A new urine test shows high sensitivity and negative predictive value (NPV) for diagnosing high-grade prostate cancer and could reduce the need for prostate needle biopsies, researchers reported at the AUA annual meeting in New Orleans.
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A multicenter study led by researchers from New York-Presbyterian/Columbia University Medical Center, New York found a sensitivity of 92% and an NPV of 91% for the liquid biopsy test, EXO106. The test produced markedly better diagnostic results for high-grade prostate cancer (Gleason score >7) than standard of care—PSA in combination with age, race, and family history of prostate cancer.
EXO106 is an exosomal gene expression assay that evaluates messenger RNA in exosomes excreted in urine to detect cancer genes. The assay looks for three specific genes indicative of high-grade prostate cancer on exosomal RNA: ERG, PCA3, and SPDEF.
The authors prospectively enrolled 1,560 men from 25 urology practices nationwide who were 50 years of age or older, had equivocal PSA levels of 2.0 ng/mL to 10.0 ng/mL, had never had a prostate biopsy, and were scheduled for an initial biopsy for possible prostate cancer. They collected first-catch urine specimens not associated with digital rectal examination (DRE). Nine percent of the urine samples were excluded, leaving a training set of 499 patients and an intended-use population of 519 patients (median age 63 years, media PSA 5.12 ng/mL, 18% suspicious DRE, 28% family history of prostate cancer).
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