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The Pathologist / Issues / 2025 / Mar / Advancing Prostate Cancer Diagnostics
Oncology Screening and monitoring Point of care testing Technology and innovation Liquid biopsy Opinion and Personal Narratives

Advancing Prostate Cancer Diagnostics

Why biomarker-based urinalysis should replace the PSA test

By Dave Taylor 03/28/2025 Opinion 3 min read

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Credit: Valley Diagnostics

Awareness of the incidence and challenges around prostate cancer has been rising in recent years, with a number of high-profile public figures – including cyclist Chris Hoy and restaurant critic Giles Coren – bravely making their diagnoses public. The resultant visibility has added to the rise in voices calling for easier, earlier, and more accurate testing, and a properly implemented screening programme.

The statistics back this up, with a worldwide annual death rate from prostate cancer of over 375,000 men (1). In the UK, over 12,000 men die every year from the disease – equivalent to 33 men every day (2). In the USA it is around 100 men every day (3).  

Prostate cancer tests are usually offered only when symptoms are present. As the majority of early-stage cases are non-symptomatic, testing often happens too late, when the cancer is at stage 3 or 4. 

What we have

Men aged over 50 are encouraged by healthcare providers to take the industry standard prostate-specific antigen (PSA) test for indicating prostate problems, including prostate cancer. 

PSA is a protein produced by normal, as well as malignant, cells of the prostate gland. Both prostate cancer and several benign conditions – particularly benign prostatic hyperplasia (BPH), and prostatitis – can cause PSA levels in the blood to rise. The established PSA test is therefore regarded as only an indicator of potential prostate-related problems.

If the test shows an abnormally raised level of PSA, then the patient is generally referred for additional testing, including: an internal examination, a magnetic resonance imaging scan, a biopsy, and additional genetic tests. All of these add significant extra costs.

What we need

The current testing process is expensive, time-consuming, invasive, and unlikely to detect prostate cancer at an early stage.

What’s more, the overall accuracy of the PSA test has been shown to be extremely low. False-positive test results are common – at around 6 to 7 percent – and only about 25 percent of patients who eventually have a biopsy due to an elevated PSA level are found to have prostate cancer (4). In fact, in the USA, the PSA test is not recommended for routine prostate cancer screening in the general population.

There is an urgent need for better prostate cancer testing methods. 

Several tests are in development, primarily using blood. The problem is that they all involve molecular tests that require special expertise and are logistically complex, time-consuming, and expensive. The turnaround time from taking a sample to the return of the results can be five working days or more.

However, an alternative testing method is now being developed that could overcome these challenges…

Bring in the biomarkers

Several biomarkers have been identified in the urine of men with prostate cancer – leading to development of a multi-biomarker variant of the lateral flow test (LFT) that can be performed at the point of care and gives results within minutes. 

This test will have the ability to diagnose early-stage prostate cancer as well as distinguishing prostate cancer from BPH. Another advantage is that it will require only a naturally expressed urine sample, avoiding the need for an invasive blood extraction.

The greater accessibility of the LFT means it is more likely to be used by younger men, detecting the cancer at a much earlier stage when effective interventions can be made. 

Biomarker LFTs provide 95 percent accuracy, are low-cost, and easy-to-use in comparison with the current standard of testing. With the potential to save thousands of lives every year across the UK and the world, LFTs must be the way forward for decentralized testing and personalized care for men.

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References

  1. International Agency for Research on Cancer, "Global Cancer Observatory" (2022). Available at: https://gco.iarc.fr/today/home
  2. Prostate Cancer UK, "About Prostate Cancer" (2025). Available at:  https://prostatecanceruk.org/prostate-information-and-support/risk-and-symptoms/about-prostate-cancer
  3. Centers for Disease Control and Prevention, “Prostate Cancer Stat Bite” (2024). Available at: https://www.cdc.gov/united-states-cancer-statistics/publications/prostate-cancer-stat-bite.html
  4. RL Grubb 3rd et al., “Prostate cancer screening in the prostate, lung, colorectal and ovarian cancer screening trial: Update on findings from the initial four rounds of screening in a randomized trial,” BJU International, 102, 11 (2008). PMID: 19035857.

About the Author(s)

Dave Taylor

CEO of Valley Diagnostics

More Articles by Dave Taylor

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