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The success of precision oncology depends heavily on identifying and validating reliable biomarkers. From predicting drug response to monitoring resistance, biomarkers shape treatment strategies and guide clinical decision-making. However, robust biomarker discovery requires access to high-quality, reproducible specimens. This is where the ffpe tissue block plays a pivotal role.
In our previous article, we introduced the basics and advantages of ffpe tissue samples. In this part of the series, we explore how FFPE technology accelerates biomarker discovery and validation, with real-world examples in lung and colorectal cancer research.
Biomarkers are measurable indicators—genetic, protein, or molecular—that provide insights into tumor biology. They are used to:
Predict therapy response (e.g., EGFR mutations in NSCLC)
Determine prognosis (likelihood of recurrence or survival)
Guide treatment selection (targeted therapies vs immunotherapies)
Track resistance mechanisms
Without validated biomarkers, targeted therapies cannot reach their full potential. FFPE tissue samples for biomarker discovery provide the backbone of these studies by offering preserved tumor material annotated with clinical metadata.
Biomarker discovery requires analyzing patterns across many patients. NSCLC ffpe tissue blocks with EGFR mutations or CRC FFPE blocks with MLH1, PMS2, MSH2, and MSH6 allow researchers to validate findings in hundreds of cases under consistent conditions.
FFPE tissue samples can be analyzed using a wide range of technologies, such as:
Immunohistochemistry (IHC): Protein expression markers like PD-L1
PCR and qPCR: Gene mutation detection (e.g., KRAS, BRAF)
Next-generation sequencing (NGS): Comprehensive mutational profiling
FISH: Structural rearrangements such as ALK or ROS1 fusions
This versatility makes ffpe tissue blocks uniquely suited for biomarker pipelines.
Since FFPE samples can be stored for decades, researchers can retrospectively correlate biomarker status with long-term survival and treatment outcomes. This is particularly valuable in diseases like breast or colorectal cancer, where archival material informs today’s clinical guidelines.
EGFR mutations are predictive biomarkers for response to tyrosine kinase inhibitors. By studying egfr-positive ffpe tissue samples, researchers confirm drug efficacy, resistance pathways, and patient stratification.
Loss of MLH1, PMS2, MSH2, or MSH6 is a hallmark of mismatch repair deficiency. CRC ffpe tissue blocks annotated with these IHC results are used to identify microsatellite instability (MSI), which predicts response to immunotherapy.
IHC staining of ffpe tissue blocks helps determine PD-L1 levels, guiding eligibility for immune checkpoint inhibitors across multiple cancers.
Consistency: All samples processed under identical lab conditions
Accessibility: Large libraries of ffpe tissue samples are available for global research collaborations
Cost-effectiveness: One block can generate dozens of sections for multiple studies
Clinical Relevance: Annotated data (age, gender, treatment history) enhances translational value
Biomarker discovery is only the beginning. The next frontier is molecular profiling, where researchers go beyond single markers to map entire genomic and proteomic landscapes from ffpe tissue blocks.
In our next article, we will explore how FFPE samples support advanced molecular profiling, enabling precision oncology and shaping the future of cancer treatment.