Blood Test Helps Clarify Prostate Cancer Risk After Elevated PSA

Laboratories and urology practices need better risk stratification that preserves sensitivity while helping identify patients most likely to have clinically significant disease. A newly launched blood-based test now aims to refine decision-making after an elevated PSA result and better inform the need for biopsy.

5Q Spectra (Vancouver, BC, Canada) introduced Prostate Dx, known as the Prostate Specific Biomarker (PSB) blood test, with a global debut scheduled at the Davos of Healthcare Summit in New York City on September 14, 2026. The launch caps a 15-year development effort to advance blood-based cancer diagnostics. The test is positioned for use following a raised prostate-specific antigen to deliver cancer‑specific biological information that can guide next steps in care.

Developed as a liquid biopsy, the PSB test is a blood-based molecular diagnostic intended to close the diagnostic gap between an elevated prostate-specific antigen and surgical biopsy. Reported diagnostic discrimination is an area under the curve (AUC) of 0.86, increasing to approximately 0.92 when combined with imaging and a clinical-intelligence artificial intelligence platform. At a selected high-sensitivity threshold, reported sensitivity is approximately 95% with the potential to eliminate up to 44% of unnecessary surgical biopsies.

The test is in use by urologists following an elevated prostate-specific antigen and is currently available as a Laboratory Developed Test (LDT) through Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories. An expert medical panel at the Davos of Healthcare Summit will examine early detection, clinical evidence, and the role of the PSB test in contemporary urologic oncology practice. The company reports investing more than C$85 million over 15 years in the underlying science and research and development.

“An elevated PSA certainly tells us when we should look further, but it was never designed to tell us whether prostate cancer is actually there. Our ambition has been quite simple: when a PSA level raises the alarm, our easy PSB blood test provides physicians and patients with better cancer-specific biological information about what that alarm means,” said Steve de Jaray, Co-Founder, Chairman and CEO of 5Q Spectra.

“Davos of Healthcare brings extraordinary medical science and clinical leadership to a global healthcare stage. And 5Q Spectra's new 'PSB' blood test is just that; addressing a critical diagnostic gap in today's medicine — helping men and patients beyond the uncertainty of a frightening elevated 'PSA' toward precise biological information that can guide the next step in care,” said Ransel N. Potter, Founder.

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