A new clinical validation study in the Värmland Region has been published in European Urology Open Science (1). The results of the study show that Stockholm3 leads to better prostate cancer diagnostics with a reduced number of examinations and lower resource consumption than current Swedish guidelines and can pave the way for future general screening of prostate cancer.
”The recently published study from Region Värmland further strengthens the clinical evidence for Stockholm3 and shows major improvements in prostate cancer diagnosis. Stockholm3 finds more aggressive tumors and enables a significant reduction in magnetic camera examinations and unnecessary biopsies. This has now been validated in clinical studies involving a total of over 75,000 men and reduces human suffering as well as costs and allocation of critical health care resources,” says David Rosén CEO at A3P Biomedical.
In brief the study shows the following results:
- Compared with current Swedish guidelines, Stockholm3 finds the same number of aggressive tumors, with a reduced number of magnetic camera examinations (-88 percent), reduced overdiagnosis (-18 percent) and fewer unnecessary biopsies (-15 percent).
- Compared with magnetic camera examinations, Stockholm3 finds more aggressive tumors (+7 percent), with a reduced number of supplementary magnetic camera examinations (-88 percent), reduced overdiagnosis (-23 percent) and fewer unnecessary biopsies (-39 percent).
Recruitment for the study was carried out in the Värmland Region between 2019 and 2020. Invitations were sent to 8,764 men, of whom 2,511 participated in the study and submitted a PSA test. Men with PSA ≥ 3 (N = 272) also performed a Stockholm3 test and magnetic camera examination. The study evaluated four different diagnostic strategies: i) National guidelines in Sweden until 2019, ii) National guidelines in Sweden from 2020, iii) Magnetic camera, and iv) Stockholm3.
The researchers behind the publication summarize the results by concluding that current guidelines have good susceptibility to aggressive prostate cancer, but with a high degree of overdiagnosis and unnecessary biopsies. Further, that Stockholm3 can significantly improve the precision of diagnostics and in the long run pave the way for general screening of prostate cancer.
To read the Region Värmland’s press release on the study, please refer to this link (in Swedish):
Studie i Värmland banar väg för bättre tidig diagnostik av prostatacancer – Region Värmland (regionvarmland.se).
(1) A Head-to-head Comparison of Prostate Cancer Diagnostic Strategies Using the Stockholm3 Test, Magnetic Resonance Imaging, and Swedish National Guidelines: Results from a Prospective Population-based Screening Study; Walden et al, European Urology Open Science 2022
For additional information, please contact:
David Rosen, CEO
Telephone: +46 10 1823325
Email: [email protected]
Stockholm3 is a blood test that combines protein markers, genetic markers, clinical data, and a proprietary algorithm, to predict the risk of aggressive prostate cancer at an early stage. In clinical practice, Stockholm3 finds 100 percent more aggressive prostate cancers and reduces 50 percent of unnecessary biopsies compared to current practice with PSA (2).
Stockholm3 has been evaluated in clinical studies with more than 75,000 men. Data from the latest pivotal study, a randomized study including 12,750 men, was published in The Lancet Oncology in 2021. Multiple studies have been published in high-impact journals, including a previous study with 58,000 men, published in The Lancet Oncology in 2015 (2).
Based on robust peer-reviewed clinical data, leading Nordic healthcare providers such as Capio S:t Görans Hospital in Sweden and Stavanger University Hospital in Norway have replaced PSA with Stockholm3. Patients benefit from a more precise test (increasing sensitivity and specificity) and healthcare providers can reduce the direct costs by 17 to 28 percent (2).
(2) Publications, results and clinical validation
About prostate cancer
Prostate cancer is the second most common male cancer, and the fifth leading cause of cancer related death in men worldwide. According to WHO, 1.4 million men were diagnosed with prostate cancer and 375,000 deaths were reported in 2020. Incidence of prostate cancer is expected to increase by 70 percent until 2040, driven by an aging population.
About A3P Biomedical
A3P Biomedical’s mission is to improve quality of life of men by radically increasing the precision in prostate cancer diagnostics. The company’s lead product is Stockholm3, a blood test for early detection of aggressive prostate cancer. Stockholm3 has been developed by scientists at Karolinska Institutet and validated in clinical studies including more than 75,000 men. A total of SEK 750 million has been invested in clinical research, product development and market validation activities of Stockholm3. A3P Biomedical is headquartered in Stockholm, Sweden. For more information, please visit www.a3p.com.