4Kscore prostate cancer test recommended in US guidelines

The US’s National Comprehensive Cancer Network (NCCN) is to include 4Kscore® – the test offered as part of ProstateCheck in the UK – as a recommended test in the 2015 NCCN Guidelines for Prostate Cancer Early Detection.

The panel concluded that the 4Kscore, as a blood test with greater specificity over the PSA test, is indicated for use prior to a first prostate biopsy or after a negative biopsy to assist patients and physicians in further defining the probability of high-grade cancer. David Okrongly, Ph.D., President of OPKO Diagnostics, who developed the test, said: “We are pleased that the NCCN, an organization leading the way in the establishment of evidence-based guidelines for cancer diagnostics, is recommending the use of the 4Kscore test in the 2015 Prostate Cancer Early Detection Guidelines.”

The 4Kscore test is the only blood test that accurately identifies an individual patient's risk for high-grade, aggressive cancer. In arriving at their recommendations, the NCCN panel stated: “The challenge is to minimize immediate treatment (over-treatment) of indolent cancers by accurately characterizing the biology of the detected cancer. Identification and selective treatment of aggressive cancers should result in significant decreases in morbidity and mortality while limiting adverse effects on quality of life.”

In the UK the 4Kscore is not yet generally available on the NHS, where PSA testing remains standard, but Check4Cancer offers the test to the private and corporate markets through ProstateCheck.

The 4Kscore test has been studied on over 22,000 patients with results published in 12 peer-reviewed scientific publications. “Since its launch, I have been offering and using the 4Kscore test with my patients who have an abnormal PSA prior to a first prostate biopsy and before repeating a prostate biopsy after a negative biopsy,” said Dr. Dipen Parekh, Professor and Chair, Department of Urology at the University of Miami and principal investigator for the recently published United States multicentre validation study. “The 4Kscore provides me as a clinician with important information about my patient's individual risk for having aggressive prostate cancer and allows me to have an informed discussion with my patient about whether or not to proceed with a prostate biopsy or safely follow the patient.”

Vincent Gnanapragasam, consultant urological surgeon at the University of Cambridge and Addenbrookes Hospital, and Clinical Adviser to Check4Cancer, comments: “A key issue with the PSA test on its own has always been false positives and false negatives. This not only leads to unnecessary biopsies, but significant stress and anxiety among patients – especially if the limitations of the PSA test have not been fully explained to them. Recent data has shown that refinements and subtypes of PSA when added to total PSA (such as with the 4Kscore) can help improve the accuracy of cancer detection. I think it is almost inevitable that in future test combinations like these will be the norm. In the meantime, Check4cancer is the only organisation to offer one of these promising tests (the 4Kscore) in the UK.”