Introduction LabPMM Testing Services 2 Partner with Us Successful Partnerships 4 Companion Diagnostic Tests Introduction 10 CDx - USA LeukoStrat® CDx FLT3 Mutation Assay 12 CDx - Outside of USA LeukoStrat® CDx FLT3 Mutation Assay 14 CDx - Japan LeukoStrat® CDx FLT3 Mutation Assay 16 Molecular Diagnostic Tests Introduction 18 FLT3 ITD Mutation Analysis 20 FLT3 ITD Signal Ratio Mutation Analysis 22 FLT3 TKD Mutation Analysis 24 NPM1 Mutation Analysis 26 Clonality NGS Tests Introduction 28 IGH Clonality Assays 30 IGH Somatic Hypermutation Assay 32 IGK Clonality Assay 34 TRB Clonality Assay 36 TRG Clonality Assay 38 Minimal Residual Disease NGS Tests Introduction 40 AML FLT3 ITD MRD Assay 42 NPM1 MRD Assays 44 Clonality IGH MRD Clonality Assays 46 IGK MRD Clonality Assay 48 TRB MRD Clonality Assay 50 TRG MRD Clonality Assay 52 NGS Cancer Panels Introduction 54 MyAML® 56 MyHEME® 58 MyMRD® 60 How to Order Patient Consent 62 Patient Confidentiality 63 Table of Contents The Invivoscribe wholly owned Laboratories for Personalized Molecular Medicine® (LabPMM) is a network of international reference laboratories that provide the medical and pharmaceutical communities with worldwide access to harmonized and standardized clinical testing services. We view internationally reproducible and concordant testing as a requirement for consistent stratification of patients for enrollment in clinical trials, and the foundation for establishing optimized treatment schedules linked to patient’s individual profiles. LabPMM provides consistent patient stratification at diagnosis and monitoring, as well as during the entire course of treatment in support of Personalized Molecular Medicine® and Personalized Molecular Diagnostics® . Invivoscribe currently operates three clinical laboratories and one clinical trial support office, to serve partners in the USA (San Diego, CA), Europe (Munich, Germany), and Asia (Tokyo, Japan and Shanghai, China). These laboratories use the same critical reagents and software, which are developed consistently with ISO 13485 design control. Our cGMP reagents, rigorous standards for assay development & validation, and standardized testing performed consistently with ISO 15189 requirements, help ensure LabPMM generation of standardized and concordant test results worldwide. LabPMM is an international network of PersonalMed Laboratories® focused on molecular oncology biomarker studies. LabPMM LLC Located in San Diego, California, USA. It is a CAP ISO 15189 accredited, CLIA certified, and New York State Licensed international reference laboratory. LabPMM GmbH Based in Munich, Germany. It is an ISO 15189 accredited international reference laboratory. CLIA/CAP accreditation is planned. LabPMM 合同会社 Located in Tokyo, Japan and a licensed clinical lab. Invivoscribe Diagnostic Technologies (Shanghai) Company Ltd. Located in Shangai, China. It is the newest Invivoscribe subsidiary, supporting clinical trial work in China. The following are registered trademarks of Invivoscribe, Inc.: Laboratory for Personalized Molecular Medicine® , LabPMM® , Personalized Molecular Diagnostics® , Personalized Molecular Medicine® and PersonalMed Laboratories® . LabPMM Laboratories are wholly owned subsidiaries of Invivoscribe.