Nanostics Launches Clinical Utility Study for Its AI-Powered ClarityDX Prostate Test to More Accurately Identify Aggressive Prostate Cancer

• The first patient was enrolled this month in a Nanostics-sponsored clinical utility study in Calgary to quantify the impact of incorporating ClarityDX Prostate into the standard of care for the early detection of prostate cancer.
• The randomized two-arm control study will recruit up to 1,074 men referred to two urology centres in Alberta.

EDMONTON, AB, April 23, 2025 /PRNewswire/ - Nanostics Inc., a precision health company developing diagnostic tests with its ClarityDX^® platform technology, has met a major milestone with the recruitment of the first patient into its recently launched clinical utility study (NCT06678828). The study will quantify the clinical and economic impact of incorporating ClarityDX Prostate into the standard of care for prostate cancer screening.

The Nanostics-sponsored study will recruit 1,074 patients from two Alberta Urology sites, with Dr. Eric Hyndman serving as the principal investigator at the Prostate Cancer Centre in Calgary and Dr. Adam Kinnaird serving as the principal investigator at the Kipnes Urology Centre in Edmonton.

ClarityDX Prostate was previously validated in a 3448-patient study that showed using ClarityDX Prostate as an adjunctive test after an elevated PSA result could more accurately identify men with aggressive prostate cancer sooner, leading to better outcomes while also minimizing the negative effects associated with overdiagnosis of the disease.

"We're excited to announce the first patient recruited in our ClarityDX Prostate clinical utility study," said John Lewis, CEO, Nanostics. "The study is designed to further support the use of ClarityDX Prostate as an additional tool for prostate cancer screening and support the wide-scale adoption of the test."

"If the results of the ClarityDX Prostate validation study hold true for this clinical utility study, a 47% reduction in unnecessary biopsies would be transformative for prostate cancer screening, both for the patient and the healthcare system," said Dr. John Dushinski, Chief Medical Officer for the Prostate Cancer Centre.

Prostate cancer affects one in six Alberta men, is the second leading cause of cancer death in men in North America, and 1 in 44 will die from it. Some prostate cancers grow slowly and are low risk, while others are aggressive and grow quickly. This disease often progresses with little to no symptoms, which makes early detection a critical component of screening because, when caught early, prostate cancer can often be treated successfully.

Including ClarityDX Prostate into the clinical care pathway for men with elevated PSA levels aligns with the Canadian Urological Association (CUA) recommendation to use adjunctive strategies to better stratify the risk of aggressive prostate cancer. North American and European urology associations also recommend that men with elevated PSA levels use adjunctive tests to better inform their decision to biopsy.

About Prostate Cancer Centre
Founded in 1999, the Prostate Cancer Centre (PCC) is a leading charitable organization committed to the early detection and treatment of prostate cancer, the advancement of men's health, and groundbreaking research in prostate and other urological diseases. Based at the Rockyview General Hospital in Calgary, the PCC provides comprehensive, personalized support to men and their families—before, during, and after treatment. Through community outreach, expert consultations, diagnostic services, education on treatment options, and access to cutting-edge research, the Centre remains a trusted resource for those affected by prostate cancer.

About Kipnes Urology Centre
The Dianne and Irving Kipnes Urology Centre (KUC) provides a state-of-the-art, single point of access to ambulatory urological services in Edmonton, Alberta. The KUC has both academic and clinical interests and is home to the only Urology Residency Training Program in Alberta. At KUC, patients are provided comprehensive care for prostate health and prostate cancer, including diagnosis, treatment, and research services to all men within Northern Alberta.

About Nanostics Inc.
Nanostics Inc. is a private Canadian company that develops and commercializes novel and noninvasive diagnostic tests. Its core technology, ClarityDX^®, uses advanced machine learning algorithms to create a disease risk score that predicts the presence of diseases. 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