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Routine Molecular Pathology Diagnostics in Precision Oncology.

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    Molecular pathology enables precise tumor characterization and targeted treatments, improving patient outcomes. Advanced genomic analyses are crucial for precision oncology, though validation is ongoing.

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    Area of Science:

    • Molecular pathology and genetics
    • Genomic characterization of tumors
    • Precision oncology

    Background:

    • Technical advances in molecular genetics allow precise genomic characterization of malignant tumors.
    • This has improved understanding of tumor biology and enabled molecularly stratified treatment strategies.
    • Molecularly targeted therapies are increasingly integrated into clinical practice.

    Purpose of the Study:

    • To review molecular pathology methods, their applications, challenges, and future directions.
    • To highlight the role of molecular diagnostics in guiding cancer treatment.
    • To discuss the integration of advanced genomic analyses in routine diagnostics.

    Main Methods:

    • A selective literature search of PubMed was conducted.
    • The search focused on molecular pathology techniques, indications, challenges, and future developments.
    • Evidence from randomized clinical trials and observational studies was considered.

    Main Results:

    • Molecular pathology methods like immunohistochemistry, in-situ hybridization, and DNA/RNA sequencing characterize tumors.
    • Molecularly stratified treatments, particularly in non-small-cell lung cancer, colorectal cancer, and breast cancer, improve progression-free survival.
    • Next-generation sequencing allows parallel analysis of multiple genes, streamlining diagnostics and biomaterial use.

    Conclusions:

    • Quality-assured molecular pathology assays for predictive biomarkers are widely available.
    • The integration of extensive genomic analyses into routine diagnostics is a future challenge for precision oncology.
    • Further validation is needed for widespread clinical application of large-scale genomic sequencing.