Accurate Diagnosis

In proof of concept clinical trials, our EV Fingerprint test detects clinically significant prostate cancer with the highest accuracy compared to similar tests in the market.

High Impact

Successful implementation of ClarityDX Prostate could eliminate up to 600,000 unnecessary biopsies and 24,000 related hospitalizations in North America each year.

Clarity in healthcare decisions

By differentiating between indolent and clinically significant prostate cancer, ClarityDX Prostate can guide physicians and patients through the decision process. As a result, men may be spared the adverse events of biopsy, prostate cancer surgery, radiotherapy and hormone therapy.

COST-EFFECTIVE

When ClarityDX Prostate gets to the market the test will save an estimated $1.4 billion in healthcare costs by reducing the number of prostate biopsies and unnecessary treatments such as surgery and radiation.

Clinical Utility

ClarityDX Prostate is designed to be a non-invasive and easily performed test with a small equipment footprint, these features will make this test ideal for large-scale population-based screening in medical clinics, worldwide.

Clinical Trial Phase

ClarityDX Prostate is in development and so currently has not received regulatory approval or clearance in any markets.

Validation of ClarityDX Prostate as a Reflex Test to Refine the Prediction of Clinically Significant Prostate Cancer

ClinicalTrials.gov Identifier: NCT03957252

This study is designed to determine the accuracy of the blood test ClarityDX Prostate to predict the results of prostate biopsies in men who have PSA (Prostate Specific Antigen) greater than 3 and no higher than 10 ng/mL.

Study Start Date: June 6, 2019

Estimated Study Completion Date: December 2021

Recruitment Status: Recruiting

Principal Investigators:

Adrian S. Fairey, MD, MSc, Northern Alberta Urology Centre, University of Alberta

Matthew E Hyndman, MD, PhD, Southern Alberta Institute of Urology, University of Calgary

Contacts:

Rume S Djebah, MBBS, MHA djebah@ualberta.ca

Catalina Vasquez, MSc catalina.vasquez@nanosticsdx.com

Collaborators

Alberta Prostate Cancer Research Initiative (APCaRI) DynaLIFE Medical Laboratories, Edmonton

Prostate Cancer Centre, Calgary

Northern Alberta Urology Centre, Edmonton

Alberta Cancer Foundation

Alberta Innovates Health Solutions

Bird Dogs

Motorcycle Ride for Dad

University Hospital Foundation -The Kaye Fund Competition

Study Description

The main objective of this study is to validate ClarityDX Prostate as a reflex test to PSA to refine the prediction of clinically significant prostate cancer in a prospective cohort of men to be recruited in Alberta, the Yukon, and in the United States when they are scheduled for a biopsy as a result of on an elevated PSA.

This prospective training and validation cohort study will consist of up to 2,800 consenting men in total, between ages 40-75 years old, without prior diagnosis of prostate cancer, who have been selected to undergo a prostate biopsy to rule out prostate cancer.

Inclusion Criteria:

1. Males between 40-75 years of age;

2. With and without family history of prostate cancer;

3. No prior prostate cancer diagnosis and who are referred to have a prostate biopsy;

4. PSA results > than 3ng/mL and no greater than 10ng/mL collected within 6m of enrollment;

5. Willing to permit Health Services agencies to disclose health-related information to study;

6. Undergoing a diagnostic prostate biopsy; and

7. Provided informed consent to participate in the study.