A urine test for prostate cancer

The prostate is a gland with the main function of producing seminal fluid containing elements essential to the survival, motility and quality of spermatozoa.

It has been observed that pathological situations, such as chronic inflammation or tumors, determine alterations in the physico-chemical characteristics of the liquid part of the ejaculate, influencing fertility.

When a cell in our body transforms into a tumor cell it goes through profound changes both structural and functional.

Since the majority of prostate cancers are classified as adenocarcinomas, i.e. tumors involving the glandular part, it is possible that the neoplastic transformation within the prostate could affect its secretory function.

The prostate cancer is an important public health problem, but to date there is no screening test to detect it early.

Innovative biomarkers

The prostate has a very specific function: it produces PSA to liquefy sperm and accumulates/secretes zinc to modulate this liquefaction, promoting correct sperm motility.

As prostate tissue begins to transform into cancer, the cells progressively lose this specific function.

The contents of the prostate can be channeled into the urethra, for example after a prostate exploration/massage, and then collected in the urine.

A urinary decrease in PSA and Zinc becomes a simple and non-invasive signal of possible tissue transformation.

Lower and lower levels suggest a greater likelihood that the transformation is due to the progression of a tumor within the prostate.

PSA is produced inside the prostate and physiologically a small portion passively leaks out and ends up in the blood.
When a tumor develops inside the prostate, the organ's architecture is compromised and larger amounts end up in the blood.
In reality, PSA production in the prostate has decreased. The organ simply retains a small amount.

ZenPSA-pro

The test

NIB biotec has developed the ZenPSA-pro, a rapid test to measure in a urine sample the presence of two soluble molecules, the PSA (normally measured in the blood) and the ZincEvaluating this combination of factors will allow the urologist to have the information necessary to give an accurate indication of the need for a biopsy to diagnose prostate cancer.

The ZenPSA-pro does not require dedicated instrumentation and can be used during a normal visit by the urologist.

ZenPSA-pro

How it works

The man who needs to have a prostate check-up can go to a urology clinic, in a hospital or directly to the doctor's office to carry out this test. Simply apply a drop of urine to the instrument and wait less than 10 minutes.

The ZenPSA-pro it is based on the measurement of two molecules.

When the test is positive the probability of having prostate cancer is high.

When the test is negative the chance of having prostate cancer is very low.

The ZenPSA-pro is not currently commercially available, but only for clinical investigations and is currently being evaluated in an observational study at the hospital San Luigi Gonzaga di Orbassano (Torino, Italy).

The test presents two reading windows for the two molecules (1 and 2). There are no bands in Window 1. In Window 2 you see a beige circle.

After loading the urine drop, only one band is visible in Window 1 and a pink/fuchsia circle is visible in Window 2. The test is negative.

Two bands are visible in Window 1, and an orange circle is visible in Window 2. The test is positive.

What science says

Some of the results obtained to date have been peer-reviewed by international scientific reviewers and have been published in important scientific journals and presented at european and american conferences.

  1. Detection of urinary prostate specific antigen by a lateral flow biosensor predicting repeat prostate biopsy outcome. Di Nardo F, et al., Sensors and Actuators B: Chemical 2020.
  2. Low Levels of Urinary PSA Better Identify Prostate Cancer Patients. Occhipinti S, et al., Cancers (Basel). 2021.
  3. Urinary Zinc Loss Identifies Prostate Cancer Patients. Maddalone MG, et al., Cancers. 2022.
  4. Urinary smart test for early detection of prostate cancer. AUA 2022 - Poster.
  5. Early detection of prostate cancer: an optimised urine smart test. AUA 2023 - Poster.
  6. Potential of a combined PSA-Zinc urinary test for the detection of prostate cancer. AUA 2024 - Poster.
  7. Urinary PSA-ZINC biomarker outperforms standard of care in early detection of prostate cancer. Amparore D. et al., Minerva Urol Nephrol, 2024.
  8. A rapid urinary test for combining PSA and zinc to enhance prostate cancer diagnosis: results from a prospective study. Prostate Cancer Prostatic Dis, 2025.
  9. A Rapid and Versatile Colorimetric Sensor for the Visual Detection of Zinc Ions in Urine and Drinking Water. Sensors 2026.

The benefits

The test ZenPSA-pro is based on prostate cancer biomarkers, more specific than the standard PSA test.

The use of this technology offers the possibility of improving the diagnosis of prostate cancer by offering the doctor a tool to more accurately identify men who need to carry out more in-depth tests for a real suspicion of prostate cancer.

This product will allow many men not to be subjected to invasive tests that they do not need, but above all it will allow procedures to be simplified and the time needed to carry out check-up tests to be shortened.

Thanks to its ease of use, the test can be carried out not only in a large equipped hospital, but also in a clinic or directly in a doctor's office.

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