EDMONTON, Alberta, April 20, 2026

Nanostics Inc. has announced the publication of a peer-reviewed study validating its AI-powered ClarityDX® Prostate platform, demonstrating improved accuracy in predicting clinically significant prostate cancer and potentially reducing reliance on traditional diagnostic procedures such as MRI scans and digital rectal exams (DRE). The findings, published in npj Digital Medicine, highlight a major advancement in precision diagnostics and AI-driven healthcare innovation, offering a more efficient and patient-friendly approach to cancer detection.

AI-Driven Models Deliver High Accuracy in Cancer Prediction

The study evaluated four advanced ClarityDX Prostate risk models, including configurations with and without MRI and DRE inputs, all designed to assess the likelihood of aggressive prostate cancer using clinical and laboratory data combined with machine learning algorithms. Across multi-center cohorts spanning Canada, the United States, and Europe, the models demonstrated high predictive accuracy, with AUC values ranging from 0.81 to 0.88, indicating strong diagnostic performance.

Importantly, the base model—ClarityDX Prostate without MRI or DRE—maintained high accuracy, suggesting that traditional diagnostic steps may become optional rather than mandatory in certain clinical scenarios. This represents a significant shift in prostate cancer screening, where PSA testing alone often lacks specificity, leading to unnecessary biopsies and patient anxiety.

The results also showed that while MRI integration improves performance, the AI model still delivers clinically meaningful insights without it, enabling greater flexibility in diagnostic workflows. This adaptability supports broader adoption across diverse healthcare settings, from specialized oncology centers to community clinics.

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Reducing Unnecessary Biopsies and Improving Patient Outcomes

One of the most impactful findings from the study is the platform’s ability to reduce unnecessary prostate biopsies by up to 47%, while still detecting over 94% of aggressive cancers. This balance between sensitivity and specificity is critical in improving clinical decision-making and patient outcomes.

Prostate cancer remains one of the most commonly diagnosed cancers in men worldwide, and current diagnostic pathways often lead to overdiagnosis and overtreatment. By providing a quantitative risk score, ClarityDX Prostate enables physicians and patients to make more informed, personalized decisions بشأن whether to proceed with invasive procedures.

Additionally, the platform’s non-invasive and scalable design makes it suitable for widespread implementation, addressing gaps in access to advanced imaging technologies such as MRI. This is particularly relevant in resource-limited healthcare systems, where reducing dependency on expensive diagnostics can significantly improve care delivery.

Advancing Precision Medicine with AI and Digital Health

Nanostics’ ClarityDX® platform represents a broader shift toward AI-driven precision medicine, where data analytics and machine learning are used to enhance diagnostic accuracy and optimize treatment pathways. The platform integrates clinical variables, laboratory data, and advanced algorithms to generate personalized disease risk assessments, supporting earlier and more accurate detection of serious conditions.

The study’s validation across multiple international institutions reinforces the robustness and generalizability of the technology, positioning Nanostics as a key player in the rapidly evolving field of digital health and diagnostic innovation.

Furthermore, the ability to deliver high-performance diagnostic insights without mandatory imaging or physical exams aligns with the global trend toward minimally invasive, patient-centric healthcare solutions. As healthcare systems increasingly adopt AI-enabled tools, solutions like ClarityDX are expected to play a pivotal role in streamlining clinical workflows and reducing healthcare costs.

The validation of ClarityDX Prostate marks a significant milestone in AI-driven cancer diagnostics, demonstrating the potential to transform prostate cancer screening by reducing unnecessary procedures while maintaining high detection rates. With its flexible, scalable, and non-invasive approach, Nanostics is advancing the future of precision oncology and digital diagnostics, offering a powerful tool to improve clinical efficiency, patient experience, and healthcare outcomes.

Source: Nanostics press release