Molecular Diagnostic Solutions Accelerate the development of impactful diagnostics. Partner with Azenta Life Sciences to acquire and store the specific clinical samples you need, gain evidence of analytical validity in our CAP/CLIA lab, and access innovative products and consumables for your IVD kits. To support your diagnostics laboratories, Azenta also offers sample tracking software, and consumables and instruments. Place a Request Jump to: In Vitro Diagnostic (IVD) DevelopmentClinical Sample SourcingClinical Sample Management, Storage, and ProcessingIVD Assay Development and Comparator TestingIn Vitro Diagnostics Kit ManufacturingInformatics Solutions for Diagnostic LaboratoriesPlace a Request In Vitro Diagnostic (IVD) Development Azenta Life Sciences is your partner for in vitro diagnostic (IVD) development, from clinical trial sample management and sample sourcing, to assay development and comparator testing, to consumables for IVD validation and commercialization. • Performed by Azenta | • Performed by Client Clinical Sample Sourcing Finding and acquiring the right clinical samples is essential for in vitro diagnostic development and testing. Azenta procures the specific samples required for each project through our extensive network of academic, hospital, and clinical sites-based biospecimen providers across the globe. Retrospective Collections Utilize our network of biobanks for sourcing archived or stored samples Customized Prospective Collections Azenta facilitates prospective or tailored sample collection Regulatory management to ensure sample collection compliance Expert scientists to ensure the correct pre-analytical and collection criteria Sample traceability to ensure ethical standards of consent and collection World-wide coverage with 147 partners in 26 countries Multilingual team to facilitate interactions with global providers EXPLORE SAMPLE SOURCING Clinical Sample Management, Storage, and Processing Sample management, including storage and logistics, is critical in successful IVD development. Azenta’s global biorepository and biobanking solutions enable the storage and management of clinical and sourced samples to support these projects. Sample and Material Storage Comprehensive storage solutions for over 200 sample types Storage temperatures from 27ºC to -196ºC Global state-of-the-art biorepositories Risk mitigation strategies with redundancies Audit tracking with 21 CFR, Part 11 compliant software Rapid retrieval and shipment of samples worldwide in as fast as 24h EXPLORE SAMPLE AND MATERIAL STORAGE Clinical Trial Management Project management Study initiation support Collection kits Patient consent management Sorting and blinding services Discard services with certificate of destruction EXPLORE CLINICAL TRIAL MANAGEMENT Bioprocessing and Sample Preparation Services Blood fractionation PBMC isolation Automated aliquoting Automated nucleic acid extractions Cell-free/circulating DNA extraction EXPLORE BIOPROCESSING AND SAMPLE PREPARATION Cell-Free DNA Isolation Azenta has developed a fully-automated, proprietary liquid biopsy workflow involving cell-free DNA (cfDNA) extraction from plasma designed to promote sample quality. The workflow accommodates either whole blood or isolated plasma as a starting material. Liquid biopsy and cell-free DNA extraction solutions from Azenta help you accelerate diagnostic discovery, development, and delivery. EXPLORE CELL-FREE DNA ISOLATION IVD Assay Development and Comparator Testing Regulatory submissions for in vitro diagnostic (IVD) marketing approval require evidence of analytical validity, which necessitate the procurement of clinical samples for testing and comparison with a 3rd-party assay(s) to determine accuracy. Azenta’s regulatory teams work with clients to develop and validate appropriate comparator assays and customized documentation to support your IVD accuracy assessments. In addition, Azenta can run cleared/approved IVD assays in our CAP/CLIA laboratory. EXPLORE AVAILABLE ASSAYS Comparator Testing Features and Benefits State-of-the-art GLP-compliant and CAP/CLIA accredited laboratories with independent quality assurance oversight Complete solution pipeline, from nucleic acid extraction and sequencing to data analysis and sample storage (if needed) Dedicated Study Manager/Director for proactive, transparent communication throughout the entire project Assay development expertise excelling in assay optimization and handling difficult templates Customized study reports and documentation specifically tailored to client specifications Stringent quality control based on your project needs with multiple reviews and established Standard Operating Procedures (SOPs) to generate consistent results In Vitro Diagnostics Kit Manufacturing At Azenta, we design and produce innovative products which address the needs of both kit manufacturers and end users while ensuring reproducible results every single time. Our diverse range of products can be handled robotically at the manufacturer’s site and later divided into smaller sections to suit the end users’ specific requirements. Add confidence to your diagnostic kit manufacturing with high quality products that are: ISO 9001 and ISO 13485 certified Custom-made or off-the-shelf Automation-friendly Consistently available Learn more about our capabilities and read case studies about how Azenta utilized our automation, barcoding, and other customization capabilities to support collaborations with infectious disease testing kit manufacturers and other valuable customers. EXPLORE KIT MANUFACTURING PRODUCTS Informatics Solutions for Diagnostic Laboratories Azenta Life Sciences offers scalable, powerful, and flexible informatics sample processing solutions that enable lab systems to efficiently deploy across all sites and utilize built-in project and diagnostic operations management functionality. We provide unrivaled sample exploration and management solutions to help you accelerate discovery, development, and delivery. Diagnostic Base Module Features and Benefits Interfaces with external data sources and offers flexible options to integrate with 3rd party systems and instruments Allows users to easily search for data, generate reports, and import or export files Allows ontology and vocabulary management Provides role-based security Regulatory compliance in accordance with FDA 21 CFR Part 11, HIPAA, and GDPR Meets CAP inventory system tracking best practices - system can be configured to capture all necessary information through user-defined fields Includes additional functions like dashboards, email templates, system alerts, automatic inventory monitoring, label printing, and consent management Utilizes cloud-hosting to provide >99.99% uptime and eliminate the need to purchase, maintain, and support server infrastructure Automates lab workflows and optimizes staff workload through standardized processes Allows configurability to meet unique workflow needs with a proven project approach that ensures implementation within the project plan and budgets Provides quality control checks to eliminate data errors and redundancy to increase data integrity Operates through intuitive user interface (UI), resulting in high user adoption EXPLORE INFORMATICS SOLUTIONS FOR DIAGNOSTICS Place a Request Request an Expert Consultation Want to learn more about these solutions? 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