Next Generation Oncology Sequencing in your Laboratory. Built by pioneers in cancer genomics and liquid biopsy approaches PROGENEUS

Size: px

Start display at page:

Download "Next Generation Oncology Sequencing in your Laboratory. Built by pioneers in cancer genomics and liquid biopsy approaches PROGENEUS"

Silvester Robertson
5 years ago
Views:

1 PROGENEUS Next Generation Oncology Sequencing in your Laboratory Built by pioneers in cancer genomics and liquid biopsy approaches For Research Use Only. Not for iagnostic Purposes.

2 personalgenome.com/progeneus A comprehensive solution for in-house NGS testing and analysis PROGENEUS enables your research laboratory to build a comprehensive, customized NGS offering using the most sensitive and specific methods for identifying and analyzing sequence mutations and structural alterations. As NGS cancer testing becomes more widely adopted, laboratories seek to build their own high quality solution with off-the-shelf components. PROGENEUS facilitates the process to build a high quality testing solution by packaging a comprehensive suite of cancer NGS components including: Standard or customized tissue and plasma panels Variantx, an exquisitely sensitive and specific somatic alteration detection software package Proven laboratory methods and training Verification samples to enable rapid assay set-up Bioinformatics servers housed in your laboratory Live customer support and access to expert resources Unsurpassed limit of detection For tissue biopsies, PROGENEUS detects mutations below 5% mutation allele frequency (MAF) with high sensitivity, enabling labs using PROGENEUS to identify up to 20% more mutations than competing methods. For liquid biopsies, it can detect both mutations and translocations reliably down to 0.1% circulating tumor NA levels (ctna). More sensitive than traditional PCR-based tissue testing for low tumor purity samples Our proprietary target enrichment methods enable quantification of unique reads at any given position (distinct coverage) to accurately identify mutations from low tumor purity samples. PCR-based methods measure total coverage but not distinct coverage. The inability to calculate distinct coverage may compromise assay sensitivity and specificity, particularly when MAF is <20% which is typical with the low tumor purity samples common in some tumor types (e.g. NSCLC). More comprehensive than PCR-based tissue testing CancerPRO Tissue and Plasma panels detect sequence mutations, indels, copy number amplification, and translocations without requiring co-extraction of RNA to detect fusions. Flexible sample types with limited material PROGENEUS accommodates tissue (frozen or FFPE), NA, saliva, whole blood, and plasma. For tissue biopsies, NGS testing can be completed using as little as 50ng ( 20% tumor purity) of NA. For liquid biopsies, minimum NA input is just 10 ng or as little as 1 ml of plasma collected in ETA or Streck tubes. Allows for tumor only or tumor/ normal testing approaches PROGENEUS is also the only solution that allows for analysis of a tumor to a matched normal sample, reducing the incidence of germline mutations reported as candidate somatic mutations. Unsurpassed number of true calls used to optimize Variantx, our bioinformatics pipeline Variantx is the only bioinformatics pipeline validated and optimized against hundreds of millions of Sanger sequenced matched tumor/ normal base pair calls and over 10,000 fusion events delivering the lowest false positive rate and most accurate germline filter for NGS cancer testing. Cost-effective implementation For labs that aspire to run high-quality NGS testing with minimal R& investment, and interrogate all forms of oncogenic alterations, PROGENEUS provides the only fully supported and comprehensive platform solution. For Research Use Only. Not for iagnostic Purposes.

Operational NGS kit with full support by a world-class team of experts Flexible testing panels Pre-designed pan-cancer or targeted gene panels can be implemented and verified in your laboratory in as

3 Operational NGS kit with full support by a world-class team of experts Flexible testing panels Pre-designed pan-cancer or targeted gene panels can be implemented and verified in your laboratory in as little as 12 weeks. Customized panels can be developed while collaborating with PGx experts in 2-3 months. Reagent kits PGx supplies all the key reagents required to prepare genomic libraries for sequencing from extracted NA on Illumina s MiSeq and HiSeq NGS systems. On-site server An optional on-site server houses Variantx to ensure ownership and security of valuable sample data. Flexible data formats Sequencing data and analysis integration for customized reporting using XML or tab-delimited formats. Web-based portal Training and other PROGENEUS support tools accessible from a web-based portal tailored to your laboratory s set-up. On-site training Hands-on training can be conducted on-site or at the PGx laboratory to build proficiency with our methods. Verification support Optional verification samples provided for well characterized mutations in both FFPE and ctna formats. Live customer service Live customer support is available by phone or connecting you to experts that can assist across every stage in the testing and analysis workflow. NGS LAB SET-UP IN AS LITTLE AS 12 WEEKS 12 weeks NGS LAB TESTING WITH A 1-2 WEEK TURNAROUN 1-2 weeks Rapid set-up on Illumina MiSeq or HiSeq platforms Installation of bioinformatics server at your site Training available For Research Use Only. Not for iagnostic Purposes. Turnaround time cut in half (when compared to send out testing)

4 Addressing the needs and obstacles to in-house NGS testing Early adopters of genomics testing that have internalized processes within their own workflow cited various issues and barriers to successfully implementing NGS when polled by independent researchers*. PROGENEUS addresses or mitigates all of the stated barriers and needs. Reported barriers to implementing NGS Scarcity of Expense of implementation informatics expertise Rapidly changing Amount of data to curate nature of technology ifficulty of deploying first test Verification of testing protocols Lack of on-the-job training resources Unanticipated needs Additional on-the-job training Training of pathologists and scientists Staff development and professional expertise Comprehensive offering Customizable gene panels for multiple sample types Precise NGS results with both high sensitivity and specificity Verification samples for quality control and proficiency testing purposes Proven bioinformatics pipeline and customizable reporting Rapid implementation Low up-front costs On-site technology platform from sample processing through data analysis In-person training and dedicated resource portal edicated technical support and live expert resources *The business of genomic testing: a survey of early adopters. Genetics in Medicine (2014) 16,

5 CAPTURE-BASE APPROACH FOR COMPREHENSIVE ETECTION OF IMPORTANT ALTERATIONS SEQUENCE MUTATIONS MICRO-SATELLITE INSTABILITY AMPLIFICATIONS GENOMIC REARRANGEMENTS For Research Use Only. Not for iagnostic Purposes.

6 FAST AFFORABLE FLEXIBLE Implemented in your lab in as little as 12 weeks Minimal laboratory and bioinformatics R& investment Pre-designed and custom panels Tissue or plasma Matched normal option (tissue) Learn more at PERSONALGENOME.COM/PROGENEUS For more information or to download detailed information on the platform, visit us online or contact PGx to set up a meeting PERSONALGENOME.COM/PROGENEUS For Research Use Only. Not for iagnostic Purposes. 10/2015 ES-002-V1

CAPTURE-BASED APPROACH FOR COMPREHENSIVE DETECTION OF IMPORTANT ALTERATIONS

CAPTURE-BASED APPROACH FOR COMPREHENSIVE DETECTION OF IMPORTANT ALTERATIONS CAPTURE-BASE APPROACH FOR COMPREHENSIVE ETECTION OF IMPORTANT ALTERATIONS SEQUENCE MUTATIONS MICROSATELLITE INSTABILITY AMPLIFICATIONS GENOMIC REARRANGEMENTS For Research Use Only. Not for iagnostic Purposes.