New liquid biopsy test from Exosome avoids many unpleasant prostate biopsies

Interview with Mikkel Noerholm, Head of European Operations Exosome Diagnostics

The test from Exosome Diagnostics is used in patients with suspected prostate cancer. The physician thus has a concrete decision-making aid as to whether a biopsy really needs to be performed.

About 78,000 men died from prostate cancer in the European Union in 2020, making it the third leading cause of cancer death in men after lung and colorectal cancer. According to figures presented in the Annals of Oncology deaths are declining in Western Europe but increasing in Eastern Europe.

The age-specific mortality rate (ASR) from prostate cancer varies quite a bit across Europe. Among the 5 most populous countries, it is lowest in Italy, at 5.8 per 100,000 inhabitants. This is followed by Spain with (7.2/100,000) and France with (7.3/100,000). In Germany and the United Kingdom, ASR is 11 per 100,000 men. The highest ASR is in Poland with 14.7/100,000 men.

Prostate cancer diagnosis can be a frightening time for men, especially during a time when appointments and procedures have been cancelled, and COVID-19 has upended our normal way of practicing, leaving both patients and physicians scrambling for answers.

The current gold standard for prostate cancer diagnosis – needle biopsy – often lacks a true reflection of the molecular profile of the tissue given sampling error, complex tumor heterogeneity as well as 25 percent to 50 percent false negative rates. Further, the relative lack of PSA specificity for prostate cancer has led to over-diagnosis of clinically insignificant prostate cancer.

Exosome Diagnostics now offers a liquid biopsy test in Europe that will avoid many unpleasant and potentially unnecessary biopsies. IZB Biotech News interviews Mikkel Noerholm, Head of European Operations Exosome Diagnostics – a Bio-Techne company.

Mikkel Noerholm Exosome

Mikkel Noerholm, Head of European Operations Exosome Diagnostics

IZB Biotech News: Detecting prostate cancer without a biopsy – How does it work?
Mikkel Noerholm: To finally diagnose prostate cancer, a tissue biopsy has to be performed. However, this is an extremely unpleasant and painful procedure that men should only have to undergo if there is a high medical need for action. Exosome Diagnostics has developed a non-invasive urine test that can determine the risk of clinically significant prostate cancer. From a simple urine sample, we can help patients and doctors decide who really needs a biopsy and who can avoid it.

IZB Biotech News: How can you detect cancer in urine?
Mikkel Noerholm: Exosome’s test is the world’s first diagnostic test in clinical practice to use biomarkers derived from exosomes and extracellular vesicles. Exosomes are vesicles approximately 30 to 90 nm in size that are released from cells in the body into the surrounding environment and end up in biofluids like blood and urine. They are formed by many different cells, including lymph cells, blood platelets and tumor cells, and contain a wide variety of macromolecules such as proteins and genetic material. This is why we examine urine exosomes when prostate cancer is suspected.

IZB Biotech News: When should such a test be performed?
Mikkel Noerholm: Our test is intended for patients under suspicion of having prostate cancer, due to a slightly elevated prostate-specific antigen (PSA) level of 2-10 ng/ml. In this situation, the Exosome test can serve as an aid for the physician and the patient in the decision-making, whether a biopsy really needs to be performed.

IZB Biotech News: What does daily practice look like with the new test?
Mikkel Noerholm: Understandably, it is associated with a great deal of anxiety for the patient to have a biopsy performed. Practice shows that many biopsies are not performed even though a cancer would have been found, and at the same time, biopsies are performed that would not have been necessary. The Exosome test improves the clinical decision making enormously and is a real blessing for patients.

IZB Biotech News: Where is the test from Exosome available?
Mikkel Noerholm: Until now, the test was only available in the USA through Exosome Diagnostics’ CLIA accredited clinical laboratory. Now we are bringing the test to the European market as a CE-IVD distributed test that can be performed in third party clinical laboratories. Exosome Diagnostics now offers this test from our clinical laboratories at IZB, while we work with partnering laboratories to make it available to patients and clinics across Europe.

IZB Biotech News: What does your European location in the IZB mean to you?
Mikkel Noerholm: The IZB is really at the heart of one of Europe´s most important biotech regions. Our location on campus here at the IZB is very important to us. We have a lot of good collaborations with world class clinicians and researchers in the immediate neighborhood.