Our core technology, ClarityDX, is designed to diagnose disease from a simple blood test by combining a highly sensitive extracellular vesicle detection platform with advanced machine learning algorithms.
Our lead product currently in development, ClarityDX Prostate, is designed to be a highly accurate test to diagnose clinically significant prostate cancer and is positioned to emerge in the near future as a leading diagnostic tool to bring clarity to the healthcare decisions of prostate cancer.
ClarityDX Prostate is designed to accurately predict the presence of clinically significant prostate cancer and with the guidance of a physician can be used to inform the decision to biopsy.
ClarityDX Prostate can be used to monitor patients on active surveillance to detect the progression to clinically significant prostate cancer and inform the decision to biopsy.
The proof-of-concept EVMAP test was validated in a prospective clinical trial in partnership with the Alberta Prostate Cancer Research Initiative (APCaRI).
Our results showed a 40% increase in accuracy over the current Prostate Specific Antigen (PSA) testing.
In the validation prospective clinical trial, our diagnostic test achieved a > 0.8 AUC (Area Under the Curve, a measure of accuracy) for the identification of clinically significant prostate cancer, compared to a 0.58 AUC for the Prostate Specific Antigen (PSA) test, which is the current standard of care.
Extracellular Vesicle Machine Learning Analysis Platform for Diagnosis
Sector
Diagnostics and Liquid Biopsy.
Product
Prostate cancer blood test - currently in clinical trials - to identify patients at risk of having clinically significant prostate cancer.
AUC: > 0.8
Sensitivity: 98%
NPV: 98%
In proof of concept clinical trials, our EV Machine Learning Analysis Platform (EVMAP) detects clinically significant prostate cancer with the highest accuracy compared to similar tests in the market.
Successful implementation of ClarityDX Prostate could eliminate up to 600,000 unnecessary biopsies and 24,000 related hospitalizations in North America each year.
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.
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.
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.
ClarityDX Prostate is in development and so currently has not received regulatory approval or clearance in any markets.
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
Contact:
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.
The ability to detect and measure extracellular vesicles (EVs) is transforming the diagnostic landscape in a variety of fields such as immunology, neurology, cardiology, and oncology.
The ClarityDX platform technology is well positioned for future pipeline products including tests for screening, early diagnosis, complementary diagnosis, monitoring, and management for a large variety of diseases and medically-related events.
The research and development team at Nanostics continues to expand the ClarityDX platform through our own development and in partnership with others to include additional liquid biopsy diagnostic tests to improve patient care.
Development of the ClarityDX platform for use with many disease targets.
