A3P Biomedical AB: Fast track publication of the STHLM3 MRI trial in The Lancet Oncology

A3P Biomedical AB announced that the publication of the STHLM3 MRI trial including 12,750 men has been fast tracked and is now published in the  renowned peer-reviewed scientific publication The Lancet Oncology1.

Results from the STHLM3 MRI trial, published in The Lancet Oncology, demonstrated that the combination of A3P Biomedical's proprietary blood test Stockholm3 with Magnetic resonance imaging (MRI) in a population based prostate cancer screening program decreases unnecessary biopsies by 74% compared to standard of care, while maintaining detection of significant cancer.

Furthermore, Stockholm3 reduces MRI procedures with 36% compared to PSA. These significant improvements may enable population-based prostate cancer screening.

"To get fast track publication in The Lancet Oncology in addition to winning first prize for best abstract at the recent EAU2 congress shows the significance of the data. A considerable  reduction in unnecessary biopsies as well as MRI procedures, which creates  bottlenecks, is a major improvement and provides the basis for accelerating the implementation of general prostate cancer screening. The evidence for the Stockholm3 test is based on clinical trials on more than 80,000 men", said David Rosén, CEO at A3P Biomedical.

The STHLM3 MRI-trial is a randomized screening-by-invitation trial, comparing the standard test PSA with the Stockholm3 blood test when used with MRI-targeted or systematic biopsies for prostate cancer detection. 12,750 men in the age of 50-74 years participated in the trial. Compared to standard screening by PSA and systematic biopsies, Stockholm3 combined with MRI-targeted biopsies was associated with 74% fewer unnecessary biopsy procedures and 69% fewer overdiagnosed low-grade cancers, while maintaining detection of significant cancer.

The AUC (area under the receiver-operating characteristic curve) for significant cancer in the standard biopsy arm was 0.76 (95%CI 0.72-0.80) and 0.60 (95%CI 0.54-0.65) for Stockholm3 and PSA, respectively, equalling a 27% improvement in AUC. Furthermore, by using Stockholm3 instead of PSA prior to MRI, the number of MRI procedures were reduced by 36% and the unnecessary biopsies were reduced an additional 18%.

Current standard of care starts with PSA testing. However, the poor specificity of PSA leads to unnecessary biopsies and overdiagnosis of low-grade prostate cancers, which has been a major barrier to the use of PSA in population-based screening.

"The healthcare providers in the Nordics that already transitioned to Stockholm3 have demonstrated that in clinical practice even better results are achieved than in clinical screening trials; 100% more aggressive cancers found, 50% reduction of unnecessary biopsies and 17 to 25% lower costs. A3P Biomedical is committed to making the Stockholm3 test available worldwide and look forward to work with current and new partners to improve men's health and quality of life", David Rosén further commented.

About Stockholm3

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. In clinical practice, Stockholm3 finds 100%more aggressive prostate cancers and reduces 50%of unnecessary biopsies compared to current practice with PSA (1).

Stockholm3 has been evaluated in clinical studies with more than 80,000 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 (1).

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 also benefit from direct cost savings of 17 to 25%(1).

(1) 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. In 2020, 1.4 million men were diagnosed with prostate cancer and 375,000 deaths were reported by GLOBOCAN. Incidence of prostate cancer is expected to increase by 70% 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 80,000 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.

1 Prostate cancer screening using a combination of risk-prediction, MRI, and targeted prostate biopsies (STHLM3-MRI): a prospective, population-based, randomised, open-label, non-inferiority trial; T Nordström et al, The Lancet Oncology 2021
2 European Association of Urology (EAU) Congress 2021

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