b'Partner with Us An Ideal CDx Partner PartnerCONTACT US FOR MORE INFORMATION: businessdevelopment@invivoscribe.com for Drug Approvals with UsYour Ideal Partner for Laboratory Services, Clinical Trial Testing, and CompanionIVD Product DevelopmentDiagnostic Development Over 25 years of assay development experience LabPMM (an Invivoscribe company) is your partner of choice for diagnostic, research, and clinical trial services. Biomarker assays & software development under full ISO 13485 design controls Our network of laboratories located in the USA, Europe and Asia specialize in internationally harmonized molecular testing,Comprehensive NGS gene panels that identify actionable biomarkers and flow cytometry, and collectively have CLIA and ISO 15189 certifications via CAP and DAkkS. We also offer contract researchCustom biomarker assay and CDx developmentorganization (CRO) services, and are a comprehensive companion diagnostics (CDx) and custom assay development partner, providing ISO 13485-compliant biomarker development, cGMP manufacturing, regulatory capability, global laboratory services and commercialization.Global Regulatory, Quality and Commercial ExpertiseWe offer an ever expanding menu of molecular assays, including NGS gene and MRD panels, FLT3 and NPM1 mutation assays,Experienced staff & proven Quality Management System and B- and T-cell clonality and MRD assessment. Last year LabPMM has expanded its testing capabilities to include MRD flowFull adherence to FDA 21 CFR part 820 and ISO13485 standards cytometry. Our comprehensive test menu will now eliminate the need for partners to split primary specimens, dramatically decreasing turnaround times and allowing for coherent comparison of flow-based andNGS-based MRD test results.Registered Medical Device Establishment with the US FDA, KFDA, Saudi Arabia, and the PMDA State of the ArtMultiple CDx approvals supporting various drugs: by the FDA (US), PMDA/MHLW (Japan), and TGA (Australia).CDx CE-marks in the EU We thrive in international cooperation and in continuous investment in the advancement of precision medicine. We workwith a full range of collaborators: key opinion leaders, leading healthcare institutions, and top-tier pharmaceutical companies.50+ CE-marked IVDsavailable in the EU and select ROW markets; We work on the premise that all those reliant on data and results from clinical testing (healthcare providers, pharmaceutical companies and most importantly, patients) will benefit from better standardization and more consistent performance of60 tests registered with the ARTG in Australia molecular diagnostic tests. 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.Quality Clinical TestingGlobal Clinical Reference Laboratory NetworkInternationally-harmonized diagnostics through our global network of laboratories. We follow full QSR design control for assay and softwareA dozen years of clinical reference lab experience development. Products are manufactured under cGMP and ISO 13485.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 clinicallyPartnership actionable biomarkers Complementary MRD assays for all biomarkerspotential for surrogate endpoints per agency inputs We support partnerships worldwide to develop, validate, and commercialize custom biomarker assays and reagents. Our global distribution networkTesting services have supported hundreds of enrollment sites worldwideoperates in more than 700 laboratories in 160 countries.ManufacturingExpertiseFDA/CDRH-registered and ISO 13485-certified cGMP manufacturing facility based in San Diego With over 25 years of experience we are the foremost experts in providingComprehensive Dx and CDx Manufacturing CDx for USA (PMA), Japan, EU, Australia, and ROW markets molecular products and services for oncologic testing. We offer dedicated support in design and development, manufacturing, software and50+ CE-IVDs (NGS assays + bioinformatics software) IUO & RUO assays, ASRs & GPRsbioinformatics, technical support, quality assurance, and global regulatoryDNA / RNA controls, MRD controls & proficiency panelsaffairs.6 LabPMM Services Catalog 2021|7'