b'Partner with Us Partner with UsAn Ideal CDx Partner for Drug ApprovalsContact us for more information: businessdevelopment@invivoscribe.comYour Ideal Partner for Laboratory Services, Clinical Trial Testing, and Companion Diagnostic DevelopmentLabPMM (an Invivoscribe company) is your partner of choice for diagnostic, research, and clinical trial services.Our network of laboratories located in the USA, Europe and Asia specialize in internationally harmonized molecular testing,IVD Product Developmentand collectively have CLIA and ISO 15189 certifications via CAP and DAkkS. We also offer contract research organizationClinical Testing (CRO) services, and are a comprehensive companion diagnostics (CDx) partner, providing ISO 13485-compliant biomarker25 years of assay development experienceGlobal Clinical Reference Laboratory Networkdevelopment, cGMP manufacturing, regulatory capability, global laboratory services and commercialization. Biomarker assays & software development under full ISOA dozen years of clinical reference lab experience We offer an ever expanding menu of molecular assays, including NGS gene and MRD panels, FLT3 and NPM1 mutation13485 design controls assays, and B- and T-cell clonality and MRD assessment. Last year LabPMM has expanded its testing capabilities to includeComprehensive NGS gene panels that identify actionableInternationally standardized CDx and biomarker testingMRD flow cytometry. Our comprehensive test menu will now eliminate the need for partners to split primary specimens,biomarkers with ISO 15189 labs serving the US, Europe, a locallydramatically decreasing turnaround times and allowing for coherent comparison of flow-based andNGS-based MRD test accredited lab in Asia, including clinical trial managementresults.Custom biomarker assay developmentin China State of the ArtComprehensive LymphoTrack clonality/MRD assays and CAP and CLIA-certified NGS MyGene panels identifyWe thrive in international cooperation and in continuous investment in the advancement of precision medicine. We workclinically actionable biomarkers with a full range of collaborators: key opinion leaders, leading healthcare institutions, and top-tier pharmaceuticalQuality/Regulatory/Commercialization companies. We work on the premise that all those reliant on data and results from clinical testing (healthcare providers,Global Regulatory ExpertiseComplementary MRD assays for all biomarkerspotentialpharmaceutical companies and most importantly, patients) will benefit from better standardization and more consistent for surrogate endpoints per agency inputs performance of molecular diagnostic tests. Experienced staff & proven Quality Management System Testing services have supported hundreds of enrollmentFull adherence to FDA 21 CFR part 820 and ISO13485 sites worldwide Quality standards Internationally-harmonized diagnostics through our global network ofRegistered Medical Device Establishment with the US FDA,laboratories. We follow full QSR design control for assay and softwareKFDA, Saudi Arabia, and the PMDA development. Products are manufactured under cGMP and ISO 13485. Multiple CDx approvals supporting various drugs: by the FDA (US), PMDA/MHLW (Japan), and TGA (Australia).CDx ManufacturingPartnership CE-marks in the EU FDA/CDRH-registered and ISO 13485-certified cGMP We support partnerships worldwide to develop, validate, and50 CE-marked IVDsavailable in the EU and select ROW manufacturing facility based in San Diego commercialize molecular assays and reagents. Our global distributionmarkets; network operates in more than 700 laboratories in 160 countries. Comprehensive Dx and CDx Manufacturing 60 tests registered with the ARTG in Australia- PMA CDx for US, Japan, EU, Australia, and ROW markets - 50 CE-IVDs (NGS assays + bioinformatics software)Marketing Authorization Holder (MAH) and NationalExpertisereimbursement for CDx in Japan. CDx submitted for IUO & RUO assays, ASRs & GPRsreimbursement in the US With 25 years of experience we are the foremost experts in providingDNA / RNA controls, MRD controls & proficiency panelsmolecular products and services for leukemia and lymphoma testing.Supporting ongoing clinical drug trials in the US, EU,We offer dedicated support in design and development, manufacturing,Japan, China and ROW.software and bioinformatics, technical support, quality assurance, and global regulatory affairs. 6 LabPMM Services Catalog 2020|7'