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. Jump to: In Vitro Diagnostic (IVD) Development Clinical Sample Sourcing Clinical Sample Management, Storage, and Processing IVD Assay Development and Comparator Testing In Vitro Diagnostics Kit Manufacturing Informatics Solutions for Diagnostic Laboratories In Vitro Diagnostic (IVD) Development Azenta Life Sciences is your partner forin vitrodiagnostic (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 forin vitrodiagnostic 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 managementto ensure sample collection compliance 专家科学家to ensure the correct pre-analytical and collection criteria Sample traceabilityto ensure ethical standards of consent and collection World-wide coveragewith 147 partners in 26 countries Multilingual teamto 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 裁员的风险缓解策略 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 无细胞/循环DNA提取 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 laboratorieswith independent quality assurance oversight 完整的解决方案管道, from nucleic acid extraction and sequencing to data analysis and sample storage (if needed) Dedicated Study Manager/Director在整个项目中进行积极主动的透明沟通 Assay development expertise在测定优化和处理困难模板方面表现出色 Customized study reports and documentationspecifically tailored to client specifications Stringent quality control根据您的项目需求,具有多个评论和已建立的标准操作程序(SOP),以产生一致的结果 In Vitro Diagnostics Kit Manufacturing 在Azenta,我们设计和生产创新的产品,以满足套件制造商和最终用户的需求,同时每次确保可重现的结果。我们的各种产品范围可以在制造商的网站上机器人处理,后来分为较小的部分,以适合最终用户的特定要求。使用高质量的产品为您的诊断套件制造增添信心: ISO 9001 and ISO 13485 certified Custom-made or off-the-shelf Automation-friendly Consistently available Learn more about ourcapabilities和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. 诊断基本模块功能和好处 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 通过直观的用户界面(UI)操作,导致高度采用 EXPLORE INFORMATICS SOLUTIONS FOR DIAGNOSTICS