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Monthly Archives: June 2024

Research supporting ClarityDX Prostate published in Nature Digital Medicine

Published 26 June 2024

Development of an effective predictive screening tool for prostate cancer using the ClarityDX machine learning platform

M. Eric Hyndman, Robert J. Paproski, Adam Kinnaird, Adrian Fairey, Leonard Marks, Christian P. Pavlovich, Sean A. Fletcher, Roman Zachoval, Vanda Adamcova, Jiri Stejskal, Armen Aprikian, Christopher J. D. Wallis, Desmond Pink, Catalina Vasquez, Perrin H. Beatty & John D. Lewis

Abstract
The current prostate cancer (PCa) screen test, prostate-specific antigen (PSA), has a high sensitivity for PCa but low specificity for high-risk, clinically significant PCa (csPCa), resulting in overdiagnosis and overtreatment of non-csPCa. Early identification of csPCa while avoiding unnecessary biopsies in men with non-csPCa is challenging. We built an optimized machine learning platform (ClarityDX) and showed its utility in generating models predicting csPCa. Integrating the ClarityDX platform with blood-based biomarkers for clinically significant PCa and clinical biomarker data from a 3448-patient cohort, we developed a test to stratify patients’ risk of csPCa; called ClarityDX Prostate. When predicting high risk cancer in the validation cohort, ClarityDX Prostate showed 95% sensitivity, 35% specificity, 54% positive predictive value, and 91% negative predictive value, at a ≥ 25% threshold. Using ClarityDX Prostate at this threshold could avoid up to 35% of unnecessary prostate biopsies. ClarityDX Prostate showed higher accuracy for predicting the risk of csPCa than PSA alone and the tested model-based risk calculators. Using this test as a reflex test in men with elevated PSA levels may help patients and their healthcare providers decide if a prostate biopsy is necessary.

Nanostics Prostate Cancer Screening Test ClarityDX Prostate® accessible in British Columbia, Saskatchewan, and Ontario

EDMONTON, AB, June 5, 2024 /CNW/ – Nanostics Inc., a precision health company developing diagnostic tests with its ClarityDX® platform technology, is thrilled to announce today that men can now provide blood samples for its ClarityDX Prostate test at LifeLabs collection sites across British Columbia, Saskatchewan, and Ontario.

ClarityDX Prostate uses biological data, clinical information, and machine learning models to generate a risk score for aggressive prostate cancer, marking a significant advancement in prostate cancer screening. It provides critical support to men and their healthcare providers in making more informed decisions about whether to proceed with a biopsy or not following a high prostate-specific antigen (PSA) test result.

“We are very happy that we can now bring a powerful tool in prostate cancer screening to men and their healthcare providers in BC, Saskatchewan, and Ontario“, said Dr. John Lewis, CEO of Nanostics and Bird Dogs Chair of Translational Oncology at the University of Alberta. “When a doctor orders this test for their patient, they will receive accurate information about his risk of aggressive prostate cancer, helping make informed treatment decisions and avoid unnecessary invasive prostate biopsies.”

ClarityDX Prostate is available in British Columbia, Saskatchewan, and Ontario as a laboratory-developed test from Nanostics Clinical Laboratory in Edmonton, Alberta. In these provinces, tests are ordered, analyzed, and reported to the prescribing healthcare provider by Nanostics.

Go to www.nanosticsdx.com for more information and to order ClarityDX Prostate. Please direct all inquiries about the ClarityDX Prostate test to Nanostics via email at info@nanosticsdx.com or telephone 1-800-672-2027. ClarityDX Prostate is also available in Alberta from Nanostics as well as in Quebec from CDL Laboratories.

Click on the link below to read the full press release.

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