Stockholm 3 commercially available in the USA
July 3, 2024
A3P Biomedical AB, a leading Swedish diagnostics company specializing in advanced prostate cancer diagnostics, and BioAgilytix, a global bioanalytical services provider, are excited to announce that Stockholm3 for early detection of prostate cancer is now commercially available as a Lab Developed Test (LDT) throughout the United States.
Prostate cancer is the most prevalent cancer among American men, with an estimated 288,300 diagnoses and 34,700 deaths in 2023. Addressing this critical health issue, A3P Biomedical and BioAgilytix joined forces in 2023 to redefine the standard of care for early detection of prostate cancer in the USA. Stockholm3, a novel blood-based LDT that significantly advances diagnostics and early detection, is now available throughout the USA providing new possibilities for individuals at potential risk of prostate cancer.
"The partnership with BioAgilytix has been instrumental in our mission to redefine the standard of care for early detection of prostate cancer in the USA. Stockholm3 has both higher sensitivity and higher specificity than the current standard PSA test. This means that aggressive prostate cancer can be detected earlier, when it is still treatable, while also reducing unnecessary procedures such as MRIs and biopsies. We believe there is a significant need and market potential for this unique test in the USA,” says Martin Steinberg, Executive Chairman of A3P Biomedical.
"The past year has demonstrated the power of partnership and innovation. A3P Biomedical's expertise in precision diagnostics, combined with BioAgilytix's capabilities in bioanalytical services, has enabled us to make significant advancements in prostate cancer diagnosis. We remain dedicated to introducing breakthrough innovations that address unmet medical needs and save lives," says Linda Robbie, Ph.D., COO of BioAgilytix.
As the partnership approaches its first anniversary, A3P Biomedical and BioAgilytix look forward to expanding the reach of Stockholm3, ensuring that more men across the USA have access to this life-changing diagnostic tool.
Stockholm3 is now available in BioAgilytix's catalogue and can be ordered throughout the entire USA. For more information on ordering the test please contact client services:
Email: clientservices@stockholm3.com
Phone: (919) 566 1501
For media and press related enquiries, please contact:
Cecilia Edström, acting CFO at A3P Biomedical
Email: cecilia.edstrom@a3pbiomedical.com
Phone: +46 72 2262328
About BioAgilytix
As a leading global bioanalytical services organization, BioAgilytix partners to deliver complex bioanalytical projects to pharmaceutical and biotechnology organizations across all drug development phases. The company maintains compliance to: GLP, GCP, GMP, and CLIA accreditations and provides diagnostic, pharmacokinetic (PK), immunogenicity, biomarkers, and cell-based assay services, from laboratories in Durham, North Carolina; Boston, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia; and Hamburg, Germany. For more information, please visit BioAgilytix | Global Leader for Bioanalytical Services.
About A3P Biomedical
A3P Biomedical is a company that specializes in advanced prostate cancer diagnostics. A3P’s main product, Stockholm3, is a clinically and commercially validated blood test for early detection and risk stratification of aggressive prostate cancer. A3P Biomedical is headquartered in Stockholm, Sweden. For more information, please visit www.a3p.com
About Stockholm3
Stockholm3 is a blood-based test, that runs a combination of protein biomarkers, genetic biomarkers and clinical information through an algorithm to find the probability of clinically significant cancer at biopsy. Using Stockholm3 leads to a more accurate risk assessment than the current PSA standard. Stockholm3 detects 40-90% more men with aggressive prostate cancer and, at the same time, reduces over-detection by 40-50% compared to PSA.
Stockholm3 has been evaluated in clinical studies including more than 90,000 men. The studies address both the specificity and sensitivity of Stockholm3 in multi-ethnic populations as well as health-economic benefits of implementing it in clinical care. Multiple studies have been published in high-impact journals such as The Lancet Oncology, Journal of Clinical Oncology, and European Urology. For more information about our clinical studies please visit www.a3p.com.
About prostate cancer
Prostate cancer is the most common cancer in men. In 2020, the global incidence of new prostate cancer cases was 1.4 million, and prostate cancer specific mortality 370,000. Global prostate cancer incidence and mortality is expected to rise by 100% and 85% respectively by 2040, driven by an ageing population.