Biomarkers-Based Diagnostic and Prognostic Tools: Reliable Prostate Cancer Testing in the U.S.
Prostate cancer cases are rising in the U.S. compared to cases in other regions around the globe. There are several factors that 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.
The goal of prostate cancer testing is to reduce mortality and improve the quality of living for the patients.
Through recent innovations in cancer testing, early detection and treatment of cancer have been made 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 fuelled the expansion 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.
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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 that can be 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.
New biomarkers, such as genetic markers and MRI imaging, have the potential to improve the reliability of testing compared to traditional biomarkers.
For example, the use of genetic markers such as TMPRSS2-ERG gene fusion can help to 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 own limitations, such as a high rate of false positive results.
Furthermore, multiparametric MRI has been shown to be more accurate than traditional biopsy methods, which can help to reduce the number of unnecessary biopsies and improve patient outcomes.
The newer biomarkers and diagnostic as well as 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.
A. 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.
This test is intended to be used in conjunction with other diagnostic tools, such as a digital rectal exam and prostate-specific antigen (PSA) testing, to help physicians make more informed decisions about the need for further testing and treatment.
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).
These biomarkers are used to assess the risk of prostate cancer. The test is used to help distinguish between benign prostate conditions and prostate cancer, particularly in men with elevated PSA levels.
It is not a replacement for a biopsy but can be used as an adjunct test to help guide the decision for a biopsy.
It was authorized by the FDA and 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 more complex version of the Prostate Health Index (PHI) which uses only three biomarkers.
The 4K Score test is a tool that helps to predict the risk of prostate cancer before a biopsy is performed, and it helps urologists to identify patients who are at high risk and need to be biopsied while also identifying patients who can avoid unnecessary biopsies.
It has been certified by the CLIA program of the Centers for Medicare and Medicaid Services.
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 shed by the prostate.
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.
The 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 that have been 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, which is a genetic marker that is present in about half of all prostate cancer cases.
ConfirmMDx also looks for the TMPRSS2-ETS gene fusions and PTEN loss.
It is used to help distinguish between prostate cancer and other prostate conditions, such as benign prostatic hyperplasia (BPH).
B. Prognostic biomarkers
Prognostic biomarkers play an important role in detecting and managing prostate cancer. These biomarkers are molecular markers that can help to predict the likelihood of recurrence, progression, and overall survival in prostate cancer patients.
Tissue-based prognostic biomarker tests are commonly used in the detection and management of prostate cancer.
These tests are performed on a tissue sample obtained through a biopsy of the prostate and provide crucial information about the clinical condition of cancer.
1. Prolaris
Prolaris is a tissue-based genetic test that uses a patient’s tumor sample to assess the aggressiveness of prostate cancer.
The tissue sample is obtained through a biopsy and is analyzed using a proprietary gene expression assay.
The test analyzes the activity of 31 genes associated with prostate cancer progression and provides a score that can be used to predict the likelihood of prostate cancer progression.
The test results are reported as a continuous score, with higher scores indicating a greater risk of prostate cancer progression.
The test can be used to identify men with prostate cancer who may benefit from further therapy or who may be candidates for active surveillance, which is a strategy for monitoring cancer without immediate treatment.
The test results may also be used in combination with other patient characteristics, such as PSA level and Gleason score, to make treatment decisions.
According to NCCN guidelines issued in 2016, the Prolaris test has been recommended for individuals having extremely low and low-risk illnesses on biopsy, along with a 10-year of life expectancy.
2. Decipher
Decipher is another tissue-based genetic test that uses tissue samples to determine to determine genomic classifier (GC) risk scores.
These GC risk scores predict the progression of prostate cancer and its risk of spreading to distant sites (metastasis).
The Genome Classifier (GC) risk score examined 22 genes involved in cell proliferation, cell migration, tumor growth, androgen signaling, and immune system evasion.
According to the NCCN guidelines issued in 2016, the Decipher test has been recommended for persons with critical medical conditions after radical prostatectomy (RP).
3. Oncotype DX
Oncotype is a tissue-based biomarker prognostic test that involves the determination of the GC risk score of prostate cancer by analyzing 17 genes.
However, 12 genes out of 17 are responsible for identifying cancer growth related to prostate cancer; the remaining five genes are in charge of androgen signaling, cell proliferation, and organization.
The NCCN guidelines issued in 2016 suggest an Oncotype DX test for patients with a very low- or low-risk disease at the time of diagnosis and a life expectancy of 10 to 20 years.
Conclusion
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. The biomarker-based cancer diagnostics and prognostics assist in the early detection of cancerous cells, which also contributes to effective treatment.
Advancement in technology has transformed healthcare and is expected to provide more convenience in patient care as well as reduce mortality rates.
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