Nanostics Announces Publication of a ClarityDX Prostate Study Validating New Algorithms with Improved Cancer Prediction that make MRI or DRE Optional

EDMONTON, AB, April 20, 2026 /PRNewswire/ - Nanostics Inc., a precision health company advancing diagnostic innovation through its ClarityDX^® platform, today announced the publication of a peer-reviewed study in npj Digital Medicine validating its AI-driven ClarityDX^® Prostate models for predicting aggressive prostate cancer.

Prostate cancer is one of the most commonly diagnosed cancers in men globally. Early detection and treatment of clinically significant prostate cancer saves lives. Men are screened for prostate cancer using the prostate-specific antigen (PSA) test, however, its low accuracy results in many men with no or low-risk cancer undergoing prostate biopsies or treatments unnecessarily. North American and European urology associations recommend that men with elevated PSA levels use adjunctive tests, including MRI, to better inform their decision to biopsy or not.

ClarityDX Prostate is designed as an adjunctive test for men with an elevated PSA result, providing an accurate risk score for aggressive prostate cancer so patients and their healthcare providers can make informed healthcare decisions. The study describes four ClarityDX Prostate models; ClarityDX Prostate, ClarityDX Prostate +DRE, ClarityDX Prostate +MRI, and ClarityDX Prostate +DRE +MRI. All four models utilize patient clinical features and laboratory tests to predict the patient's risk of aggressive prostate cancer

The risk models were developed and validated using contemporary, multi-site cohorts across six institutions in Canada, the United States, and Europe.  In head-to-head comparisons, ClarityDX Prostate demonstrated equal or superior accuracy relative to established risk calculators.

Highlights:

• High Accuracy Across Models: All four models achieved high accuracy (AUC) values ranging from ClarityDX Prostate with 0.81; ClarityDX Prostate +DRE with 0.82; ClarityDX Prostate +MRI with 0.82; and ClarityDX Prostate +DRE +MRI with 0.88.
• Scalable Across Care Settings: Designed for deployment in both community and specialized clinical environments.
• Improved Clinical Efficiency: Potential to reduce unnecessary biopsies by 47% while maintaining detection of more than 94% of aggressive cancers.
• Impact of MRI: Adding MRI features led to a substantial increase in model performance, with AUC values significantly higher than models without MRI.
• Digital Rectal Exam (DRE): While the results of a DRE contributed some value, the study showed that ClarityDX Prostate maintained a high accuracy without it, making it an optional input.
• Competitive Differentiation: Matches or exceeds the accuracy of existing risk assessment tools.

"Our ClarityDX Prostate models provide versatility while maintaining high accuracy, which is important for men looking for optionality regarding a DRE or MRI" said John Lewis, CEO of Nanostics. "We are committed to providing healthcare providers with accurate and accessible tools to aid decision-making, reducing the burden of unnecessary procedures, and ultimately improve patient outcomes."

The study was supported by funding from the Alberta Cancer Foundation, Bird Dogs, NRC-IRAP, Alberta Innovates, Ride for Dad and the Prostate Cancer Fight Foundation, and Prostate Cancer Canada. John Lewis, PhD, holds the Bird Dogs Chair in Translational Oncology funded by the Alberta Cancer Foundation in the Faculty of Medicine & Dentistry at the University of Alberta.

For partnership opportunities or to learn more, visit www.nanosticsdx.com or contact [email protected].

Citation: Paproski, R.J., Kinnaird, A., Hyndman, M.E. et al. Predicting clinically significant prostate cancer with or without digital rectal exam and MRI data using ClarityDX Prostate models. npj Digit. Med. (2026). DOI: 10.1038/s41746-026-02642-1 PMID: 41998222.

About Nanostics Inc.
Nanostics is a Canadian company that develops and commercializes novel and noninvasive diagnostic tests. Its core technology, ClarityDX^®, uses advanced machine learning algorithms to create disease risk scores. ClarityDX is applicable to a wide range of cancers and other diseases. Nanostics' lead product, ClarityDX Prostate^®, is a test that improves the accuracy of detecting clinically significant prostate cancer. Read more at: www.nanosticsdx.com. Follow Nanostics on LinkedIn, YouTube, Facebook, and Instagram.

SOURCE Nanostics