A clinical validation study carried out by Cleveland Clinic has shown that using a new blood test called IsoPSA could have avoided 47% of biopsies performed to identify prostate cancer.
Previous studies also revealed similar results (45.1%), indicating the use of IsoPSA in lowering the chances of over-detection and over-treatment of non-lethal prostate cancer.
Named Prospective Validation of the IsoPSA Assay for Detection of High Grade Prostate Cancer, the latest study compared the accuracy of IsoPSA with standard prostate-specific antigen (PSA) at predicting the overall risk of the cancer.
The multi-centre study was intended to validate the results from early studies where the new blood test was able to differentiate between high-grade and low-grade/benign cancer.
The capability of the test to identify high-grade cancer is expected to minimise unnecessary biopsies in patients who are at low risk of the disease.
Cleveland Clinic Glickman Urological & Kidney Institute chair Eric Klein said: “To be clinically useful, a biomarker must be both tissue-specific and cancer-specific.
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“While PSA is prostate-specific, it is not specific for prostate cancer, leading to diagnostic inaccuracy and too many unneeded biopsies.
“IsoPSA fulfils both the tissue- and cancer-specificity needed for a useful biomarker, and this validation study shows that it can more accurately detect high-grade cancer and reduce the rate of unneeded biopsies in patients at low risk of this disease.”
Developed by Cleveland Diagnostics, IsoPSA is a structure-based assay designed to analyse the structural changes of complex PSA.
Last year, Cleveland Diagnostics signed an exclusive licensing agreement with Genomic Health for the development and commercialisation of the test.