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TEST:
Stockholm3

Type:
Laboratory Developed Test
Evidence

News

27d
Biomarker vs MRI-Enhanced Strategies for Prostate Cancer Screening: The STHLM3-MRI Randomized Clinical Trial. (PubMed, JAMA Netw Open)
P=N/A; In regions where access to MRI is lacking, the Stockholm3 test can aid in selecting patients for systematic prostate biopsy. ClinicalTrials.gov Identifier: NCT03377881.
Journal • Clinical
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Stockholm3
27d
Stockholm3 study awarded best abstract in the prostate cancer biopsy indication session at the 2024 European Association of Urology meeting (A3P Biomedical Press Release)
"The annual 2024 European Association of Urology (EAU) meeting was held in Paris from April 5 – 8. More sophisticated risk adapted prostate cancer strategies was a focus area, including six abstracts evaluating Stockholm3 in populations across Europe and North America. An abstract utilizing a baseline Stockholm3 score to predict biochemical recurrence after prostatectomy was awarded best abstract in the prostate cancer biopsy indication session."
Clinical data
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Stockholm3
1m
The impact of pre-biopsy MRI and additional testing on prostate cancer screening outcomes: A rapid review. (PubMed)
This review found that a combination of approaches, centred on the use of pre-biopsy MRI, may improve the detection of clinically significant cancers and reduce (i) the diagnosis of clinically insignificant cancers and (ii) unnecessary biopsies, compared with PSA testing and standard biopsy alone. However, the impact of such interventions on longer term outcomes such as prostate cancer-specific mortality has not yet been assessed.
Journal • Review • Biopsy
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Stockholm3
2ms
NorDCaP AS: STHLM3 AS NorDCaP - a Followup Study of Men on Active Surveillance of Prostate Cancer (clinicaltrials.gov)
P=N/A; Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
Trial completion date • Trial primary completion date
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Stockholm3
3ms
Stockholm3 evaluated for Swedish screening program (A3P Biomedical Press Release)
"In 2002, Region Stockholm and Region Gotland (the Region) began a joint three-year project by offering organised prostate cancer testing (OPT) to all 50-year-old men living in the Region. In 2024, an evaluation of the Stockholm3 test will be made in a research project at Karolinska Institutet in collaboration with OPT."
Clinical
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Stockholm3
3ms
The Capio Prostate Cancer Center Model for Prostate Cancer Diagnostics-Real-world Evidence from 2018 to 2022. (PubMed)
This study underscores the effectiveness of the protocol-driven diagnostic process at Capio PCC, enabling earlier detection of intermediate-risk prostate cancer and reducing the need for MRI assessments compared with standard prostate cancer care in Sweden. At the Capio Prostate Cancer Center, a novel diagnostic approach incorporating prostate-specific antigen, Stockholm3, magnetic resonance imaging, and targeted biopsies has been implemented to enhance prostate cancer testing and diagnosis in Stockholm, Sweden.
Real-world evidence • HEOR • Journal • Real-world
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Stockholm3
3ms
Stockholm3 leads to earlier detection of prostate cancer, improved precision, and better health economics (A3P Biomedical Press Release)
"In the latest edition of European Urology Open Sciences, the Prostate Cancer Center at Capio St. Göran’s Hospital is highlighted for its well-invested and structured model for prostate cancer diagnostics. This model, based on Stockholm3 combined with MRI and targeted biopsies has been shown to significantly improve the diagnostic outcome and health economics."
Clinical
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Stockholm3
4ms
Landmark Stockholm3 North American clinical trial presented at ASCO-GU (A3P Biomedical Press Release)
"The primary results of the landmark SEPTA trial, with over 2,000 racially and ethnically diverse biopsied men recruited in the US and Canada, were presented...at the ASCO-GU (The American Society of Clinical Oncology – Genitourinary Cancer Symposium) conference in San Francisco on January 26. The study found that use of the blood-based biomarker Stockholm3 was more accurate and could avoid up to half of unnecessary biopsies compared to current clinical practice. The findings were similar across all racial and ethnic groups."
Clinical data
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Stockholm3
4ms
HEOR • Cost-effectiveness • Cost effectiveness • Testing costs
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Stockholm3
5ms
The Capio Prostate Cancer Center model for prostate cancer diagnostics using Stockholm3, MRI, and targeted biopsies: Real-world evidence from 2018 to 2022. (ASCO-GU 2024)
The study demonstrates that the protocol-driven and diagnostic process at Capio PCC leads to an effective care, enabling earlier diagnosis of intermediate risk cancer and reducing the number of MRIs as well as incidence of overdiagnosis of low-risk cancers compared to the prostate cancer care in Sweden.
Real-world evidence • HEOR • Clinical • Real-world • Biopsy
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Stockholm3
5ms
Stockholm3 validation in a multi-ethnic cohort for prostate cancer (SEPTA) detection: A multicentered, prospective trial. (ASCO-GU 2024)
In an ethnically diverse population, Stockholm3 would significantly reduce unnecessary prostate biopsies and diagnosis of ISUP 1 cancer at a similar sensitivity of PSA for detecting clinically significant cancer. Clinical trial information: NCT04583072.
Clinical
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Stockholm3
5ms
Validation of the Stockholm3 Test for Detection of Prostate Cancer in the Swiss Population (clinicaltrials.gov)
P=N/A; Recruiting --> Completed | Trial completion date: Oct 2022 --> Oct 2023
Trial completion date • Trial completion
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Stockholm3
7ms
Prospective Multicenter Validation of the Stockholm3 Test in a Central European Cohort. (PubMed, Eur Urol Focus)
Our results show favorable clinical outcomes for the blood-based Stockholm3 biomarker test in a Central European patient cohort.
Journal
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Stockholm3
8ms
Prostate Biopsies Can Be Omitted in Most Patients with a Positive Stockholm3 Test and Negative Prostate Magnetic Resonance Imaging. (PubMed, Eur Urol Focus)
Systematic biopsies can be omitted in patients with a positive Stockholm3 test and a negative MRI when there is a volume cutoff in the test report. With no volume cutoff, biopsies can be considered with shared decision-making.
Journal • MRI • Biopsy
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Stockholm3
8ms
Clinical • HEOR • Real-world evidence • Real-world • Biopsy
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Stockholm3
8ms
NorDCaP AS: STHLM3 AS NorDCaP - a Followup Study of Men on Active Surveillance of Prostate Cancer (clinicaltrials.gov)
P=N/A, N=400, Recruiting, Karolinska Institutet | Trial primary completion date: Sep 2023 --> Dec 2023
Trial primary completion date
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Stockholm3
8ms
Stockholm3
8ms
A3P Biomedical and BioAgilytix enter partnership for Stockholm3 in the USA (A3P Biomedical Press Release)
"A3P Biomedical AB...and BioAgilytix, a global bioanalytical services provider, have entered a partnership with the aim of introducing Stockholm3, as a Lab Developed Test (LDT) designed to redefine the standard of care for early detection of prostate cancer in the USA."
Licensing / partnership
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Stockholm3