Overview
Reducing the need for prostate biopsies by predicting the risks of high grade prostate cancer (HGPrCa) using biomarkers from semen
Preventing 6,000 unnecessary biopsies: A Canadian innovation in prostate cancer diagnosis
New prostate cancer testing targets more precise, less invasive diagnosis of the most diagnosed cancer among men in Canada.
Every year, around 100,000 men in Canada undergo prostate biopsies based on elevated PSA levels or abnormal prostate exams. They face an uncomfortable procedure that comes with risks of its own and yet only 20 per cent of those biopsies reveal high-grade prostate cancer, the kind that is clinically significant and requires treatment.
Healthcare providers need a reliable, non-invasive test to identify who needs a biopsy and who does not. Apart from MRI, there have not been non-invasive tests that can be used to reduce biopsy rates.
A genomics-driven solution
This is where FlowLabs, a Canadian diagnostic company, identifies a significant opportunity, working in collaboration with the Murray Koffler Urologic Wellness Centre and the Lunenfeld-Tanenbaum Research Institute at the Mount Sinai Hospital, the Donnelly Centre for Cellular and Biomedical Research at the University of Toronto, and the Ontario Institute for Cancer Research. FlowLabs is preparing to validate a new test that uses semen samples to identify high-grade prostate cancer. The test measures biomarkers—two amino acid metabolites and two microRNAs – that can accurately differentiate serious prostate cancer cases from low-grade prostate cancer or the absence of disease.
First, FlowLabs will confirm the validity of the test using samples from 250 men who have already had biopsies. Then, the lab will develop an algorithm that combines semen biomarker levels and other clinical data, such as PSA levels and MRI results, to predict the risk of high-grade prostate cancer more accurately. A large-scale clinical trial of 700 men undergoing biopsies at seven clinical centers across Canada will test the algorithm’s usefulness and performance in the real world.
FlowLabs is ideally equipped for this project. Based in Ontario, it has Canada-wide logistics in place for receiving samples at its central licensed laboratory. If successful, the test could allow FlowLabs to expand its workforce by the creation of as many as 50 new highly skilled positions as it taps into a North American market that is worth up to $300 million for such a test. In the next three–five years, this semen-based test could prevent up to 6,000 men from unnecessary biopsies, save the health system $8M annually, and position Canada as a global leader in non-invasive cancer diagnostics.
This test is expected to be highly attractive to patients, two-thirds of those under the age of 65 who prefer providing a semen sample to a blood sample. It has superior accuracy to other commercial tests.
FlowLabs will engage key opinion leaders and healthcare providers to support the test’s adoption, focusing on establishing reimbursement agreements with provincial healthcare systems and private insurers. The test will be initially launched across Canada, with subsequent expansion internationally.
Genome Canada’s investment in this project, and initial seed funding from the Koffler Foundation, will help unlock its potential to revolutionize prostate cancer diagnosis in Canada and globally.