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It outlines intended use, theory of operation, run plan creation, sample and library/template preparation, sequencing, data analysis, results, contraindications, and key warnings. It also specifies pass/fail quality control criteria, retest strategies, variant reporting logic, and details appendix performance characteristics including analytical accuracy, LoB/LoD, precision, stability, and interference/carryover studies.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/oncomine-dx-express-test-part-i-user-guide-test-description-and-performance-characteristics/449542/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/oncomine-dx-express-test-part-i-user-guide-test-description-and-performance-characteristics/449542.png","ImageObject",300,407,{"name":92,"@type":93},"pixelkiddo","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-11-05","2026-09-30",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",14,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"What systems and software are listed for use with the Oncomine™ Dx Express Test Part I guide?","Question",{"text":113,"@type":114},"The guide specifies use with the Genexus™ Dx Purification System, Genexus™ Dx Integrated Sequencer, and Genexus™ Dx Software 6.8.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"What does CHAPTER 1 cover in this user guide?",{"text":118,"@type":114},"CHAPTER 1 includes product information such as intended use, theory of operation, run plan creation, sample/library/template preparation, sequencing, data analysis, results, contraindications, and assay warnings and limitations.",{"name":120,"@type":111,"acceptedAnswer":121},"What is included in CHAPTER 2 regarding pass/fail outcomes?",{"text":122,"@type":114},"CHAPTER 2 provides quality control pass/fail criteria, the retest strategy, quality control logic and variant reporting, and guidance for variant call filters and No Call repeat strategies.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},449542,1791190209,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":140,"language":141,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":142,"faqs":143,"seo_title":144,"seo_description":67,"update_tm":145,"read_time":146,"preview_page_count":4},962090883892,"https://ap-avatar.wpscdn.com/avatar/e00115db34f3e0f11b?x-image-process=image/resize,m_fixed,w_180,h_180&k=1790152879550218658","Oncomine ™ Dx Express Test Part I: Test Description and Performance Characteristics  \nUSER GUIDE  \nfor use with:  \nGenexus ™ Dx Purification System Genexus ™ Dx Integrated Sequencer Genexus ™ Dx Software 6.8  \nPublication Number MAN1001774  \nRevision A  \nFor In Vitro Diagnostic Use. | Rx Only  \nLife Technologies Holdings Pte Ltd | Block 33 |  \nMarsiling Industrial Estate Road 3 |\\#07-06, Singapore 739256  \nLife Technologies Corporation | 7335 Executive Way | Frederick, Maryland 21704 USA  \nProducts manufactured at this site:  \n• Genexus™ Dx Purification System  \n• Genexus™ Dx Integrated Sequencer  \n• Genexus™ Dx Software  \nProducts manufactured at this site:  \n• Oncomine™ Dx Express Test  \n• Oncomine™ Dx Express Test FFPE DNA and RNA Control Kit  \n• Genexus™ Dx FFPE DNA/RNA Purification Combo Kit  \n• Genexus™ Dx Library Strips 1 and 2‑HD  \n• Genexus™ Dx Templating Strips 3‑GX5™ and 4  \n• Genexus™ Dx Sequencing Kit  \n• Genexus™ Dx Barcodes 1–32 HD  \n• Genexus™ Dx GX5™ Chip and Genexus™ Coupler  \n• Genexus™ Dx Pipette Tips  \n• Genexus™ Dx Filter  \n• Genexus™ Dx Conical Bottles  \nFor descriptions of symbols on product labels or product documents, [go to](go to thermofisher.com/symbols-definition)[ thermofisher.com/symbols-definition](go to thermofisher.com/symbols-definition). Revision history: MAN1001774 A (English)  \n\n| Revision | Date | Description |\n| --- | --- | --- |\n| A | 9 September 2026 | New IVD user guide for the Oncomine™ Dx Express Test for FDA submission. |\n\nThe information in this guide is subject to change without notice.  \nDISCLAIMER: TO THE EXTENT ALLOWED BY LAW, THERMO FISHER SCIENTIFIC INC. AND/OR ITS AFFILIATE(S) WILL NOT BE LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE, OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF THE DOCUMENT OR THE PRODUCT.  \nTrademarks: All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. Google Chrome is a trademark of Google Inc. ZEGFROVY is a trademark of Dizal (Jiangsu) Pharmaceutical Co. , Ltd. Eppendorf and LoBind are trademarks of Eppendorf SE. HYRNUO is a registered trademark of Bayer AG.  \n©2026 Thermo Fisher Scientific Inc. All rights reserved.  \nContents  \nAbout this guide ........................................................... 5  \nPurpose of this guide ............................................................ 5  \nOncomine™ Dx Express Test user guides ........................................... 5  \n■ CHAPTER 1 Product information .................................................. 6  \nOncomine™ Dx Express Test ...................................................... 6  \nIntended use ................................................................... 6  \nTheory of operation .............................................................. 7  \nOverview .................................................................. 7  \nRun plan creation ........................................................... 7  \nSample preparation ......................................................... 8  \nLibrary preparation .......................................................... 8  \nTemplate preparation ........................................................ 8  \nSequencing ................................................................ 9  \nData analysis ............................................................... 9  \nResults .................................................................... 9  \nContraindications .............................................................. 10  \nAssay warnings and limitations .................................................. 10  \nGenexus™ Dx Integrated Sequencer hardware configuration ......................... 12  \nSoftware compatibility and requirements .......................................... 12  \nOncomine™ Dx Express Test panel, controls, purification and sequencing reagents, and supplies ...........................................","cbCaigs6pnOzAV4Y","https://ap.wps.com/l/cbCaigs6pnOzAV4Y","pdf",48633376,1665,"English","# About this guide\n## Purpose of this guide\n## Oncomine™ Dx Express Test user guides\n# CHAPTER 1 Product information\n## Oncomine™ Dx Express Test\n## Intended use\n## Theory of operation\n## Overview\n## Run plan creation\n## Sample preparation\n## Library preparation\n## Template preparation\n## Sequencing\n## Data analysis\n## Results\n## Contraindications\n## Assay warnings and limitations\n## Genexus™ Dx Integrated Sequencer hardware configuration\n## Software compatibility and requirements\n## Oncomine™ Dx Express Test panel, controls, purification and sequencing reagents, and supplies\n# CHAPTER 2 Pass/fail criteria and repeat strategy\n## Quality control pass/fail criteria\n## Retest strategy\n## Quality control logic and variant reporting\n## Variant call filters and No Call repeat strategies\n# APPENDIX A Performance characteristics\n## Analytical studies\n## Analytical accuracy studies\n## Limit of Blank (LoB) study\n## Limit of Detection studies\n## Nucleic acid input studies\n## Tissue input study\n## Tumor content study\n## Interfering substances studies\n## Tumor necrosis study\n## Carryover and cross-contamination study\n## Primer specificity—in silico analysis study\n## Precision studies\n## Stability of assay intermediates study\n## FFPE tissue block, curl, and slide stability study\n## Extracted nucleic acid stability study\n## Reagent stability study","[{\"question\":\"What systems and software are listed for use with the Oncomine™ Dx Express Test Part I guide?\",\"answer\":\"The guide specifies use with the Genexus™ Dx Purification System, Genexus™ Dx Integrated Sequencer, and Genexus™ Dx Software 6.8.\"},{\"question\":\"What does CHAPTER 1 cover in this user guide?\",\"answer\":\"CHAPTER 1 includes product information such as intended use, theory of operation, run plan creation, sample/library/template preparation, sequencing, data analysis, results, contraindications, and assay warnings and limitations.\"},{\"question\":\"What is included in CHAPTER 2 regarding pass/fail outcomes?\",\"answer\":\"CHAPTER 2 provides quality control pass/fail criteria, the retest strategy, quality control logic and variant reporting, and guidance for variant call filters and No Call repeat strategies.\"}]","Oncomine™ Dx Express Test Part I - User Guide - Test Description and Performance Characteristics | PDF",1790730529,4196]