Prostate cancer is one of the most common cancers in men, yet current screening methods like the PSA test often lack the specificity needed for accurate early detection. Through our BIOURICA 2.0 project, we are developing a non-invasive, urine-based diagnostic test that identifies novel biomarkers to significantly improve diagnostic precision. By complementing PSA testing, our method enables large-scale prostate cancer screening and has the potential to reduce unnecessary treatments, detect cancer earlier, and ultimately improve survival outcomes on a global scale.

While PSA testing is the standard method in prostate cancer diagnostics, it has some serious deficiencies. As elevated PSA level increases the likelihood of prostate cancer, it is not a very accurate predictor. Based on research studies:

• individuals with a PSA level below 4.0 ng/ml still have a 15% chance of having prostate cancer

• PSA levels 4.0–10.0ng/ml have a 25% risk, and with

• PSA levels above 10.0ng/ml, the probability of having PCa is just over 50%, meaning nearly half of individuals in this category do not have prostate cancer. 

(Source: The Cleveland Clinic)

Respectively, detecting metastatic prostate cancer is even more challenging, as there are no cost-efficient methods currently available. These statistical facts highlight the limitations of PSA testing in prostate cancer diagnostics, which is why there is an evident need for a complimentary test.

Aqsens phage-biosensor has demonstrated its ability to detect lethal prostate cancer variants (Kulpakko et al., 2022) and its metastasis (Juusti et al., 2024) with high accuracy from urine at a low-cost, making it a promising method to compliment PSA and enable prostate cancer screening on a larger scale. The goal of our ongoing BIOURICA 2.0 project is to validate and build cost-efficient screening for prostate cancer.

Aqsens Health’s patented phage-biosensor method delivers critical information on specific diseases and helps in discovering new disease biomarkers. The method enables cost-efficient screening of different diseases from cancers to other severe non-communicable diseases.

The BIOURICA 2.0 project brings together highly skilled professionals from biosciences, data science and AI, international business management, alongside merited clinical cancer researchers and their institutions. The project team is driven by a common goal: enabling prostate cancer screening and improving patient outcomes.

As a team we are well connected globally and have ongoing research studies and preclinical projects in Finland and in China. We have access to large complementary prostate cancer sample cohorts from Helsinki University Hospital (HUS), Turku University Hospital (TYKS), and Nanjing Cancer Hospital, which ensures that we can perform high-quality preclinical trials to confirm our phage-biosensor method’s accuracy and detection capabilities. 

According to the GLOBOCAN Global Cancer Observatory survey, there are approximately 1,4 million new prostate cancer cases every year. The annual volume for the PSA-test is over 50 million tests, with an estimated annual market value of €3.8 billion (CAGR 9.8%). However, even though the PSA test is in wide use, it is not suitable for large-scale screening because of its poor predictive value.

Aqsens Health positions its biosensor method as a complementary and affordable test to be used alongside PSA to improve prostate cancer screening and disease classification.  The annual Total Accessible Market (TAM) size for the AQ Prostate test is approximately 8% (over €300 million) depending on the value delivered. 

Within our urinary tract strategy, the company will also target bladder and kidney cancer—each representing billion-dollar market opportunities with no viable screening methods currently available. The first scientific publication on bladder cancer is underway, and sample collections are ongoing, with measurements set to begin in 2026.

Looking beyond 2025, Aqsens Health’s aim is to expand its phage-biosensor method into a scalable platform business. Leveraging the AQ Lab web platform, the company will combine its proprietary pretreatment and measurement protocols with its sensor libraries and biomarker discovery methods to enable new biomarker discoveries across multiple diseases.

The global diagnostic market, valued at over €73 billion annually, relies almost purely (70-80%) on blood analysis. In this context, Aqsens Health offers a radical new phage-biosensor method that utilizes biological samples to identify novel biomarkers for early disease detection, providing cost-efficient screening alternatives for prostate and urinary tract cancers.

Aqsens has built a strong patent portfolio for its phage-biosensor method, covering EPO, North America, and China, with opportunities to expand into complementary methods and disease-specific patents. Currently the company is using two engineered phages (x174 and M13) while also experimenting with purely human related phages with a focus on solving current diagnostic challenges. With this scientific approach, we aim to establish ourselves as a leading biotech company in this field.

As a company, we operate in a high growth area in which global diagnostic companies are gradually entering using traditional analytical measurement methods. We believe that the use of phage-biosensors offers a new avenue to understand human metabolism and its changes, whether caused by disease or environmental conditions.

Aqsens' team consists of science-driven professionals in the field of phage-biosensors, disease detection, AI and data science and business development. We work closely together with dedicated clinical and scientific institutes and advisors, who are world-class medical professionals in their own fields.

As a company we are looking for value creation multipliers of 5 - 15x for the coming 2 to 3 years.