From Sample to Success: How Quality Biospecimens Fuel Effective Biomarker Strategies
Biomarker research is a rapidly evolving field that provides valuable insights into the diagnosis, treatment, and prevention of a wide range of diseases and conditions. According to data from Grand View Research, the global biomarkers market size was valued at USD 66.97 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 13.3 % from 2021 to 2028.
Biomarkers are measurable indicators of physiological or pathological processes in the body, and can include molecules such as proteins, nucleic acids, and metabolites, as well as cellular or structural changes. They help identify individuals who are at increased risk of developing certain conditions, such as cancer or cardiovascular disease, allowing for earlier intervention and improved outcomes.
Biomarkers are particularly significant in the development of personalized medicine which enables clinicians to tailor treatment according to an individual's unique genetic makeup. Personalized medicine has experienced a great uptake in cancer research and cancer biomarkers are the most extensively researched area in biomarker research. By 2019, the most studied cancer biomarkers included: KRAS, TP53, EGFR, BRAF, and PIK3CA. COVID-19 biomarkers: including C-reactive protein (CRP), interleukin-6 (IL-6), and D-dimer played a key role in the diagnosis and treatment of COVID-19.
Despite its enormous potential, biomarker research faces a number of challenges, a significant one being how to procure racially-diverse and high quality biospecimens. As such, the development of effective biomarker strategies requires close collaboration between the research team and biospecimen procurement companies, as well as ongoing investment in technology, infrastructure, and training.
What Makes a Good Quality Biospecimen?
To ensure that the research is accurate and reliable, high-quality biospecimens are essential. Quality biospecimens are those that are collected, processed, and stored with a consistent and standardized protocol that ensures their integrity and stability. These four factors contribute to the quality of biospecimen:
Collection: The collection process should be standardized to minimize any variables that may affect the sample. This includes using the appropriate collection equipment, such as sterile needles and tubes, and following standardized collection procedures across different sites.
Processing: After collection, the biospecimen must be processed correctly to maintain its integrity. This includes separating the different components of the biospecimen and ensuring that they are stored in the appropriate conditions.
Storage: The storage conditions for biospecimens must be consistent, and the sample must be protected from contamination, light, and extreme temperatures.
Documentation: Complete documentation of the biospecimen's history, otherwise called provenance, is critical to ensuring its quality. This includes information such as the time and date of collection, the method used for collection, processing, and storage, as well as any deviations from the standard protocol.
Quality biospecimens are critical to a good biomarker strategy because they provide accurate and reliable data that can be used to identify and measure biological markers. Here is more about what makes a good biomarker strategy.
What Makes a Good Biomarker Strategy?
A good biomarker strategy should be tailored to meet the specific goals of the study or clinical trial. It should be designed to identify, quantify, and interpret biomarkers that are relevant to the disease being studied. A good strategy should provide reliable, accurate, and reproducible results.
It should select appropriate biomarkers
One important aspect of a good biomarker strategy is the selection of the appropriate biomarkers. Biomarkers can be measured in different sample types, including blood, urine, and tissue samples. The selection of the sample type and the biomarker must be based on the research question and the characteristics of the biomarker. It is also important to consider the sensitivity, specificity, and accuracy of the selected biomarkers, as these factors can impact the reliability of the results.
It should prioritize sample management
Another important aspect of a good biomarker strategy is the sample collection and storage methods. The samples must be collected using standardized procedures to ensure consistency and minimize variability. The storage conditions must also be optimized to maintain the stability of the biomarkers over time. Factors such as temperature, humidity, and the use of preservatives can all impact the quality of the samples.
It should utilize data analysis methods that are accurate and intuitive
In addition to the selection of biomarkers and the sample collection and storage methods, a good biomarker strategy must also include appropriate data analysis methods. The analysis must be able to accurately measure the biomarker levels and provide meaningful insights into the relationship between the biomarkers and the disease or condition being studied. The data analysis methods must also be validated and reproducible to ensure the accuracy and reliability of the results.
The strategy should be based on scientifically sound principles
Overall, a good biomarker strategy should be based on sound scientific principles and designed to meet the specific needs of the study or clinical trial. It should incorporate standardized procedures for biomarker selection, sample collection and storage, and data analysis to ensure the reliability and reproducibility of the results.
Importance of Quality Biospecimen for biomarker strategy
To effectively develop and execute a biomarker strategy, high-quality biospecimens are crucial. Here are four reasons why high-quality biospecimens are important for a good biomarker strategy:
Accurate analysis
High-quality biospecimens guarantee accurate analysis of biomarkers. When biospecimens are collected using improper techniques, the results of biomarker analyses may be inaccurate or biased, which can lead to incorrect diagnosis, prognosis, or treatment decisions. High-quality biospecimens are collected and stored using standardized protocols, which minimize variability and ensure consistent results.
Reproducibility
Reproducibility is a key requirement for scientific research. This is particularly important when biomarkers are being validated across multiple sites or when clinical trials are being conducted across different laboratories. When biospecimens are not collected and stored properly, the variability in the quality of the samples can affect the reproducibility of the results.
Cost-effectiveNESS
The use of high-quality biospecimens can save time and money in the long run. When biospecimens are collected and stored properly, they are more likely to yield reliable results. This reduces the need for repeat experiments, which can be costly and time-consuming. Additionally, high-quality biospecimens can be used for multiple analyses, which can further reduce costs.
Better patient outcomes
Ultimately, the goal of biomarker strategies is to improve patient outcomes. High-quality biospecimens are essential to ensure that biomarker analyses are accurate and reproducible, which can lead to better diagnoses, prognoses, and treatment decisions. This can ultimately improve patient outcomes and quality of life.
High-quality biospecimens are essential for a good biomarker strategy. Accurate analysis, reproducibility, cost-effectiveness, and better patient outcomes are some of the key benefits of using high-quality biospecimens. Researchers and clinicians should prioritize the collection and storage of high-quality biospecimens to ensure the success of their biomarker strategies.
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References
Grand View Research. (2021). Biomarkers Market Size, Share & Trends Analysis Report By Product (Consumables, Services), By Type (Safety, Efficacy, Validation), By Application (Diagnostics, Drug Development), By Disease Indication, And Segment Forecasts, 2021 - 2028. Retrieved from https://www.grandviewresearch.com/industry-analysis/biomarkers-industry
National Cancer Institute. (n.d.). Tumor Markers. Retrieved May 6, 2023, from https://www.cancer.gov/about-cancer/diagnosis-staging/diagnosis/tumor-markers-list
Niven, D. J., McCormick, T. J., Straus, S. E., Hemmelgarn, B. R., Jeffs, L., Barnes, T. R. M., & Stelfox, H. T. (2018). Reproducibility of clinical research in critical care: a scoping review. BMC medicine, 16(1), 26. https://doi.org/10.1186/s12916-018-1018-6
