Blog Biospecimens as the Foundation of Personalized Medicine

Biospecimens as the Foundation of Personalized Medicine

The shift from standardized, population-level treatment toward therapies tailored to the individual patient is one of the most significant transitions in the history of modern medicine. Personalized medicine and precision medicine are often used interchangeably, though personalized medicine tends to emphasize the patient-level application of the insights generated by precision medicine.

Driving this shift at every level, from the earliest stages of drug discovery to the clinic, are biospecimens: the biological samples that make it possible to understand not just disease in the abstract, but in each specific patient. This blog will explore how high-quality biospecimens underpin every stage of personalized medicine, from discovery science and biomarker development to ethical governance, diversity, and next-generation technologies.

What Are Biospecimens?

Biospecimens are biological materials collected from human donors [1]. They are the essential starting point for genomics, proteomics, metabolomics, and translational research, all of which power modern diagnostics and drug development.

Demand for these services is growing rapidly. Accelerating cancer incidence, expanding genomics research programs, and the growing complexity of clinical trials are all driving this surge. The increase in genomic, post-genomic, and precision medicine research is increasing the demand for high-quality, well-annotated specimens, making them more difficult to source.

Biospecimens span a wide biological range and can include:

  • Tissue – Obtained by biopsy or surgical resection, tissue provides direct access to cellular architecture and the tumor microenvironment. FFPE blocks are standard for histopathology and immunohistochemistry, whereas fresh-frozen tissue is preferred for RNA integrity [2,3].
  • Saliva – Saliva or buccal swabs offer a genuinely non-invasive source of human DNA, practical for large-scale studies and suitable for populations where more invasive collection is a barrier to participation [4,5].
  • Blood – Whole blood, plasma, serum, peripheral blood mononuclear cells, and buffy coat are among the most requested specimen types in translational research. As a minimally invasive matrix that can be collected at multiple time points, blood is well-suited to longitudinal biomarker monitoring and liquid biopsy applications [6,7].
  • Other bodily fluids – Urine, cerebrospinal fluid, or lung fluid carry metabolic and proteomic signals relevant to renal disease, neurological conditions, or respiratory pathology [8–10]. As the field of proteomics matures, the utility of these matrices continues to grow.
  • Patient-derived organoids – Grown in three dimensions from donor tissue, organoids maintain much of the genetic character and structural organization of the source material and can undergo multiple rounds of culture and expansion [11]. Responses observed in organoids have been shown to correlate with those seen in the patient, making them a bridge between the biopsy and the clinic and a route for therapeutic testing that does not require repeated invasive sampling [12].

From Biosample to Breakthrough

The most consequential advances in cancer research have depended on access to well-collected, well-characterized biospecimens. The Cancer Genome Atlas (TCGA), a joint effort between the National Cancer Institute (NCI) and the National Human Genome Research Institute, molecularly characterized over 20,000 primary cancer and matched normal samples across 33 cancer types, generating more than 2.5 petabytes of genomic, epigenomic, transcriptomic, and proteomic data [13]. The publicly available datasets from TCGA have been foundational to precision oncology, enabling the identification of actionable driver mutations across tumor types and underpinning the development of targeted therapies that would not have been possible without access to high-quality specimens.

Longitudinally collected blood biospecimens have enabled circulating tumor (ctDNA) liquid biopsy to move from research tool to clinical practice. Real-world data now show that ctDNA profiling can detect disease recurrence months before it appears on imaging, and guide treatment decisions in real time across diverse solid tumor types [14,15]. These advances share a common prerequisite: access to the right specimens, collected correctly from the right patients, at the right time.

A growing focus in precision medicine research is on matched biospecimen sets. These may be different specimen types collected from the same donor at the same time, or the same tissue procured and stored in different ways. Matched sets are important for liquid biopsy validation, enabling researchers to confirm whether biomarkers detectable in blood correspond to tumor-specific alterations confirmed in tissue. Our own data reflect this shift with matched donor cases rising from 25% of all collections in 2020 to 54% in 2022, a clear signal of where the field is heading.

How Biospecimens Translate into Targeted Therapies

The use of biospecimen-derived molecular data to guide drug development has progressed well beyond proof of concept. It now defines how most oncology therapies are designed and approved.

Case One – TAGRISSO® (osimertinib)

Tumor tissue collected from non-small cell lung cancer (NSCLC) patients has enabled systemic sequencing that identified activating mutations in the EGFR gene as drivers of a specific disease subset [16]. This molecular characterization created the basis for inhibitors of the mutated receptor, ultimately leading to TAGRISSO® (osimertinib), which demonstrated a median progression-free survival of 39.1 months versus 5.6 months for placebo in EGFR-mutated NSCLC [17]. The ability to select patients by tumor genotype, which is made possible only through access to high-quality tissue specimens, was what allowed these trials to succeed where earlier trials had not.

Case Two – Pembrolizumab

The same is true in immunotherapy. Checkpoint inhibitors targeting the PD-1/PD-L1 axis could only be developed through systematic characterization of tumor specimens, first for PD-L1 expression, and subsequently for broader genomic features like tumor mutational burden [18,19]. The impact of patient selection was substantial: pembrolizumab achieved an objective response rate of approximately 44.8% in patients with PD-L1 TPS ≥50%, compared with 14-23% in unselected populations [20,21]. Tissue remains essential both for initial biomarker assessment and for understanding the resistance mechanisms when response is lost.

Case Three – Tyrosine Kinase Inhibitors

FFPE tumor tissue collected from patients with diverse solid cancers has enabled comprehensive molecular profiling to identify rare but actionable gene fusions involving NTRK, ALK, and ROS1 as key oncogenic drivers in defined subsets of disease [22]. This characterization provided the basis for the development of highly selective tyrosine kinase inhibitors (TKIs), including tumor-agonistic NTRK inhibitors that deliver substantial and durable responses in patients whose tumors harbor these rearrangements, irrespective of the tissue of origin. The ability to detect and verify these fusions in high-quality FFPE biospecimens is what has allowed patient selection by tumor genotype and ultimately enabled regulatory approvals and line-of-therapy decisions to be anchored in molecular profiling rather than histology alone.

Biospecimen Diversity in Research

Diversity in biospecimen collection is not just an ethical obligation, but a scientific requirement. Individuals from the same ancestral population share genetic features that influence drug response, efficacy, and disease susceptibility. A 2016 analysis of TCGA data showed that every racial minority group was underrepresented, limiting the reliability of mutation-prevalence findings across diverse populations [23]. Research by the NHS Race and Health Observatory similarly found that ethnic minority groups are largely absent from participating in genetic studies, with measurable consequences for health outcomes [24]. Sourcing specimens from limited geographic areas means that biomarker expression findings may not translate to a broader, more diverse patient population.

Significant efforts are underway to close this gap. The NIH’s All of Us Research Program has released genomic data from over 245,000 participants, with approximately 46% identifying as individuals from racial or ethnic minorities historically underrepresented in biomedical research [25]. Programs combining global site networks, spanning partners across North America, South America, Europe, Africa, and Asia, demonstrate that diverse, globally representative biospecimen collection is operationally achievable with the right infrastructure in place.

Ethical and Regulatory Foundations

The scientific value of biospecimens cannot be separated from the ethical framework within which they are collected. Informed consent is a foundational requirement. Donors should receive a clear explanation of how their samples will be used, by whom, and for what purpose.

The core consent models are [26]:

  • Broad (or umbrella) consent: Permits future unspecified use.
  • Specific consent: Limits participation to defined studies.
  • Tiered consent: Donors may choose from a “menu” of options, which means they can decide the types of research their biospecimen can be used for [27].
  • Dynamic consent: Donors have access to a platform that allows them to withdraw consent for new studies if they wish to in real-time [28].

Data privacy adds further complexity. Even de-identified samples carry sensitive genetic information, and the growing sophistication of re-identification methods means genomic data cannot be treated as fully anonymous [29]. The General Data Protection Regulation (GDPR) in Europe and the Health Insurance Portability and Accountability Act (HIPAA) in the United States impose obligations around data handling, but their reconciliation in internationally collaborative research remains imperfect [30,31].

The case of Henrietta Lacks remains the central reference point for biospecimen ethics. Her cervical cancer cells were collected without consent in 1951, becoming the globally used HeLa cell line that contributed to the development of the polio vaccine and to decades of cancer biology, virology, and genetics research [32]. In 2021, her family filed a federal lawsuit against Thermo Fisher Scientific for profiting from her cells without consent or compensation. A confidential settlement was reached in August 2023 (what would have been Lacks’ 103rd birthday), marking a significant, though partial step toward recognizing donors’ stake in the value generated from their specimens [33].

Modern governance frameworks address these concerns through institutional review board oversight, ethical review of data access requests, and benefit-sharing arrangements [34–36]. Transparency about commercial involvement in specimen collection is increasingly regarded as a minimum standard [37].

Biospecimen Quality

Securing the right type of specimen is only half the challenge. Quality is equally important to whether a study generates reliable, reproducible data. Differences in collection, processing, storage, and transport can alter DNA integrity, RNA stability, protein abundance, and metabolite profiles [38–40]. When these variables are not controlled or reported, they introduce bias, reduce assay sensitivity, and make it difficult or impossible to validate biomarkers.

Seemingly small variations, including time to fixation, ischemia time before freezing, storage temperature, and freeze-thaw cycles, can markedly affect downstream molecular readouts. Delayed processing has been linked to RNA degradation, altered phosphoprotein profiles, and changes in serum cytokine signatures, all of which can confound gene expression studies [39,40]. The NCI and the International Society for Biological and Environmental Repositories have published best-practice frameworks defining minimum standards for collection, processing, storage, and stewardship of associated data [39,41,42]. The guidelines emphasize standard operating procedures, staff training, equipment qualification, and quality control assays as the backbone of biospecimen quality assurance and control.

Bottlenecks in the Innovation Cycle

Despite their importance to personalized medicine, accessing high-quality biospecimens remains one of the most persistent challenges in translational research. Most high-quality specimens originate in public-sector settings, including hospitals, reference laboratories, and academic medical centers. However, private-sector research has limited structured access to these resources. This disconnect slows the development of new therapies, delays validation studies, and creates friction at the point where research momentum is most critical.

Traditional biobanks, designed primarily for general-purpose archiving rather than research-driven collection, often cannot account for the breadth of specimen types and time-point combinations that modern studies demand. When collections are not designed around specific research protocols from the outset, valuable material is wasted, and timelines are unnecessarily extended. The field is increasingly recognizing that custom, built-for-purpose, often longitudinal, biospecimen and associated data collections sourced through a combination of active biobanking, clinical remnant acquisition, and prospective procurement are the model that will drive the next generation of personalized medicine forward [43].

Emerging Technologies

Advances in analytical technology are changing what can be extracted from a biospecimen, often in ways that were not anticipated at the time of collection.

Artificial intelligence is enabling pattern recognition across biospecimen-derived datasets at a scale that manual analysis cannot match. Machine learning models trained on genomic, transcriptomic, and proteomic data from large specimen cohorts are now used to predict treatment responses, stratify patients, and identify novel biomarker candidates [44]. The quality of those outputs, however, is only as good as the quality of the specimens used to train them.

Single-cell sequencing has moved analysis from bulk tissue assessments to the resolution of individual cells. This reveals intratumoral heterogeneity, resistance-conferring subpopulations, and immune infiltrate composition that bulk sequencing cannot resolve [45]. These workflows require viable, dissociated cells, placing new demands on rapid, standardized tissue handling [46].

Multi-omics integration is the simultaneous analysis of genomic, transcriptomic, proteomic, and metabolic data from the same specimen or matched specimen set. It is generating the most comprehensive biological profiles yet achieved from human tissue and beginning to produce clinically actionable insights in complex diseases [47].

Advanced cryopreservation and robotic biobanking systems support all of these advances by ensuring that specimens collected today remain scientifically useful for the studies of tomorrow [48,49].

High-resolution mass spectrometry is expanding the detectable molecular space within biobanked specimens, revealing low-abundance metabolites, lipids, and post-translationally modified peptides that were previously unseen with older platforms [50]. These advances allow researchers to retrospectively mine archived samples for new biomarker candidates and mechanistic insights without recollecting material.

Spatial transcriptomics extends RNA sequencing into physical space, mapping gene expression across intact tissue sections while preserving histologic architecture [51,52]. By combining transcriptome-wide profiling with spatial coordinates, these methods reveal how malignant, stromal, and immune cells are organized within the tumor microenvironment and how local niches shape gene expression programs.

As personalized medicine continues to move from vision to everyday clinical reality, the success of new diagnostics and therapies will depend as much on the quality, diversity, and governance of the underlying biospecimens as on the sophistication of downstream analytics. Investing in ethically sourced, rigorously handled, and truly representative samples is therefore not just an operational detail, but the foundation on which more precise, equitable care will be built.

For information on how quality biospecimen procurement supports precision medicine and cancer research, visit audubonbio.com or get in touch with our team.

Frequently Asked Questions

What is the difference between a biospecimen and a biobank?

A biospecimen is the biological sample itself, including blood, tissue, plasma, and so on. A biobank is the facility or system that collects, processes, stores, and manages these samples for research use.

Why does the quality of a biospecimen matter so much?

Pre-analytical variables such as time to process, storage temperature, and freeze-thaw cycles can alter molecular profiles significantly, sometimes more than the biological signal being studied. Poor-quality specimens produce unreliable data regardless of how sophisticated the downstream assay is.

What are matched biospecimen sets?

Matched sets are specimens collected from the same donor, either different types at the same time or the same type at multiple time points. They are essential for validating liquid biopsy findings against confirmed tissue-based alterations.

Why is diversity in biospecimen collections a scientific and ethical issue?

Genetic variants that influence disease risk, biomarker expression, and drug response differ across populations. A biomarker discovered in a predominantly white cohort may not perform equally in patients of other ancestries, limiting the generalizability and equity of precision medicine findings.

How is informed consent evolving in biospecimen collection?

Beyond the traditional broad or specific consent models, tiered and dynamic consent approaches are gaining adoption. Dynamic consent platforms allow donors to update their preferences in real time as new studies are proposed, giving them ongoing agency over how their samples are used.

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