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Board-Certified Pathology Review

Ensuring FFPE Biosamples are Accurately Characterized

Formalin-fixed paraffin-embedded (FFPE) samples are a valuable resource for biomedical research. These samples, typically archived in biobanks, provide long-term storage and preservation of tissue specimens. Board-certified pathologists are essential in reviewing these samples to ensure accurate diagnoses and reliable research data. This article outlines a comprehensive methodology to review FFPE biosamples by board-certified pathologists.

"A well-structured methodology for reviewing FFPE biobank samples by board-certified pathologists is essential for ensuring the validity, accuracy, and reliability of the data generated from these precious resources." 

Sample retrieval and cataloguing

The first step in the review process is to retrieve the FFPE samples from the biobank storage. Maintaining a well-organized cataloguing system that includes information about the sample source, patient demographics, and relevant clinical data is essential. This information will assist pathologists in understanding the context and relevance of the samples under review.

Sample preparation

Preparing the FFPE samples for review involves several steps:


A microtome is used to cut thin tissue sections, typically 4-5 micrometres thick, which are then mounted onto glass slides.

Dewaxing and rehydration

The tissue sections must be dewaxed and rehydrated through a series of steps using xylene and graded alcohols.


Hematoxylin and eosin (H&E) staining is the most common method for routine histopathological evaluation. Depending on the case, special stains or immunohistochemical (IHC) markers may be required.

Pathological review

The pathologist will review the stained slides under a light microscope to assess the tissue architecture and cellular morphology. They will evaluate the samples using their expertise in histopathology, considering factors such as:

a. Tumor type and grade

b. Inflammation or other pathological changes

c. Necrosis or fibrosis

d. Cellular atypia or pleomorphism

e. Presence of mitotic figures

Digital slide scanning and storage

Digital slide scanning technology allows the creation of high-resolution digital images of stained slides, which can be viewed, analyzed, and shared electronically. These digital images are essential for telepathology, research collaboration, and quality assurance purposes. Storing the digital images in a secure, organized manner ensures easy access for future reference and analysis.

Data reporting and integration

The pathologist's observations and diagnoses should be documented in a standardized format, such as the College of American Pathologists (CAP) cancer protocols. This report should be integrated with the sample's clinical data and stored in a secure database, allowing researchers to efficiently access and analyze the combined data.

Quality assurance and peer review

Quality assurance measures should be implemented to maintain the accuracy and consistency of the pathologists' evaluations. Periodic peer review and interobserver variability assessments can help identify discrepancies and areas for improvement.


As biobanks continue to play a critical role in medical research, it is imperative to have a robust review process in place for the proper characterization and evaluation of FFPE samples. Implementing the methodology outlined in this blog post guarantees that the samples are thoroughly and accurately characterized and instils confidence in researchers who utilize these samples for various scientific investigations. A rigorous review process helps minimize discrepancies and errors, producing more accurate and reproducible findings. As a result, researchers can trust the quality of the samples and the data derived from them, ultimately advancing our understanding of diseases and contributing to developing novel diagnostic and therapeutic approaches.

Additionally, an effective review methodology promotes collaboration between biobanks and the scientific community by maintaining a high-quality standard and fostering a culture of continuous improvement. Regular training, workshops, and conferences for pathologists help ensure that they stay up-to-date with the latest advancements in their field, ultimately benefiting the entire research ecosystem.

The importance of a comprehensive methodology for reviewing FFPE biobank samples by board-certified pathologists cannot be overstated. By adhering to the steps outlined in this article, biobanks can ensure that their FFPE samples are consistently and accurately characterized, facilitating the success of current and future research endeavours. Ultimately, a robust and rigorous review process contributes significantly to the progress of medical research and the improvement of patient care. 

Please click on the links below to inquire about the Compare Biomarket® range of clinical biospecimens and services suitable for your unique human health research needs.

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