b'An Ideal CDx Partner Partnerfor Drug Approvals with UsIVD Product DevelopmentOver 25 years of assay development experience Biomarker assays & software development under full ISO 13485 design controls Comprehensive NGS gene panels that identify actionable biomarkers Custom biomarker assay and CDx developmentGlobal Regulatory, Quality and Commercial ExpertiseExperienced staff & proven Quality Management System Full adherence to FDA 21 CFR part 820 and ISO13485 standards Registered Medical Device Establishment with the US FDA, KFDA, Saudi Arabia, and the PMDA Multiple CDx approvals supporting various drugs: by the FDA (US), PMDA/MHLW (Japan), and TGA (Australia).CDx CE-marks in the EU 50+ CE-marked IVDsavailable in the EU and select ROW markets;60 tests registered with the ARTG in Australia Marketing Authorization Holder (MAH) and National reimbursement for CDx in Japan. CDx submitted for reimbursementin the US Supporting ongoing clinical drug trials in the US, EU, Japan, China and ROW.Clinical TestingGlobal Clinical Reference Laboratory NetworkA dozen years of clinical reference lab experience Internationally standardized CDx and biomarker testing with labs serving the US, Europe, and Asia Comprehensive LymphoTrack clonality/MRD assays and CAP and CLIA-certified NGS MyGene panels identify clinicallyactionable biomarkers Complementary MRD assays for all biomarkerspotential for surrogate endpoints per agency inputsTesting services have supported hundreds of enrollment sites worldwideManufacturingFDA/CDRH-registered and ISO 13485-certified cGMP manufacturing facility based in San Diego Comprehensive Dx and CDx Manufacturing CDx for USA (PMA), Japan, EU, Australia, and ROW markets50+ CE-IVDs (NGS assays + bioinformatics software) IUO & RUO assays, ASRs & GPRsDNA / RNA controls, MRD controls & proficiency panels LabPMM Services Catalog 2021|7'