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Molecular Biomarkers in Localized Prostate Cancer

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Sample requirement Clinical utility/ Intended use Comments FFPE tissue from a. prostate biopsy, or b. prostate tissue after RP a. Categorize patients into low/high risk to stratify patients into surveillance vs. treatment (and intensity of treatment). b. Post-prostatectomy for patients with adverse pathologic features to guide whether surveillance, adjuvant, or salvage therapy may be warranted. Evaluates mRNA expression levels of 22 genes from FFPE tissue. Generates score from 0–1.0. Tumor tissue from original biopsy in neutral buffered formalin prostatectomy specimens not accepted Biopsy-based likelihood of adverse pathologic features (grade group ≥3 or extracapsular extension). Identifies those who may benefit from surveillance vs treatment. GPS ranges from 0–100 based on mRNA expression of 17 genes across four pathways. FFPE tissue from: a. prostate tumor biopsy or b. prostatectomy specimens Aggressiveness of cancer: Provides 10-year risk of metastasis aer definitive therapy and disease-specific mortality under conservative management. mRNA expression of cell cycle progression genes is used to calculate the score. Clinical factors are subsequently added for risk assessment. Requires tissue collected with patented biopsy kit available from MetaMark Uses automated image recognition technolog y to determine likelihood of Grade Group ≥2 or stage ≥T3b. Expression of 8 proteins: Uses automated image recognition technolog y to generate a score from 1–100 indicating aggressiveness of prostate cancer. for by

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