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The Challenge of Prostate Biopsy Decision Making

The Need for Improved Diagnostic Information

•   Provide more accurate information to improve decision making before having a prostate biopsy

•   Reduce the number of unnecessary biopsies, associated complications, and costs

•   Provide diagnostic information from a blood test; no requirement for biopsy tissue

The OPKO 4Kscore Test - Adding Clarity to Shared Decision Making

Elements of the 4Kscore Test

The 4Kscore test was developed by OPKO Lab and is performed by OPKO Lab at its CLIA-accredited laboratory facility. The 4Kscore Test relies on the measurement of four prostate-specific kallikreins in blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2). The blood test results are combined in an algorithm with patient age, DRE (nodules, no nodules), prior negative biopsy (yes/no). The result is a patient specific probability for finding a high-grade, Gleason score 7 or higher prostate cancer upon biopsy.

4Kscore Test: Rigorous Clinical Development

The 4Kscore test was developed by OPKO Lab and is performed by OPKO Lab at its CLIA-accredited laboratory facility. The biomarkers utilized in the 4Kscore Test are based on over a decade of research conducted by scientists at Memorial Sloan Kettering Cancer Center and leading research centers in Europe on over 10,000 patients. 1-8 The results have recently been replicated in a prospective blinded clinical study conducted at 26 urology centers in the United States on over 663 patients. 9 A recent health economic analysis demonstrated that use of the 4Kscore Test could result in annual savings approaching $1 billion in the US. 10

Data from the US Clinical Study

The biomarkers and algorithms utilized in the 4Kscore Test are based on over a decade of research conducted by scientists at Memorial Sloan Kettering Cancer Center and leading research centers in Europe on over 10,000 patients.

In a recently completed, prospective, blinded clinical study at 26 Urology centers in the US, the 4Kscore Test demonstrated a biopsy reduction potential of 42.9%.

•   The PSA test is not specific for prostate cancer. An elevated PSA can also be caused by benign prostate disease

•   The side effects of prostate biopsy (pain, bleeding, infection) make many men reluctant to have the procedure

•   Patient factors and medical history further complicate the decision for a prostate biopsy

To learn more about the 4Kscore Test,
call: 1 (877) 922-8364

To learn more, call: 1 (877) 922-8364

Personal risk for high-grade prostate cancer ... from a blood test

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