b"Table of Contents Introduction 2 LabPMM Testing Services LabPMM Locations3 How to Order a Test 4Patient Consent & Confidentiality5Partner with Us6 Companion Diagnostic TestsIntroduction11 CDx - USA (FDA approved) LeukoStrat CDx FLT3 Mutation Assay12 CDx (CE-marked) LeukoStrat CDx FLT3 Mutation Assay14 CDx - Japan (MHLW/PMDA approved) LeukoStrat CDx FLT3 Mutation Assay16 Molecular Diagnostics TestsIntroduction19 NPM1 Mutation Analysis20Clonality Tests Introduction23 IGH Clonality Assays24 IGH Somatic Hypermutation Assay26 IGK Clonality Assay 28 TRB Clonality Assay30 TRG Clonality Assay32Invivoscribe's wholly-owned Laboratories for Personalized MolecularLabPMM LLC Minimal Residual Disease NGS Tests Medicine (LabPMM) is a network of international reference laboratoriesIntroduction35 that provide the medical and pharmaceutical communities with worldwideLocated in San Diego, California, USA, it holdsaccess to harmonized and standardized clinical testing services. We viewthe following accreditations and certifications:AML internationally reproducible and concordant testing as a requirement forISO 15189, CAP, and CLIA, and is licensed to provide diagnosticFLT3 ITD MRD Assay36 consistent stratification of patients for enrollment in clinical trials, and thelaboratory services in the states of California, Florida,NPM1 MRD Assays38 foundation for establishing optimized treatment schedules linked to patientsMaryland, New York, Pennsylvania, and Rhode Island.individual profile. Clonality LabPMM provides reliable patient stratification at diagnosis LabPMM GmbHIGH MRD Clonality Assays40 and monitoring, throughout the entire course of treatment in IGK MRD Clonality Assay42 support of Personalized Molecular Medicine and Personalized Based in Halbergmoos (Munich), Germany. It is an ISO 15189TRB MRD Clonality Assay44 Molecular Diagnostics. accredited international reference laboratory.TRG MRD Clonality Assay46 CLIA/CAP accreditation is planned.Invivoscribe currently operates four clinical laboratories to serve partnersNGS Cancer Panelsin the USA (San Diego, CA), Europe (Munich, Germany), and Asia (Kawasaki, Japan and Shanghai, China). These laboratories use the sameLabPMM Introduction49 critical reagents and software which are developed consistently with ISOLocated in Kawasaki (Tokyo), Japan and a licensed clinical lab.MyAML 50 13485 design control. Our cGMP reagents, rigorous standards for assay development & validation, and testing performed consistently under ISOMyMRD 52 15189 requirements help ensure LabPMM generates standardized andInvivoscribe Diagnostic TechnologiesLabPMM Assay Guidelines54 concordant test results worldwide. (Shanghai) Co., Ltd.LabPMM is an international network of PersonalMed Laboratories focusedMultiparametric Flow Cytometry Panels on molecular oncology biomarker studies. Located in Shangai, China. It is the newest internationalIntroduction57 reference lab, supporting clinical trial work in China.Hematolymphoid Screening Panel - Flow Cytometry 58 AML MRD Assay by MFC 60 LabPMM Laboratories are wholly-owned subsidiaries of Invivoscribe. The following are registered trademarks of Invivoscribe, Inc.: Laboratory for Personalized Molecular Medicine, LabPMM, Personalized Molecular Diagnostics, Personalized Molecular Medicine and PersonalMed Laboratories."