Elevated PSA?

Proclarix^®
next generation blood test for prostate cancer

Non-invasive

Diagnosis without the risk, pain or costs of tissue biopsies

Fast

Saves time by using the same blood sample as PSA testing

Precise

Proclarix reliably identifies high-grade prostate cancer

Accessible

Proclarix is easily performed at your local laboratory

Clear answers on unclear PSA results

Today, the initial step to diagnose prostate cancer is by testing PSA together with a digital rectal examination (DRE). The PSA test is a well-established prostate-specific marker that measures the concentration of PSA molecules (Prostate-Specific Antigen) in a blood sample. A high level of PSA can be a sign of prostate cancer. Therefore, clinical guidelines recommend a confirmatory prostate biopsy, if PSA > 3 ng/ml. But PSA levels can also be raised for many other reasons including infections, prostate stimulation, vigorous exercise or even certain medications. PSA results are confusing for many patients and even physicians. Patients are sent for time-consuming and anxiety-causing additional examinations, especially when a biopsy is being considered. Currently, over 50% of biopsies with elevated PSA are negative or clinically insignificant. This means overdiagnosis and overtreatment that impacts the physician's routine, our healthcare system, and the quality of patient's lives.

Proclarix Brochure

Just one blood sample away from clarity

Proclarix is an easy to use simple protein-based blood test that can be done with the same sample as the PSA test. No additional intervention is required with results becoming quickly available. Any local diagnostic laboratory can easily add this affordable multiparametric test to the existing infrastructure.

Why should you use Proclarix?

Patient

Immediate clarity after first doctor-visit: relief if no or insignificant cancer vs. immediate referral

Less anxiety and time spent on potential prostate cancer diagnosis

Physicians

Clear decision support for patients with elevated PSA: relief or immediate referral

Works as a reflex test with the same blood sample as PSA

Improved patient management and patient satisfaction

Healthcare system

Strong health economic benefits thanks to early rule out of patients with no or non-significant cancer

Fewer complications (e.g., bleeding, infections)

How Proclarix clears the grey zone

Patients with a PSA level between 2 and 10 ng/ml are in a diagnostic grey zone. In these cases, the doctor faces an inconclusive situation without having sufficient information to decide whether to continue investigating or discharge the patient. Unclear results cause patients anxiety and require both additional time spent on health care procedures and unnecessary biopsies. Proclarix helps doctors and patients with PSA levels in the grey zone. Its Proclarix Risk Score delivers clear and immediate diagnostic support for further treatment decisions.

Clinical Evidence for Proclarix

Proclarix has been CE-IVD-labeled based on the retrospective analysis of 955 subjects collected from two different hospital 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, i.e., a Gleason score ≥7 (Klocker H, Golding B, Weber S, Steiner E, Tennstedt P, Keller T, Schiess R, Gillessen S, Horninger W, Steuber T. BJUI Compass. 2020;1:15-20). Using Proclarix reduces the number of biopsies needed to reliably detect clinically significant prostate cancer.

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