Introduction
The provided source material details a specialised laboratory service offered by Azenta, a company that provides sample storage and preparation services. This service focuses on the extraction of cell-free DNA (cfDNA) from liquid biopsies, primarily for use in diagnostic discovery and development. The information is targeted at researchers, diagnostic developers, and institutions, not at general consumers seeking free product samples or promotional offers. The service involves a fully automated workflow for processing blood or plasma samples to isolate cfDNA, which has applications in disease research, companion diagnostics, and early disease detection. The documentation outlines the workflow steps, accepted starting materials, recommended collection tubes, and available customisation options. It is important to note that this is a commercial laboratory service, not a free sample programme for consumer goods.
Overview of Cell-Free DNA and Its Applications
Cell-free DNA (cfDNA) refers to fragments of DNA that are found in biological fluids, such as blood plasma, outside of cells. According to the provided documentation, cfDNA holds significant potential for improving clinical practice. Its applications include advancing basic disease research by improving the understanding of cfDNA release mechanisms and tissue origins. Furthermore, cfDNA can be used as a companion diagnostic to identify cancer treatment options through the analysis of specific mutations or chromosomal aberrations. Other potential uses include early detection of cancer, identifying the tissue of origin for cancers, monitoring therapy effectiveness, and assessing emerging resistance or minimal residual disease. These applications highlight the importance of reliable and high-quality cfDNA extraction methods for research and diagnostic purposes.
The Cell-Free DNA Extraction Service from Azenta
Azenta offers a fully automated, proprietary liquid biopsy workflow designed to extract cfDNA from plasma. The primary goal of this service is to promote sample quality and consistency. The workflow is flexible and can accommodate either whole blood or isolated plasma as the starting material. Samples can be processed either when newly shipped to Azenta or when already stored at an Azenta site. The service is structured around a defined multi-step process to ensure sample integrity and quality throughout the extraction and assessment phases.
Workflow Steps
The cfDNA extraction workflow is broken down into five distinct steps:
- Receive Sample & Register to LIMS: Upon receipt, the sample is registered or updated in the Limfinity® Sample Management System. This system supports compliance with 21 CFR, part 11 and provides continual tracking of parent/stock samples and child/aliquot relationships. Samples are either shipped to Azenta or retrieved from their existing storage.
- Sample Processing: Processing begins within 24 hours of sample receipt or retrieval. Azenta follows unified Standard Operating Procedures (SOPs) to ensure consistent sample integrity and quality.
- cfDNA Extraction: Cell-free DNA is isolated using quality-controlled processes, which include silica column or magnetic bead-based technologies.
- Quality Assessment: A proficiency-tested methodology is employed for quality checks. This includes assessing DNA recovery rates, concentration, and yield.
- Cryopreservation & Storage or Downstream Analysis: Following extraction, the sample can be stored at Azenta for future use or prepared for downstream analysis. Downstream analysis options mentioned include Clinical Sequencing and CLIA Whole Genome services.
Starting Materials and Recommended Tubes
For clients shipping new samples, Azenta provides specific recommendations to achieve the best results. The accepted starting materials are whole blood or isolated plasma. The recommended collection tubes are Streck® Blood DNA tubes, PAXgene™ Blood DNA tubes, or equivalent tubes that provide similar performance. Using the recommended tubes is advised to ensure optimal cfDNA yield and quality during the extraction process.
Customisation and Storage Options
Azenta offers several customisation options to tailor the service to specific research needs. Clients can request the following when placing a service request:
- Aliquoting: Customisable cfDNA resuspension buffer and aliquoting strategies.
- Pooling: Multiple cfDNA extractions can be pooled to create combined samples.
- Plasma Storage: Aliquots of spun plasma can be stored for future extraction, allowing for flexibility in research planning and sample management.
These options provide researchers with the ability to design a workflow that fits their experimental design and long-term sample storage requirements.
Process for Accessing the Service
The documentation indicates that the service is accessed through direct contact with Azenta. To request the service or a customised workflow option, interested parties should mention their requirements when speaking with a representative or in their message when placing a request. The company also offers the option to request an expert consultation to discuss specific project needs and workflow customisation. This process is a commercial transaction for a laboratory service, distinct from free sample programmes or consumer promotions.
Conclusion
The provided source material describes a specialised cfDNA extraction service offered by Azenta for research and diagnostic development purposes. The service is built on a defined five-step workflow that prioritises sample quality, from receipt and registration through to extraction, quality assessment, and storage or downstream analysis. Key features include the acceptance of whole blood or isolated plasma, the use of recommended collection tubes like Streck® or PAXgene™ tubes, and the availability of customisation options such as aliquoting and pooling. Access to the service requires direct engagement with Azenta representatives. This information is intended for institutional and research use, not for consumers seeking free product samples or trial offers.