Nanostics, a precision health diagnostics company, unveiled positive data from a pre-biopsy clinical validation study of its ClarityDX Prostate test designed to improve the accuracy of detecting clinically significant prostate cancer in men that are at risk of the disease.
The ClarityDX Prostate test uses a proprietary machine-learning algorithm that combines data from two biological biomarkers and three clinical biomarkers to generate a risk score for clinically significant prostate cancer. The ClarityDX Prostate test is intended to be used as a reflex test for men with elevated levels of PSA, the current prostate cancer screening test, and is designed to help physicians and patients make a more informed decision to proceed with biopsy or not.
“We are extremely excited to announce positive results from the clinical validation study of the ClarityDX Prostate test in Alberta,” says John Lewis, CEO of Nanostics. “Implementing ClarityDX Prostate as a reflex test for men with elevated PSA levels will improve decision-making for men and their families, while providing substantial savings for healthcare systems and resulting in better health outcomes for men with prostate cancer.”
A total of 1,437 men between 40-75 years of age, with elevated PSA levels, no prior prostate cancer diagnosis, and who were referred for prostate biopsy, were recruited for this clinical study. Algorithmic risk models to predict prostate cancer or clinically significant (grade group ≥2) prostate cancer were generated using data from 1,036 men recruited at the Kipnes Urology Center in Edmonton, AB, and a site in Baltimore, U.S. These models were then tested in a validation cohort of 401 men recruited at the Prostate Cancer Center in Calgary, AB.
The ClarityDX Prostate test provided 94% sensitivity, 37% specificity, 49% positive predictive value, and 90% negative predictive value for predicting clinically significant (grade group ≥2) prostate cancer. The potential impact of the ClarityDX Prostate test is considerable; implementation could eliminate up to 37% of unnecessary biopsies and significantly reduce the number of unnecessary treatments for prostate cancer.
The results from the study are being submitted for peer-reviewed publication. Beyond the immediate cost savings to the healthcare system, the launch of the ClarityDX Prostate test will positively impact the overall healthcare experience and quality of life for men with prostate cancer.
The study was conducted in partnership with DynaLIFE Medical Labs and the Alberta Prostate Cancer Research Initiative (APCaRI) at the University of Alberta. Funding for the clinical study comes in part from The Bird Dogs, Motorcycle Ride for Dad, Alberta Cancer Foundation, Alberta Innovates, the University Hospital Foundation Kaye Fund, and the Frank and Carla Sojonky Chair in Prostate Cancer Research funded by the Alberta Cancer Foundation.