A simple blood test with a fast turnaround time to rule out prostate cancer with a high degree of accuracy.

• Results within 5-7 working days
• Detailed risk score report
• ONLY suitable for those with a PSA between 2 and 10 ng/mL

WHAT IS PROCLARIX?

Next-generation screening:

Proclarix is a next-generation blood test for prostate cancer screening, which combines total and free PSA, clinical data, and protein biomarkers in an algorithm, to predict your current risk of aggressive prostate cancer. It can be used by those with a PSA between 2 and 10 ng/mL, often referred to as the “grey area”, where it’s unclear if a raised PSA level indicates prostate cancer or not, and where a “normal” PSA doesn’t reliably rule out prostate cancer, which can be confusing and scary.

Proclarix provides clarity on these unclear PSA results by giving a more accurate and specific risk score for aggressive prostate cancer. A high-risk Proclarix score would indicate that you should go to the next stage of investigation – MRI. A low-risk score rules out prostate cancer with 95% accuracy. Proclarix can be used instead of a standard PSA blood test with no additional intervention required, with results available within 5-7 working days.

To determine whether you need a biopsy after an indeterminate MRI:

Proclarix can also be used after MRI, if the results are unclear. MRI scans are used in men with raised PSA values to identify masses in the prostate which indicate prostate cancer. A prostate biopsy is then performed to confirm if the mass is a cancerous tumour. However, around 40% of MRI scans are indeterminate, meaning the doctor is still not clear whether there is evidence of abnormality in the prostate or not. Without using Proclarix, all these men will undergo a biopsy, which has led to over 50% of biopsies performed being negative or clinically insignificant. This leads to overdiagnosis and overtreatment. To prevent this, a Proclarix blood test can be used after an indeterminate MRIs, to help a doctor decide whether there is need to perform a biopsy.

HOW DOES PROCLARIX WORK?

Proclarix has been CE-IVD-labeled based on the retrospective analysis of multiple subjects collected from two various cohorts. All subjects had a total PSA 2-10 ng/ml, a normal DRE, enlarged prostate volume, and a confirmatory TRUS-guided prostate biopsy. In this analysis, at 90% sensitivity, the specificity was 43% (versus 18% for %fPSA), with a negative predictive value of 95% for detecting a clinically significant prostate cancer. Proclarix is based on two novel biomarkers, thrombospondin 1 (THBS1) and cathepsin D (CTSD), combined with PSA and age. A software algorithm returns a risk score that can be used as an aid in the identification of clinically significant prostate cancer. It returns a Risk Score corresponding to the probability of detecting high-grade (Gleason score 7 or higher) prostate cancer based on a prostate biopsy.