A3P Biomedical and BioAgilytix enter partnership for Stockholm3 in the USA
September 13, 2023
A3P Biomedical AB, a Swedish company specialized in advanced prostate cancer diagnostics, 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.
Prostate cancer is the most common form of cancer in American men. In 2023, it is estimated that 288,300 men will be diagnosed with, and 34,700 will die from, prostate cancer in the United States. Early detection and reduced overdiagnosis are crucial for improved treatment outcomes, decreased mortality, and better use of healthcare resources.
Recognizing the critical need for improved prostate cancer diagnostics, A3P Biomedical and BioAgilytix have joined forces to introduce Stockholm3 as a novel LDT in the US market. Stockholm3 has the potential of significantly advancing diagnostics and early detection, offering new possibilities for individuals facing a potential risk of prostate cancer.
"The partnership with BioAgilytix on Stockholm3 underscores our shared commitment to innovation. Our goal is to introduce Stockholm3 as an LDT that identifies men with increased risk of prostate cancer early and, at the same time, reduces unnecessary interventions. The US market is one of the largest in the world and would clearly benefit from implementing prostate cancer diagnostics that improves men’s health and quality of life,” says David Rosén CEO of A3P Biomedical.
“A3P Biomedical's dedication to precision medicine and patient-centered diagnostics fully aligns with BioAgilytix's commitment to advancing new biologic products that can change and save lives. Together, we seek to redefine healthcare by introducing breakthrough innovations that address unmet medical needs,” says Linda Robbie, PhD, COO of BioAgilytix.
Stockholm3 was recently mentioned as a biomarker test in the revised 2023 American Urological Association (AUA) guidelines for early detection of prostate cancer. The AUA guidelines cite a publication (Grönberg et al. 2015, Lancet Oncology) which has shown that Stockholm3 has a higher predictive accuracy compared to PSA alone, with the advantage of reducing unnecessary biopsies. The AUA guidelines further state that clinicians may use adjunctive biomarkers, such as Stockholm3, for men with elevated PSA levels as well as after a negative biopsy when the decision to perform a re-biopsy would be affected.
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 www.bioagilytix.com.
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.
Stockholm3 has been evaluated in clinical studies including more than 90,000 men. It is extensively tested in large population-based screening trials, as well as in real world clinical utility studies in primary care, as a reflex test to PSA at values 1.5-20 ng/ml. Benefits include the ability to reduce unnecessary MRIs, benign and Grade Group 1 prostate biopsies for men with elevated PSA, while simultaneously improving detection of clinically significant cancers in men with low or normal PSA values. 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.
Multiple Stockholm3 studies have been published in high-impact journals such as The Lancet Oncology, Journal of Clinical Oncology, and European Urology. 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. 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.
Press contact:
Cecilia Edström
cecilia.edstrom@a3p.com
+46 72 226 2328