FFPE tumor biospecimens play a fundamental role in advancing modern cancer diagnostics and precision oncology. As digital pathology continues to transform clinical practice, pathology laboratories are increasingly adopting whole slide imaging (WSI) and digital image analysis to improve diagnostic workflows. Before these innovative technologies can be implemented in routine practice, researchers must demonstrate that they provide the same level of accuracy and reliability as conventional microscope-based evaluation.
One of the most clinically important biomarkers evaluated using FFPE tumor tissue is Programmed Death-Ligand 1 (PD-L1), which helps identify patients who may benefit from immune checkpoint inhibitor therapies. PD-L1 testing has become a routine component of clinical practice across multiple cancer types, making consistent and reproducible assessment more important than ever.
📚 A study presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting and published in the Journal for ImmunoTherapy of Cancer demonstrated that digital whole slide image scoring is equivalent to conventional glass slide scoring for evaluating PD-L1 expression across 11 different tumor indications. BIOMEDICA CRO is proud to have contributed to this international research by providing high-quality FFPE tumor biospecimens and associated clinical data that supported the study’s validation process.
Why FFPE Tumor Biospecimens Are Essential for Digital Pathology Validation 🔬 🖥️
The COVID-19 pandemic highlighted the need for reliable digital solutions that would allow pathologists to evaluate tissue specimens remotely without compromising diagnostic accuracy. In response to this challenge, Agilent Technologies launched a large multi-tumor validation study to determine whether digital whole slide image (WSI) scoring could reliably replace conventional microscope-based evaluation of PD-L1 expression.
The study was performed using formalin-fixed paraffin-embedded (FFPE) tumor biospecimens representing 11 different tumor indications. Each specimen was stained with the PD-L1 IHC 22C3 pharmDx assay on the Autostainer Link 48 platform and evaluated using clinically established scoring algorithms — Tumor Proportion Score (TPS) and Combined Positive Score (CPS) — across six validated clinical cutoffs.
To ensure an unbiased comparison, three Agilent-certified pathologists independently evaluated every specimen twice: first using conventional glass slides under a light microscope and, after a minimum 14-day washout period, using high-resolution digital whole slide images generated with the Leica Aperio AT2 scanner and reviewed in Aperio ImageScope software. The investigators then compared the agreement between the two scoring modalities using positive percent agreement (PPA), negative percent agreement (NPA), and overall agreement (OA).
The results demonstrated that digital whole slide image assessment achieved equivalent performance to traditional glass slide evaluation across the validated PD-L1 scoring cutoffs. These findings support the use of digital pathology for reliable PD-L1 assessment and provide additional confidence for laboratories adopting digital workflows in precision oncology.
How BIOMEDICA CRO Supported an International FFPE Tumor Validation Study 🔍
High-quality biospecimens were fundamental to the success of this international validation study. To evaluate digital pathology across multiple cancer indications, Agilent Technologies collaborated with a global network of biospecimen providers capable of supplying well-characterized FFPE tumor biospecimens collected under appropriate ethical and quality standards.
BIOMEDICA CRO was proud to be one of the international contributors to this project by providing:
- high-quality FFPE tumor biospecimens from oncology patients
- associated anonymized clinical data supporting specimen characterization
The availability of diverse, clinically annotated biospecimens enabled researchers to evaluate digital PD-L1 scoring across multiple tumor indications under real-world conditions rather than relying on limited laboratory reference materials.
The study concluded that digital whole slide image scoring and conventional microscope-based assessment are interchangeable scoring modalities for evaluating PD-L1 expression using the PD-L1 IHC 22C3 pharmDx assay across the validated tumor indications and scoring algorithms. These findings represent an important step toward broader adoption of digital pathology, remote pathology workflows, and standardized companion diagnostics in oncology.
📄 Read the full publication: 36 Digital Whole Slide Image (WSI) scoring is equivalent to microscope glass slide scoring for evaluation of programmed death-ligand 1 (PD-L1) expression across multiple tumor indications.
Advancing Precision Oncology with High-Quality FFPE Tumor Biospecimens 🚀
At BIOMEDICA CRO, we support researchers by providing high-quality FFPE tumor biospecimens and associated anonymized clinical data for biomarker discovery, assay validation, companion diagnostics, and translational oncology research.
In addition, we offer a broad range of other biospecimen types to support diverse research applications, including:
Blood-derived samples:
- 🔬 Whole blood
- 🔬 Plasma
- 🔬 Buffy coat
- 🔬 PBMCs
- 🔬 Serum
- 🔬 Platelet layer, and more
Tissue samples:
- 🔬 FFPE blocks
- 🔬 Fresh frozen tissue
- 🔬 Viable frozen tissue (cryopreserved tissue), and more
Upon request, BIOMEDICA CRO also supports digital slide imaging by arranging high-resolution digital scanning of tissue slides, enabling researchers to incorporate digital pathology workflows into biomarker validation and image analysis studies.
Other biospecimens:
- 🔬 Whole urine, urine supernatant and urine cell pellets
- 🔬 Synofial fluid
- 🔬 Saliva
- 🔬 Stool samples, and more
Since 2017, we have managed both prospective biospecimen collection projects and access to our growing inventory of 45,000+ banked biospecimens, covering a broad range of oncology and non-oncology indications. Every project is tailored to the sponsor’s scientific objectives, from feasibility assessment and patient recruitment to biospecimen processing, quality control, storage, documentation, and international shipment.
✅ Ethics, Consent & Human Subject Protection
- All clinical materials are obtained exclusively following approval by an Institutional Review Board or Independent Ethics Committee (IRB/IEC)
- All donors provide informed consent and sign an Individual Consent Form prior to participation
- All clinical data are fully anonymized prior to sharing
- Strict adherence to international standards for the protection of human subjects
Whether your project focuses on early cancer detection, liquid biopsy, biomarker discovery, diagnostic innovation, drug development, or translational research, BIOMEDICA CRO is committed to delivering high-quality human biospecimens and reliable scientific support to help advance your research.
🌐 Interested? Explore our inventory of 45,000+ banked biospecimens by clicking here. Use available filters 🔍 to identify the most suitable samples and share your list with us so we can discuss tailored options for your study.
📩 Contact us: office@biomedica-cro.com.
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