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.
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.