The biomarker profile consists of 3 microRNAs which may be readily assayed with Exiqon’s proprietary PCR technology using prostate cancer tissue obtained by radical prostatectomy. The published biomarker profile can group patients into “high” and “low” risk groups of which patients in the “low” risk group are expected to have a non-aggressive disease. More than half of the patients were categorized as being “low” risk with an accuracy of 80-89%.
The published biomarker profile works independently of current clinicopathological parameters and is therefore likely to add value to current clinical practice.
“At Exiqon, we share the vison of validating biomarkers together with the medical community to facilitate the implementation of personalized medicine. With the increasing cost of treating complex diseases such as prostate cancer there is a significant market need for tests that enable the medical community to focus the sparse resources on the relevant patients only” said Peter Mouritzen, VP Product Development, Exiqon A/S.
For several years, Exiqon and Aarhus University Hospital have been working together on identifying and validating novel prognostic biomarkers for prostate cancer. The study published in Oncotarget describes the prognostic biomarker profile validated in three independent cohorts.
“As many as 90% of the patients who today undergo operation for prostate cancer may avoid operation if biomarkers could provide information on the aggressiveness of the disease” said Torben Ørntoft, Professor Aarhus University Hospital.
Prostate cancer is the most frequent cancer among men, reflective of approximately 14% lifetime risk of getting prostate cancer. Fortunately, most prostate cancers are not aggressive. However, the lack of effective prognostic biomarkers results in significant overtreatment. Treatment of prostate cancer results in decreased life quality and comes at significant costs. Prostate cancer treatment costs between 20,000 USD and 140,000 USD per patient. With 1 million patients diagnosed with prostate cancer every year the market opportunity for a prognostic test amounts to approximately USD 750 million.
Exiqon is currently conducting analytic validation to document the robustness of the test. In parallel, additional patient cohorts are being recruited from Europe and the US to further strengthen the clinical validation. A commercial test may become available in 2017.