Bio-Techne Announces ExoDx Prostate Test Data Publication in the Journal of Prostate Cancer and Prostatic Diseases

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[{"type":"text","content":"MINNEAPOLIS, Oct. 13, 2021 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ:TECH) today announced that Exosome Diagnostics, a Bio-Techne brand, has published important clinical research in the journal Prostate Cancer and Prostatic Diseases, entitled Predicting high-grade prostate cancer at initial biopsy: clinical performance of the ExoDx (EPI) Prostate Intelliscore test in three independent prospective studies. In this pooled analysis from three independent prospective-validation studies and more than 1200 subjects, principal investigator Dr. Erik Margolis, Chief of Urology at Englewood Hospital and Medical Center, and colleagues demonstrated the ExoDx Prostate test, or EPI, can discriminate high-grade (≥GG2) from low-grade (GG1) cancer and benign disease. In the pooled cohort, the validated cut-off of 15.6 would avoid 23% of all prostate biopsies and 30% of \"unnecessary\" (benign or Gleason 6/GG1) biopsies, with a negative predictive value (NPV) of 90%. \nThe EPI test was previously independently validated in two prospective multi-site studies and the control arm of a clinical utility study that evaluated EPI in the biopsy decision process between physician and patient. This pooled analysis study consistently confirms that the ExoDx Prostate test effectively guides the biopsy-decision process independent of PSA and other standard of care factors. \nProstate cancer (PCa) is a leading cause of cancer death among men in the United States, with more than 3.6 million men living with prostate cancer. It is estimated that 249,000 newly diagnosed cases and 34,000 deaths will occur in 2021. Prostate needle biopsies are typically recommended for men with elevated serum PSA levels and/or a suspicious digital rectal exam (DRE) with added considerations based on family history, age, and race. The anxiety, pain, and potential complications associated with prostate biopsy are well documented. Furthermore, a large percentage of newly diagnosed prostate cancers are indolent, clinically insignificant, and with low metastatic potential. These cancers typically do not require definitive treatment and may be managed most effectively with Active Surveillance (AS). The low specificity of PSA which contributes to the high frequency of newly-diagnosed low-risk PCa suggests that 60–70% of men may be able to avoid biopsy.\nDr. Johan Skog, Chief Scientifi...

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