Detailed Clinical Performance Data
Stockholm3 has been evaluated in large prospective and population-based screening studies. In total more than 90,000 men have participated in studies.
In a European screening cohort (N=12,670), Stockholm3 showed 90% sensitivity and 89% specificity for detecting aggressive prostate cancer (Grade Group ≥2 cancer). PSA ≥3 ng/ml showed 74% sensitivity and 90% specificity, while PSA ≥4 ng/ml showed 52% sensitivity and 95% specificity in the same cohort. [ref]
In men with PSA ≥1.5 ng/mL, Stockholm3 enabled detection of aggressive cancers while reducing unnecessary biopsies in men with elevated PSA levels compared to PSA-based referral pathways [ref]
Real-world use studies in Northern Europe reported stage migration and increased detection of aggressive prostate cancer following replacement of PSA-based screening strategies.
• Compared with national Swedish registry data, a stage migration at biopsy was observed for the cancers detected at the Capio Prostate Cancer Center (N=12,405) which showed 46% fewer low-risk diagnoses, a higher proportion (+41%) of intermediate-risk cancers, and 19% fewer high risk, advanced and metastatic cancers. [ref]
• In a cross-sectional, population-based health-system implementation study in Norway (N=4,784), replacement of PSA with Stockholm3 was associated with an 89% relative increase in detection of aggressive prostate cancer and a 26% reduction in detection of Grade Group 1 disease compared to the prior PSA-based pathway [ref]
Long-term follow-up analyses have explored associations between risk-based screening approaches and prostate cancer outcomes.
All results are derived from peer-reviewed publications.
Stockholm3 is investigational in the United States. Performance data presented here are derived from published studies conducted outside the U.S. and from North American cohorts.
The device is not cleared or approved by the U.S. Food and Drug Administration.