b'S t r e a m l i n e dC D x P a r t n e r s h i p sOur Streamlined CDx program has demonstrated value, accelerating the international approvals of multiple new targeted therapies for multiple pharmaceutical companies.Product DevelopmentDesignBioinformaticsIdentify CustomComplementary Controls Software & Track Development MRD AssaysAll biomarker assaysComprehensiveMultiple NGS gene panelsCustom biomarkerComplementary MRD assays & software developedLymphoTrack Dx clonalitythat identify and trackassay development. for all biomarkerspotential under design controls. with bioinformatics software. clinically-actionablefor surrogate endpoints per biomarkers.agency inputs.ManufacturingcGMPCE-marked IVDs &AssayControls & Compliant CDx Manufacturing Development ReagentsUS FDA/CDRH PMA companion diagnosticsIUO & RUO assays, CE- DNA / RNA controls, registered, EN ISO(CDx) for US and Japan,marked IVDs, & CDx. ASRs, GPRs, MRD 13485:2016 certifiedinclusion of CDx in ARTGcontrols & proficiency manufacturing facilityAustralia and 50 CE- panels.based in San Diego. IVDs (NGS assays include bioinformatics software).Clinical Lab ServicesClinical LabInternationallyComprehensiveMOA Profiling ofWorldwide Experience Standardized Panels Novel Compounds EnrollmentA dozen years of clinicalInternationally standardizedComprehensiveUsing primary AMLTesting services have reference lab experience. CDx, flow cytometry andLymphoTrack clonality/MRDpatient samples - IC50supported hundredsbiomarker testing withassays and NGS MyGenedetermination, mRNAof enrollment sites internationally accreditedpanels identify clinically- analysis, genetic,worldwide.labs serving the US, Europe,actionable biomarkers. and phenotypic and Asia. characterization.Global Regulatory ExpertiseAccreditedRegistered MedicalMultiple CDxCE-markedMarketing & Proven Device Establishment Approvals IVDs Authorization Holder (MAH)EN ISO 13485:2016Registered Medical DeviceMultiple CDx approvals50 CE-marked accredited. ExperiencedEstablishment with the USsupporting various drugs:IVDs available in theMarketing Authorization staff & proven QualityFDA, KFDA, Saudi Arabia,by the FDA (US), PMDA/ EU and select ROWHolder (MAH) and national Management System.and the MHLW/PMDA. MHLW (Japan), and TGAmarkets; 60 testsreimbursement for CDx (Australia). CDx CE-markedincluded in the ARTGin Japan.IVD in the EU. in Australia.Invivoscribe 2021|17'