The laboratory-developed test is designed to assess cancer risk following an elevated PSA result and reduce unnecessary prostate biopsies.
5Q Spectra announced plans to introduce Prostate Dx, a prostate-specific biomarker (PSB) blood test, during the Davos of Healthcare Summit in New York City on Sept 14, 2026. The assay is designed to address diagnostic uncertainty following an elevated prostate-specific antigen (PSA) screening result by evaluating whether clinically significant prostate cancer is present.
According to the company, elevated PSA levels have long served as the primary clinical indicator for prostate cancer investigation, but PSA concentrations can also increase because of benign prostate enlargement, infection, inflammation, and other non-cancerous conditions. Consequently, patients frequently undergo repeated testing, imaging, surveillance, or invasive surgical biopsies that ultimately find no evidence of cancer.
“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,” says Steve de Jaray, co-founder, chairman, and CEO of 5Q Spectra, in a release. “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.”
Diagnostic Performance and Biopsy Reduction
Development of the assay represents 15 years of liquid biopsy research and an investment exceeding 85 million Canadian dollars, according to 5Q Spectra. In performance data reported by the company, the PSB blood test demonstrated an area under the curve (AUC) diagnostic discrimination of 0.86, which increased to approximately 0.92 when combined with imaging and the company’s artificial intelligence (AI) platform.
The company also reports that at a selected high-sensitivity threshold, the assay demonstrated approximately 95% sensitivity and the potential to eliminate up to 44% of unnecessary surgical biopsies.
“Davos of Healthcare brings extraordinary medical science and clinical leadership to a global healthcare stage,” says Ransel N Potter, founder of Davos of Healthcare, in a release. “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.”
Clinical Laboratory Availability
The Prostate Dx blood test is currently available to urologists as a laboratory-developed test through Clinical Laboratory Improvement Amendments-certified laboratories, according to the company.
At the upcoming summit, 5Q Spectra will host an expert panel featuring specialists in urology, radiation oncology, and prostate surgery to review the clinical evidence and discuss the role of the PSB test in clinical oncology workflows.
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