ClarityDX Prostate: Improving accuracy in prostate cancer detection

A new prostate cancer test aims to deliver more precise testing for a leading cause of death among men while minimizing the risks of overdiagnosis.

Prostate cancer is the most common cancer, and one of the leading causes of cancer-related death, among Canadian men. Despite its prevalence, current screening methods—most notably the prostate-specific antigen (PSA) test—have been criticized for their lack of precision. PSA testing often leads to overdiagnosis and unnecessary biopsies, adding a strain on already overburdened healthcare resources and causing patients unnecessary stress and putting them through costly, sometimes harmful procedures. The challenge is to improve the accuracy of prostate cancer diagnosis while minimizing the risks associated with overdiagnosis. A promising Canadian innovation is poised to meet this challenge.

ClarityDX is a laboratory-developed test from Nanostics, an Alberta-based medical device and biotechnology company, that delivers a smarter, more targeted approach to prostate cancer screening. Unlike traditional screening methods, ClarityDX Prostate uses machine learning to combine clinical and blood-based biomarker data to predict the risk of aggressive, clinically significant prostate cancer with enhanced specificity. The result is a tool that improves accuracy without the need for invasive procedures.

In clinical validation studies, ClarityDX Prostate achieved an area under the curve (AUC) of up to 0.87, a strong indicator of its superior ability to distinguish between low- and high-risk cases. An AUC of 0.87 indicates superior diagnostic performance, far above the PSA test alone. Most impressively, when used with PSA testing, this innovation could reduce unnecessary biopsies by up to 47 per cent while maintaining a 95 per cent sensitivity rate for detecting aggressive cancer. In other words, it could greatly reduce both false positive and false negative PSA test results.

ClarityDX Prostate provides a more accurate risk assessment, leading to better decision-making about the need for further testing, like mpMRIs and biopsies.

Currently offered as a patient-pay test in Canada, Nanostics plans to build a comprehensive clinical and economic case for integrating ClarityDX Prostate into the standard of care nationwide. This includes launching a clinical utility study and undertaking a healthcare integration analysis. The roadmap for commercialization begins by incorporating the test in Alberta, followed by a national rollout.

The potential impacts for Canada are profound for this platform, which is receiving financial  support from Genome Canada. ClarityDX Prostate could significantly reduce healthcare costs by improving the efficiency of prostate cancer diagnosis, minimizing the need for specialist referrals, and shortening wait times for critical diagnostics. It supports a more resilient healthcare model, better suited to an aging population and rising cancer rates. It also promises better outcomes for patients through more accurate detection, ensuring earlier discovery for those at high risk and sparing low-risk individuals from unnecessary interventions.

Beyond the clinic, this initiative helps position Canada at the forefront of biotech development, taking advantage of the industry’s shift toward personalized, data-driven medicine. ClarityDX Prostate is part of the solution to ensuring timely, efficient and effective care for men.