SNVs Indels Alignment MORE COMPREHENSIVE Tumor DNA MORE ACCURACY ACE Cancer Services Small Cancer Panel Alignment Tumor DNA Typical Service Informatics Tumor RNA Extended Cancer Panel RNA Cancer Transcriptome Copy Number Alterations Fusions Gene Expression Raw Data Delivered Improved Sample Prep High Accuracy ACE Assays Validated Assays Validated Informatics Curated Databases ACE extended cancer panel includes a core set of clinically actionable genes, all genes in the Cancer Gene Census, genes from TCGA reports, and those within canonical cancer pathways proposed by Vogelstein et. al. (Science, March 29, 2013) and other leading academic groups, as well as an additional 200 cancer related micro RNA genes and important pharmacogenomics genes 4

5 Complete and Accurate Genomic Profiles Sample Types FFPE Fresh Frozen Tissue DNA RNA For cancer projects, many studies utilize tissue archives that have been fixed using FFPE procedures. FFPE induces protein protein and protein nucleic acid crosslinking, making it difficult to separate DNA from histones and to obtain a pure sample. This process can also lead to DNA fragmentation. Personalis scientists have optimized extraction methodologies for challenging cancer samples to achieve successful results. In addition to FFPE samples we also accept fresh frozen tissue, blood, DNA and RNA samples. Features >1,300 cancer genes plus >200 mirna genes for DNA analysis RNA transcripts from >1,300 cancer genes for RNA analysis Augmented for accuracy with ACE technology Comprehensive coverage of key cancer pathway genes >500x mean coverage over the extended footprint (DNA) Sensitivity for both known and novel fusion events (RNA) Complete informatics analysis Alterations reported include SNVs, CNVs, gene fusions and low-level variant expression Most accurate and extensive variant annotation with 40 public and proprietary databases Flexible reporting capabilities allow the analysis of the complete panel or a focused set of genes based on your requirements. Pioneering Genome-Guided Medicine 5

6 Personalis, Inc. Validated Process Validated process that meets the highest quality and regulatory standards We have built processes into our clinical laboratory that go beyond the licensing and accreditation requirements of CLIA and CAP. The highest standards of quality are met through a rigorous, comprehensive, and integrated quality system that includes assays development, validation, process documentation and staff training. The accuracy of our assays is captured through a comprehensive validation process resulting in method performance specifications and extensive documentation (inclusive of measurements for all mandated assay metrics). Our quality management and quality control program is compliant with CLIA / CAP-accredited regulatory requirements and includes proficiency testing. Software, instrumentation and reagents are an integral part of our system quality plan, thus providing the necessary infrastructure and framework for quality, safety and traceability. Our step-by-step comprehensive and version controlled procedures manual assures proper implementation of approved procedures by well-trained staff. 6

7 Pioneering Genome-Guided Medicine 7

8 Tumor Genomic Profiling for Clinical Trials Comprehensive Coverage Tailored Results Personalis, Inc O Brien Drive Menlo Park, CA GENOME4 ( ) info@personalis.com LEARN MORE To learn more about the ACE Services for Cancer, please visit or contact your local Personalis representative. SALES CONTACT United States: info@personalis.com Europe: europe@personalis.com Other Countries: info@personalis.com 2015 Personalis, Inc. All rights reserved. Personalis, ACE Exome, ACE Clinical Exome, and ACE Genome are registered trademarks or trademarks of Personalis, Inc., ( Personalis ) in the United States and/or other countries B