A University of Alberta developed diagnostic test for prostate cancer is one step closer to being available for clinical use. Nanostics, a U of A spin-off company, has launched a clinical validation study for ClarityDX Prostate—a simple blood test that allows men to bypass painful biopsies to detect prostate cancer.
“A biopsy involves pushing 12 needles through an organ the size of a walnut. As you might imagine, it is a very uncomfortable and invasive procedure,” said John Lewis, CEO of Nanostics and the Alberta Cancer Foundation Frank and Carla Sojonky Chair in Prostate Cancer research at the U of A. “This new test requires just a simple blood draw. It couldn’t be easier.”
The diagnostic test measures millions of cancer cell nanoparticles in the blood and applies machine learning to recognize the unique fingerprint of aggressive, clinically-significant (which would benefit from treatment) prostate cancer. The clinical validation study will be carried out with blood samples from 2,800 men with elevated prostate-specific antigen (PSA) levels. Patient recruitment will be managed by the Alberta Prostate Cancer Research Initiative (APCaRI) and will start in Alberta at Calgary's Prostate Cancer Centre (PCC) and Edmonton's Northern Alberta Urology Centre (NAUC). Recruitment of men from the Yukon Territories will follow.
Previously, a 415-patient prospective clinical study established the validity of this novel liquid biopsy platform and determined it to be 40 per cent more specific than the standard prostate cancer blood screen test, PSA. Nanostics also very recently completed an intensive 2,000-sample stability study with the liquid biopsy blood test to determine the optimal collection and transportation conditions.
This new clinical validation study is part of the process towards meeting FDA and Health Canada requirements for an in vitro diagnostic test, which will allow Nanostics’ proprietary ClarityDX Prostate test to be provided to patients. The study will be conducted in partnership with DynaLIFE Medical Labs, a company that provides clinical services for over 2 million patients in its facility in Edmonton, as well as APCaRI at the U of A.
According to Lewis, the potential impact of the ClarityDX Prostate test is considerable; implementation could eliminate up to 600,000 unnecessary biopsies, 24,000 hospitalizations and up to 50 per cent of unnecessary treatments for prostate cancer in North America. Beyond an estimated cost savings to the health-care system of more than $1.4B per year, he expects the test will have a dramatic impact on the health-care experience and quality of life for men.
"We are extremely excited to be moving to the next phase of clinically validating the ClarityDX Prostate test", said Lewis, who is also a member of the Cancer Research Institute of Northern Alberta, "and we are grateful to all the support we have received here in Alberta to make this possible."
Funding for the clinical study comes in part from the Bird Dogs for Prostate Cancer Research, Motorcycle Ride for Dad, Prostate Cancer Canada, the Alberta Cancer Foundation, Alberta Innovates-ASBIRI program and the University Hospital Foundation Kaye Fund.