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).S t r e a m l i n e d Clinical Lab ServicesClinical LabInternationallyComprehensiveMOA Profiling ofWorldwide C D x P a r t n e r s h i p s Experience Standardized Panels Novel Compounds EnrollmentA dozen years of clinicalInternationally standardizedComprehensiveUsing primary AMLTesting services have Companion Diagnostics represents a criticalreference lab experience. CDx, flow cytometry andLymphoTrack clonality/MRDpatient samples - IC50supported hundredsmilestone in precision medicine and playsbiomarker testing withassays and NGS MyGenedetermination, mRNAof enrollment sites a pivotal role in the validation of targetedinternationally accreditedpanels identify clinically- analysis, genetic,worldwide.labs serving the US, Europe,actionable biomarkers. and phenotypic therapies. Traditional CDx developmentand Asia. characterization.models involve multiple partners adding complexity and increasing risk which couldGlobal Regulatory Expertiseaffect drug approvals.AccreditedRegistered 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.14Invivoscribe 2021|15'