Biomarkers-Based Diagnostic and Prognostic Tools: Reliable Prostate Cancer Testing in the U.S.

26 Oct 2023

Prostate cancer cases are rising in the U.S. compared to patients in other regions around the globe. Several factors may contribute to the higher incidence of prostate cancer in the U.S., such as age, genetics, and race.

The access to advanced healthcare and the availability and use of screening tests such as prostate-specific antigen (PSA), which can detect the disease in its early stages, are also contributing factors to the increased prevalence of prostate cancer in the U.S. 

Recent innovations in cancer testing have made early detection and treatment of cancer possible and more convenient than in earlier times.

Biomarker-based testing has been proven to be an effective method for diagnosing patients with prostate cancer. Furthermore, the development of biomarker-based diagnostic and prognostic tools has fueled the expansion of prostate cancer testing in the U.S. 

Are new biomarkers improving the reliability of prostate cancer testing?

New diagnostic and prognostic biomarkers are being developed and studied to improve the reliability of prostate cancer testing.
Biomarkers are molecules or genetic mutations found in the blood, urine, or tissue samples and can indicate the presence of cancer or help predict its behavior. Studies have shown that the use of diagnostic and prognostic tools based on biomarkers has the potential to increase the accuracy of prostate cancer testing in the U.S.

As per the report by BIS Research, the U.S. prostate cancer testing market was valued at $0.54 billion in 2021 and is projected to reach $1.90 billion in 2030, with a CAGR of 14.7%, during the forecast period 2022–2030. 

New biomarkers, such as genetic markers and MRI imaging, can potentially improve testing reliability compared to traditional biomarkers.

For example, using genetic markers such as TMPRSS2-ERG gene fusion can help identify aggressive forms of the disease that may not be detected by traditional biomarkers such as the prostate-specific antigen (PSA) test alone.
Although the PSA test is still widely used in clinical practice as a screening tool for prostate cancer, it has its limitations, such as a high rate of false positive results.

Furthermore, multiparametric MRI is more accurate than traditional biopsy methods, which can help to reduce the number of unnecessary biopsies and improve patient outcomes.

Diagnostics Biomarkers for Clinical Trials

The new biomarkers and diagnostic and prognostic methods are being studied in clinical trials to evaluate their utility in clinical practice and to determine the best way to use them in combination with existing testing methods. 

Diagnostic biomarkers
Biomarkers based on urine or blood have demonstrated promising results in predicting prostate cancer of high grade. These biomarkers provide an objective test result, and urine or blood samples may be acquired in ordinary urological practice. 

1. SelectMDx test

SelectMDx test is a non-invasive genetic test that uses urine samples to identify men at increased risk of having aggressive prostate cancer and helps in the diagnosis and management of prostate cancer.

The test looks for the presence of the TMPRSS2-ERG gene fusion, which is present in a significant percentage of men with aggressive prostate cancer. 

2. Prostate Health Index (PHI)

The Prostate Health Index (PHI) is a blood or urine-based test that measures the levels of three specific biomarkers: prostate-specific antigen (PSA), free PSA, and human glandular kallikrein 2 (Hk2). 

It is not a replacement for a biopsy but can be used as an adjunct test to help guide the decision for a biopsy. The FDA authorized it, and it is accessible commercially in the U.S., Europe, and Australia. 

3. 4K Score

The 4K Score is a blood test that measures the levels of four specific biomarkers in the blood that are used to assess the risk of prostate cancer: prostate-specific antigen (PSA), free PSA, intact PSA, and human glandular kallikrein 2 (hK2).

The 4K Score test is a tool that helps to predict the risk of prostate cancer before a biopsy is performed, and it allows urologists to identify patients who are at high risk and need to be biopsied while also identifying patients who can avoid unnecessary biopsies. 

4. PCA3/Progensa

The Progensa PCA3 test is a urine-based genetic test that helps detect prostate cancer by analyzing the genetic material (RNA) of cells the prostate sheds. It is used in conjunction with other diagnostic tools, such as a digital rectal exam and a prostate-specific antigen (PSA) blood test, to help determine the need for a prostate biopsy.

This test works by detecting the presence of a specific gene, PCA3, which is overexpressed in prostate cancer cells. The test is for men who have had an elevated PSA level or PCA3 score >35, along with an abnormal digital rectal exam and are referred for a prostate biopsy. 

5. ConfirmMDx

ConfirmMDx is a molecular diagnostic test that uses a urine sample to analyze genetic material from cells shed from the prostate. The test is used in conjunction with a prostate-specific antigen (PSA) blood test to help determine the need for a prostate biopsy.

The test looks for the presence of the TMPRSS2-ERG gene fusion, a genetic marker present in about half of all prostate cancer cases. ConfirmMDx also looks for the TMPRSS2-ETS gene fusions and PTEN loss.


Due to an aging population, growing urbanization, and accompanying lifestyle changes, the overall incidence of prostate cancer has increased in the U.S. over the past few decades.

Clinical biomarkers have become essential in the testing of prostate cancer. Biomarker-based cancer diagnostics and prognostics assist in the early detection of cancerous cells, contributing to effective treatment.

Advancement in technology has transformed healthcare and is expected to provide more convenience in patient care and reduce mortality rates.