WALTHAM, Mass.--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, today announced the results of its collaboration with the Karolinska Institute on a groundbreaking clinical study, called Stockholm 3 (STHLM3), aimed at developing a more effective test for prostate cancer than using the prostate-specific antigen (PSA) alone. With an estimated 307,000 deaths worldwide in 2012, prostate cancer remains the fifth leading cause of death from cancer in men.1
The results of the clinical study, published today in The Lancet Oncology, 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.
Another landmark study published in The Lancet Oncology in 20142 concluded that PSA screening “is controversial because of adverse events such as over-diagnosis.” Over-diagnosis can lead to unnecessary and costly biopsies, while under-diagnosis can lead clinicians to miss an aggressive cancer altogether.
“The study authors put this all in perspective by pointing out that a 30 percent reduction in prostate biopsies would translate to 300,000 fewer procedures annually in the U.S.,” said Joseph Bernardo, president of Thermo Fisher’s clinical next-generation sequencing and oncology business. “So in addition to improving patient experience and outcomes, there is also the potential for significant healthcare cost savings.”
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.
1 GLOBOCAN 2012, Estimated Cancer Incidence, Mortality and
Prevalence Worldwide in 2012.
2 The Lancet Oncology volume 384, No. 9959, p2027–2035, December 6, 2014