Nanostics Launches Pivotal Study to Validate ClarityDX Prostate Diagnostic Test

Nanostics has started a pivotal clinical study in Canada to validate ClarityDX Prostate, a new blood test for the early diagnosis of prostate cancer. The company says the diagnostic tool has the potential to spare many men from unnecessary biopsies and treatments.

The study is part of the requirements needed to submit the diagnostic test for approval by the U.S. Food and Drug Administration (FDA) and Health Canada — which could eventually make it available to patients in the U.S. and Canada.

“We are extremely excited to be moving to the next phase of clinically validating the ClarityDX Prostate test,” John Lewis, CEO of Nanostics, said in a press release, “and we are grateful to all the support we have received here in Alberta to make this possible.”

ClarityDX Prostate is a noninvasive, liquid biopsy blood test designed to diagnose clinically significant prostate cancer, and help guide doctors on the decision to recommend patients for biopsy. The test is intended both for an initial diagnosis and for the active surveillance of patients to see if they progress to clinically significant prostate cancer.

The tool uses Nanostics’ ClarityDX platform, which combines advanced machine learning with detection of extracellular vesicles — small vesicles, or fluid-filled sacs, released from cells that may contain many disease-specific markers.

Extracellular vesicles have been found in nearly all biological fluids, and have attracted growing interest as potential targets for minimally invasive diagnosis of several illnesses.

A proof-of-concept study that sampled 415 patients previously showed that ClarityDX Prostate outperforms the standard prostate specific antigen (PSA) blood test – demonstrating a 40% greater accuracy for identifying men with clinically significant prostate cancer.

Nanostics says ClarityDX Prostate test could eliminate up to 600,000 unnecessary biopsies and 24,000 hospitalizations, and cut by half unneeded treatments for prostate cancer in North America.

The company stresses this will have a major impact on men’s care and quality of life — and potentially save an estimated $1.4 billion a year in healthcare costs.

The study now launched (NCT03957252) will clinically validate the test in 2,800 men with elevated PSA levels. Patients will first be recruited at Calgary’s Prostate Cancer Centre (PCC) and Edmonton’s Northern Alberta Urology Centre (NAUC), in Alberta, and later at centers in the Yukon Territories.

The study will be conducted by Nanostics in collaboration with the Alberta Prostate Cancer Research Initiative (APCaRI) at the University of Alberta, in the DynaLIFE Medical Labs.

Eric Hyndman, MD, PhD, from PCC, and Adrian Fairey, MD, from NAUC — both urologists and prostate cancer researchers — are the principal investigators.

A part of the funding for this study is provided by the foundations Motorcycle Ride for Dad and Alberta Cancer Foundation, the Alberta Innovates ASBIRI program, and the University Hospital Foundation Kaye Fund.