Collaboration on diagnostic test to improve prostate cancer screening
Thermo Fisher Scientific and Karolinska Institute reduce need for biopsies
The results of the clinical study pertain to the so-called STHLM3 model, which analyzes a combination of six protein markers, more than 200 genetic markers and clinical data (age, family history and previous prostate biopsies). The study, conducted between 2012 and 2014 with 58,818 men from Stockholm, Sweden, ages 50-69, showed a 30 percent reduction in biopsies without compromising the number of actual cancers diagnosed.
The Stockholm County Council, the main provider of healthcare in the Stockholm area, financed the STHLM3 prostate cancer study. Thermo Fisher provided the protein and genetic marker assays used in the clinical study.
“PSA can’t distinguish between aggressive and benign cancers,” said principal investigator Dr. Henrik Grönberg, M.D., professor of cancer epidemiology at the Karolinska Institute. “Today, men who don’t have cancer or who have a form of cancer that doesn’t need treating must go through an unnecessary, painful and sometimes dangerous course of treatment. On top of this, PSA misses many aggressive cancers. We therefore decided to develop a more precise test that could potentially replace PSA.” To date, no diagnostic test based upon the STHLM3 model has yet been approved for use by the U.S. Federal Drug Administration or other regulatory agencies outside the U.S.
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Grönberg, Henrik et al.; "Prostate cancer screening in men aged 50–69 years (STHLM3): a prospective population-based diagnostic study"; Lancet Oncology; 2015
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