Fast, Painless, Precise: New Urine Test for Prostate Cancer Screening

Ms. Banzola, Mr. Eberli, you founded the spin-off ONTRACK Biomedical and are developing a test for the early detection of prostate cancer. Why is such a test needed?

Daniel Eberli: Prostate cancer is the most common cancer among men in Switzerland, with more than 7,000 new cases and about 1,000 deaths per year. This is why many men are advised to have the so-called PSA test to measure prostate-specific antigen (PSA), because a prostate tumor releases more PSA into the blood. However, this can sometimes lead to incorrect and unnecessary diagnoses. Elevated PSA levels in the blood can also be caused by something other than prostate cancer. So you cannot rely on the PSA value alone. These days, the “Stockholm3” test is also available, a genetic test that is more nuanced than PSA. However, if cancer is suspected, further tests such as an MRI scan and a tissue sample (biopsy) are indicated. This can be very tough for patients. What we have lacked so far is a simple test that provides us with meaningful information.

Irina Banzola: Then you also have the fact that men are generally so bad at coming forward for screening. People are also afraid of tests that involve MRI scans and biopsies. These are the reasons why we are working on developing a test procedure that estimates the risk of prostate cancer precisely and simply, and without any fuss. With our test, we can do something that is significant for men's health.

What prompted you to develop a new diagnostic test?

Banzola: I’ve always been interested in cancer research. After completing my Ph.D. in Bologna, I first worked on cancer during my postdoctoral years at the University Hospital Zurich. I find urology interesting, partly because my father had a problem related to this field. I then met Professor Eberli at the University Hospital Zurich, who is in charge of the Department of Urology. For me, as someone who is involved in pure research, it was critical to be involved in a clinical department, because you have contact with patients and can understand problems in a practical setting. Also, I always wanted to do something that patients would benefit from directly.

Eberli: Irina and I have discussed many medical questions and touched on various problems. This has led to our collaboration. For me, urology is one of the most fascinating areas of medicine, partly because we work with the latest technological developments, from laser technology to robotics, but also because our patients are really interesting. They are generally older men, well-developed personalities, who often impress with their special life wisdom. The exchange with them, also beyond medical topics, is always enriching and fascinating for me.

What exactly does your newly developed urine test do?

Eberli: Our test is intended for mass use and can be performed both quickly and with little effort. Mass screening can only really take two forms, with either breath or urine being analyzed. These require little effort and are painless for the patient. We opted for urine, as this contains lots of messenger substances from the prostate. The test we are developing is user-friendly and easy to work with: the man provides a urine sample, which is used to identify specific proteins that may raise the possibility of cancer. This test is very easy to perform – a family doctor could do it, for example – and then referred to the lab.
Our test has three thresholds that are very sensitive, so if the test is negative, 99.9 percent of the time the patient really does not have a tumor. The results are displayed in a simple color-based scheme: green, yellow and red. Green means the man does not have a tumor, yellow means he may have a low-grade tumor and should see his doctor, while red means he should undergo a biopsy.

How did you identify the decisive messenger substances?

Banzola: Urine contains many metabolites and other substances. The trick is to filter out the important biomarkers for prostate cancer. We achieved this, to sensational effect, in the course of a study. Once we had discovered two significant biomarkers using mass spectrometry, I thought that developing an ELISA (enzyme-linked immunosorbent assay) to measure these biomarkers in urine would be a very simple process. But it turned out to be extremely complicated, because urine can block antibodies, so the target proteins cannot be identified. A urine ELISA involves an immunological process that is used to identify specific molecules in urine samples. It is based on antibodies binding to specific antigens that may be present in the sample. For an ELISA to work in urine, the antibodies must have a very high affinity for the target protein and must not be pH-sensitive. Our team has great experience in developing such antibodies quickly and efficiently.

What were the reasons for creating a spin-off?

Eberli: We decided to set up a spin-off because we had reached a critical mass in terms of know-how: we had Irina with her skills in identifying proteins, the other colleagues in our team are antibody specialists and I'm the clinician. Together, we had the interdisciplinary brainpower to push ahead with the project. Our test also has another important advantage: it will be very cheap. Given all this, we decided two years ago to set up a company with the aim of bringing the test to market in the not too distant future.

Banzola: We managed to get some good results in an initial study, and this year we will have Daniel Eberli carry out a second, evidence-based study with a larger group of 300 patients from the Department of Urology at the University Hospital Zurich.

Apart from the affected men, who else might benefit from your test?

Eberli: If the ONTRACK test shows green, no further tests are needed. This helps to save valuable resources in patient care by avoiding unnecessary follow-up tests and reducing the number of costly procedures such as MRI scans and biopsies. This is our vision. With this simple test, we want to remove barriers and ensure that only men who actually have a problem are treated.

Once the definitive test is developed, who would handle distribution?

Banzola: We will probably enter a partnership with a major diagnostics firm, as these have powerful structures in place for marketing purposes. Ultimately, the goal is to give as many men as possible access to the tests and thus reduce the mortality rate.