A3P Biomedical AB, a Swedish diagnostics company focused on prostate cancer, and BioAgilytix, a global provider of bioanalysis, have entered into a collaboration to launch the Stockholm3 test as a laboratory-developed test (LDT) in the US market. This initiative aims to establish a new standard for the early detection of prostate cancer.
What is prostate cancer?
Prostate cancer is the most common form of cancer among men in the US. In 2023, 288,300 cases of prostate cancer are expected to be diagnosed in the country, resulting in 34,700 deaths. Early detection is critical to improving treatment outcomes, reducing mortality and making more efficient use of healthcare resources.
When prostate cancer is suspected, doctors have for many years carried out examinations using, for example, the PSA test, a blood test that is one of the first steps when cancer is suspected. Since A3P Biomedical's product Stockholm3 was launched on the market, it has become a worthy alternative that can detect aggressive prostate cancer at an early stage.
The collaboration between A3P Biomedical and BioAgilytix
A3P Biomedical and BioAgilytix are working together to introduce the Stockholm3 test to the US market, with the goal of significantly improving the diagnosis and early detection of prostate cancer. Stockholm3 offers a new opportunity for early detection of the disease, especially for those at risk.
David Rosén, CEO of A3P Biomedical, says that the collaboration with BioAgilytix on Stockholm3 is founded on a shared commitment to innovation. The aim is to launch Stockholm3 as an LDT to identify men at high risk of prostate cancer early while reducing unnecessary medical procedures. He emphasises that the US market, one of the largest globally, would benefit from advanced diagnostics that improve men's health and quality of life.
Linda Robbie, PhD, COO at BioAgilytix, highlights that A3P Biomedical's focus on precision medicine and patient-centred diagnostics complements BioAgilytix's commitment to developing biological products that can change and save lives. Together they strive to create a new standard of care by introducing innovative solutions that address previously unmet medical needs.
The Stockholm3 test was recently mentioned as a biomarker in the updated 2023 guidelines from the American Urological Association (AUA) for the early detection of prostate cancer. According to the AUA guidelines, based on a study (Grönberg et al. 2015, Lancet Oncology), Stockholm3 shows higher predictive accuracy than the PSA test alone and reduces the need for unnecessary biopsies.
The guidelines also suggest the use of complementary biomarkers such as Stockholm3 for men with elevated PSA levels or after a negative biopsy where the decision on a further biopsy would be affected.
The parties involved
About BioAgilytix
BioAgilytix is a leading global player in bioanalytical services, delivering complex projects in the pharmaceutical and biotechnology sector through all phases of drug development. With GLP, GCP, GMP and CLIA accreditations, the company offers a range of services including diagnostics, pharmacokinetics (PK), immunogenicity, biomarkers and cell-based assays from its laboratories in the US, Australia and Germany. More information is available at www.bioagilytix.com.
About A3P Biomedical
A3P Biomedical aims to improve men's quality of life by substantially improving the precision of prostate cancer diagnosis. Its main product, Stockholm3, is a blood-based test developed for the early detection of aggressive prostate cancer, created by researchers at Karolinska Institutet and validated in clinical studies with over 75,000 men. The head office is in Stockholm, Sweden. More information is available at www.a3p.com.
About Stockholm3
Stockholm3 is a blood test that combines protein and genetic biomarkers with clinical data to predict the risk of aggressive prostate cancer at an early stage. In clinical practice, the test has been shown to find 100 per cent more aggressive cases and reduces the number of unnecessary biopsies by 50 per cent compared with traditional PSA tests.
Stockholm3 has been validated in studies with over 75,000 men and has received recognition from the European Association of Urology (EAU) with the “Prostate Cancer Research Award 2022”. Several studies have been published in respected scientific journals, including an earlier study of 58,000 men in The Lancet Oncology in 2015. With strong scientific support, leading Nordic healthcare providers have begun replacing PSA tests with Stockholm3.
Region Värmland in Sweden has introduced organised prostate cancer testing with Stockholm3 for men aged 50–75, which provides a more accurate test while reducing direct costs by 17 to 28 per cent.
Sources
For more detailed information about Stockholm3's partnership in the US, read more among A3P's press releases.
