What it is: ex-vivo testing evaluates drug sensitivity of patient-derived cells/tissue models (often including organoid-style or other viable platforms) to identify relative response patterns across therapies.
Why clinicians use it:
What the literature suggests: systematic reviews and translational evidence generally show a positive association between ex-vivo drug sensitivity and clinical outcomes—while also emphasizing methodological variability and the need for standardization. (mdpi.com)
Important clinical note (transparent): ex-vivo testing is not a guarantee of response. Results should be interpreted in the context of performance status, line of therapy, guideline standards, and tumor biology.
What it is: targeted panels or broader sequencing to identify actionable alterations and refine diagnosis, prognosis, and therapy selection.
Why specimen quality matters: fixation and preanalytic handling can impact nucleic acid integrity; professional guidance highlights controlling cold ischemia and fixation windows to preserve biomarker reliability. (College of American Pathologists)
Guideline-aligned integration: molecular testing standards (example: lung cancer) provide clear recommendations for clinically relevant targets and testing strategies, often supporting NGS approaches where appropriate. (CAP Documents)
Common biomarker pathways supported by preserved tissue:
Guidelines: CAP provides specific guidance for MMR/MSI testing to inform immune checkpoint inhibitor therapy, including assay selection considerations. (College of American Pathologists)
Why cryopreservation can help: viable tissue expands optionality for future immune-oncology research and some advanced assays aimed at tumor ecosystem characterization. (PMC)
Concept: personalized (often neoantigen-targeted) vaccines use tumor sequencing + computational selection to generate patient-specific vaccine constructs.
Clinical evidence (early-stage): foundational studies demonstrate feasibility and immunogenicity of personal neoantigen vaccines in melanoma, supporting continued development and trial expansion. (PubMed)
Why tissue strategy matters: personalized vaccine pipelines typically require high-quality tumor material for sequencing and antigen discovery.
SpeciCare supports trial readiness by aligning tissue handling with protocol requirements and helping clinicians avoid last-minute re-biopsy barriers when eligibility depends on biomarker confirmation.
Best-practice alignment: Specimen stewardship and repository standards emphasize quality systems, traceability, and consistency—key for trials and translational research partnerships. (PMC)
