b"Table of ContentsIntroductionLabPMM Testing Services2How to OrderPatient Consent4Patient Confidentiality5 Partner with UsSuccessful Partnerships6Companion Diagnostic TestsIntroduction12CDx - USALeukoStrat CDx FLT3 Mutation Assay 14 CDx(CE-marked)LeukoStrat CDx FLT3 Mutation Assay16CDx - JapanLeukoStrat CDx FLT3 Mutation Assay18Molecular Diagnostic TestsIntroduction20NPM1 Mutation Analysis22Invivoscribe's wholly-owned Laboratories for Personalized MolecularClonality NGS Tests LabPMM LLCMedicine(LabPMM) is a network of international reference laboratoriesIntroduction24that 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:IGH Clonality Assays26internationally reproducible and concordant testing as a requirement forISO 15189, CAP, and CLIA, and is licensed toIGH Somatic Hypermutation Assay28consistent stratification of patients for enrollment in clinical trials, and theprovide diagnostic laboratory services in theIGK Clonality Assay30foundation for establishing optimized treatment schedules linked to patientsstates of California, Florida, Maryland, New York,TRB Clonality Assay32individual profile. Pennsylvania, and Rhode Island. TRG Clonality Assay34LabPMM provides reliable patient stratification at diagnosis Minimal Residual Disease NGS Testsand monitoring, throughout the entire course of treatment in LabPMM GmbH support of Personalized Molecular Medicine and PersonalizedMolecular Diagnostics. Based in Munich, Germany. It is an ISO 15189Introduction 36accredited international reference laboratory. Invivoscribe currently operates three clinical laboratories and one clinicalCLIA/CAP accreditation is planned. AML trial support office to serve partners in the USA (San Diego, CA), EuropeFLT3ITD MRD Assay38(Munich, Germany), and Asia (Tokyo, Japan and Shanghai, China).NPM1 MRD Assays40These laboratories use the same critical reagents and software whichLabPMMare developed consistently with ISO 13485 design control. Our cGMPLocated in Tokyo, Japan and a licensed clinical lab.Clonalityreagents, rigorous standards for assay development & validation, andIGH MRD Clonality Assays42testing performed consistently under ISO 15189 requirements help ensureIGK MRD Clonality Assay44LabPMM generate standardized and concordant test results worldwide. Invivoscribe DiagnosticTRB MRD Clonality Assay46LabPMM is an international network of PersonalMed Laboratories focusedTechnologies (Shanghai) Co., Ltd. TRG MRD Clonality Assay48on molecular oncology biomarker studies. NGS Cancer PanelsLocated in Shangai, China. It is the newest Invivoscribe subsidiary, supporting clinical trial workIntroduction50in China.MyAML52LabPMM Laboratories are wholly-owned subsidiaries of Invivoscribe. MyHEME56MyMRD54The following are registered trademarks of Invivoscribe, Inc.: Laboratory for Personalized Molecular Medicine, LabPMM, Personalized Molecular Diagnostics, Personalized Molecular Medicine and PersonalMed Laboratories."