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When developing critical assays, such as liquid biopsy-based cancer tests and pre-natal genetic screening kits, the composition of blood collection tu…
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Developing a liquid biopsy assay can feel like a journey into uncharted territory, but with the right guidance, it’s a mission you can accomplish with ease. In this blog, we’re here to simplify the process and provide clear, actionable steps to ensure your success. From selecting the right body fluid and biomarker to choosing effective collection methods, every decision plays a crucial role in achieving reliable results. Let the countdown begin!
The first critical step in your liquid biopsy assay development journey is selecting the appropriate body fluid. This decision sets the stage for the rest of your assay development and directly impacts the success of your project. You have two primary options: blood or urine. Each offers unique advantages and considerations.
Blood
- Most commonly used body fluid for liquid biopsies due to its rich reservoir of biomarkers, including cell-free DNA (cfDNA), cell-free RNA (cfRNA) and various proteins
- Particularly advantageous for detecting a wide range of conditions and is widely accepted in clinical settings
Urine
- Provides a non-invasive alternative
- Can be easier to collect.
- Is increasingly recognized for its potential in detecting certain types of cancer and other diseases
- May not be as rich in some biomarkers as blood, which could limit its utility depending on your specific needs
With the body fluid selected, the next step is choosing the right biomarker. This biomarker will be the focal point of your assay, so choose wisely!
Cell-free DNA (cfDNA)
- Is a popular choice due to its stability and abundance in the bloodstream
- Has the ability to offer insights into genetic mutations that can be pivotal in cancer detection and monitoring
Cell-free RNA (cfRNA)
- Is less stable than cfDNA
- Provides crucial information about gene expression and can reveal active biological processes within cells
Proteins
- Offer a direct look at the functional state of cells
- Can be used to detect a variety of diseases
When choosing your biomarker, it’s essential to consider your assay’s objectives. If you’re targeting genetic mutations or epigenetic changes, cfDNA might be your best bet. For understanding gene activity and regulation, cfRNA is more suitable, while proteins are invaluable for gaining insights into the biological pathways and functions in play.
With your body fluid and biomarker locked in, it’s time to figure out how samples will be collected. The collection method you choose is paramount to the integrity and reliability of your liquid biopsy assay, as both body fluids and biomarkers are subject to degradation over time. To address this issue, consider preserving the sample integrity by collecting into a stabilizing blood collection tube or by adding a stabilization reagent (hey, that’s what we’re known for!). Streck’s patented stabilization solutions maintain draw-time concentrations for cfDNA, cfRNA, EVs and plasma proteins of interest and set you on the path toward reproducible results.
For more information on Streck’s collection solutions and how they can maximize your laboratory efficiency, download our comprehensive stabilization guide.
Now, it’s time to make sure that the biomarkers you’ve so carefully selected are efficiently and accurately isolated from your chosen body fluid.
When working with blood samples, it’s crucial to employ an extraction method that can handle the complexities of the sample matrix. Kit-based extraction methods are often favored for their reliability and efficiency. Many commercially available kits are designed to isolate cfDNA, cfRNA and proteins with high purity and yield. Selecting the right kit depends on the biomarker type and the downstream analysis requirements.
For cfDNA, consider kits that offer high recovery rates and are compatible with the volume of your samples. These kits should also minimize the degradation of the DNA during the extraction process. For cfRNA, stability is key, so look for kits that include stabilizing agents to protect the RNA throughout the procedure. Protein extraction kits should provide a means to capture the specific proteins of interest without significant loss or contamination.
Let’s turn our attention to analysis. This phase is where the true power of your chosen biomarkers and meticulous preparation comes to light. Choosing the right analytical method is crucial to translating the biological signals into meaningful insights.
Next-Generation Sequencing (NGS)
NGS is a powerful tool for examining cfDNA and cfRNA, providing comprehensive genetic and transcriptomic profiles. This method allows for the detection of mutations, copy number variations and other genetic alterations with high sensitivity and specificity.
Mass Spectrometry
For protein biomarkers, mass spectrometry offers precision in identifying and quantifying proteins within complex biological samples. This technique is ideal for uncovering protein expression patterns and post-translational modifications, offering a window into cellular functions and disease states.
By carefully selecting and optimizing your analytical method, you ensure that the data generated is both accurate and actionable.
As we near liftoff, securing regulatory approval is a mission-critical step in launching your liquid biopsy assay. This stage involves ensuring your assay meets the stringent guidelines and standards set by regulatory bodies to ensure it is safe, effective and reliable for clinical use.
Collaboration with experienced partners can streamline this process. Our expertise in sample stabilization and compliance with regulatory standards can provide invaluable support.
Liftoff!
With all preparations complete, it’s time for liftoff. This is where your diligent work transforms into actionable insights that can make a difference in clinical diagnostics and patient care. As they say in Houston, good luck and Godspeed!
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